2018 Product Reference Charts - Protein Therapies - BDI Pharma, LLC

 
2018 Product Reference Charts - Protein Therapies - BDI Pharma, LLC
BDI Pharma, LLC

2018
Product Reference
Charts

Protein Therapies
2018 Product Reference Charts - Protein Therapies - BDI Pharma, LLC
Intravenous Immune Globulin (10%)                                                                                                                                                                                                                                          800.948.9834             |       www.bdipharma.com

                                               BIVIGAM® NF                                                          Flebogamma® 10% DIF                                                            GAMMAGARD LIQUID                                                                    Gammaked®
Product Specifics
                                               ADMA Biologics                                                                   Grifols                                                                        Shire                                                                        Kedrion

                                                                                                                                                                                                                                                          Gammaked is an immune globulin injection (human), 10% liquid indicated
                                                                                                                                                                                Replacement therapy for primary humoral immunodeficiency (PI) in          for treatment of: Primary Humoral Immunodeficiency (PI) in patients 2 years
                           BIVIGAM® is an Immune Globulin Intravenous (Human),
                                                                                                     Primary Immune Deficiency (PID), Chronic Primary Immune                     adult and pediatric patients two years of age or older. Maintenance          of age and older, Idiopathic Thrombocytopenic Purpura (ITP) in adults
      Indications         10% Liquid, indicated for the treatment of primary humoral
                                                                                                    Thrombocytopenia (ITP) in patients 2 years of age and older.              therapy to improve muscle strength and disability in adult patients with     and children, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
                                            immunodeficiency (PI)
                                                                                                                                                                                               Multifocal Motor Neuropathy [MMN].                          in adults. Gammaked may also be administered subcutaneously for the
                                                                                                                                                                                                                                                                                         treatment of PI.

                                                                                                                                                                               1. In patients who have had a history of anaphylactic or severe
                          BIVIGAM® is contraindicated in patients who have had an
                                                                                                                                                                                  systemic hypersensitivity reaction to the administration of human
                       anaphylactic or severe systemic reaction to the administration of                                                                                                                                                                  Gammaked is contraindicated in patients who have had an anaphylactic
                                                                                                Individuals who have had a history of anaphylactic or severe systemic             immune globulin.
                                          human immune globulin.                                                                                                                                                                                            or severe systemic reaction to the administration of human immune
Contraindications                                                                            reactions to the administration of human immune globulin and IgA deficient         2. In IgA-deficient patients with antibodies to IgA and a history of
                                                                                                                                                                                                                                                           globulin. Gammaked is contraindicated in IgA deficient patients with
                                                                                                    patients with antibodies to IgA and a history of hypersensitivity.            hypersensitivity. Anaphylaxis has been reported with intravenous
                          BIVIGAM® is contraindicated in IgA deficiency patients with                                                                                                                                                                               antibodies against IgA and history of hypersensitivity.
                                                                                                                                                                                  use of GAMMAGARD LIQUID and is theoretically possible
                               antibodies to IgA and a history of hypersensitivity.
                                                                                                                                                                                  following subcutaneous use.

                                                                                                        Flebogamma 10% DIF contains trace amounts of IgA                                         The average immunoglobulin A
     IgA Content                                ≤ 200 mcg/mL
                                                                                                         (typically less than 100 μg/mL) Average: 3.1 μg/mL                           (IgA) concentration is 37 mcg/mL (in a 10% solution).
                                                                                                                                                                                                                                                                                     Average 46 mcg/mL

       Osmolality                              370-510 mOsm/kg                                                           240-370 mOsm/kg                                                              240 - 300 mOsmol/kg                                                              258 mOsmol/kg

   Sugar Content                     BIVIGAM® does not contain sucrose                                                  5% D-sorbitol (polyol)                                                           No sugar added                                                     Gammaked does not contain sucrose

  Sodium Content                       0.100-0.140 M sodium chloride                                                    Trace (< 3.2 mmol/L)                                                            No sodium added                                                                 Trace amounts

    pH of Product                                  4.0 - 4.6                                        The pH of the solution ranges from 5 to 6. Average: 5.5 ± 0.1                                            4.6 - 5.1                                                                     4.0 - 4.5

                                        The median terminal half-life of
 Product Half Life                         BIVIGAM® was 30 days
                                                                                             3-week dosing interval: 34 ± 10 days; 4-week dosing interval: 37 ± 13 days                          26 – 35 days for Intravenous use                                                   Approximately 35 days

                                                                                                                                                                                                                                                                 Gammaked is made from large pools of human plasma by a
                      Precipitation and removal of fraction III removes both enveloped and        Pasteurization at 60 ºC, 10 hours, solvent-detergent treatment for
      Viral Safety                                                                                                                                                                                                                                         combination of cold ethanol fractionation, caprylate precipitation and
                     nonenveloped viruses, solvent/detergent treatment represents a virus        6 hours and nanofiltration down to 20 nm Planova filters. Fraction I                              Solvent Detergent, 35 nm filtration,                       filtration, and anion-exchange chromatography. Isotonicity is achieved
          Process       inactivation step for enveloped viruses, and 35 nm virus filtration       precipitation, Fraction II+III precipitation, 4% PEG precipitation and                        incubation (elevated temp) at low pH
                                                                                                                                                                                                                                                                by the addition of glycine. Gammaked is incubated in the final
                     removes both enveloped and nonenveloped viruses by size exclusion                            pH treatment for 4 hours at 37 ºC).
                                                                                                                                                                                                                                                                             container (at the low pH of 4.0–4.3).

                                                                                                                                                                                                                                                            Intravenous (IV): CIDP, PI, ITP. Check prescribing information for initial
        Route of                                                                                                                                                                                                                                           and maintenance infusion rates. Subcutaneous (SC): PI. Initial rate 20
                                               Intravenous (IV)                                                            Intravenous (IV)                                                   Intravenous (IV) or Subcutaneous (SC)
   Administration                                                                                                                                                                                                                                          mL/hr/site. Over time, the dose may need to be adjusted to achieve
                                                                                                                                                                                                                                                                  the desired clinical response and serum IgG trough level.

   Formulation &
                                                  10% Liquid                                                                 10% Liquid                                                                     10% Liquid                                                                    10% Liquid
   Concentration

                                                                                                                                                                          • Do not freeze.
                                   Refrigerate between 2 to 8°C (36 to 46°F)                                                                                              • Store GAMMAGARD LIQUID in the refrigerator or at room temperature.
         Storage                             Do not freeze or heat.                                                                                                       • Refrigeration: 2° to 8°C [36° to 46°F] for up to 36 months.                   36 months at refrigerated temperature 2°-8°C (36°-46°F). Do not freeze.
                                                                                                    Room temperature storage: + 2° to + 25°C (36° F to 77° F).
                          Do not use any solutions that have been frozen or heated.                                                                                       • Room Temperature: up to 25°C [77°F] for up to 24 months.                      6 months at temperatures not to exceed 25° (77°F) anytime during the
    Requirements                                                                                                         Do not freeze.                                   • Expiration dates for both storage conditions are printed on the outer
                     Allow refrigerated product to come to room temperature before use.                                                                                                                                                                                             36-month shelf life.
                                         Do not use after expiration date.                                                                                                  carton and vial label.
                                                                                                                                                                          • Do not use past the applicable expiration date.

   Shelf Life from
                                                                                                                                                                                  24 months at room temperature, 36 months when refrigerated,
           Date of                                24 months                                                                   24 months
                                                                                                                                                                                                    or until expiration date.
                                                                                                                                                                                                                                                                  36 months. Do not use after the labeled expiration date.
     Manufacture

                            5 g protein in (50 mL) single-use, tamper-evident vial
    How Supplied           10 g protein in (100 mL) single-use, tamper-evident vial
                                                                                                          5 g (50 mL), 10 g (100 mL), and 20 g (200 mL)                                         1.0 g, 2.5 g, 5 g, 10 g, 20 g, 30 g                       1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL)
2018 Product Reference Charts - Protein Therapies - BDI Pharma, LLC
Intravenous Immune Globulin (10%) Continued                                                                                                                                                                                                                                                                                                                                           800.948.9834                    |          www.bdipharma.com

  Product Specifics                                                       Gammaplex® 10%                                                                                                  Gamunex-C®                                                                                    Octagam® 10%                                                                                                         Privigen®
                                                                                       BPL                                                                                                       Grifols                                                                                     Octapharma                                                                                                     CSL Behring

                                                                                                                                                   GAMUNEX-C is an immune globulin injection (human), 10% liquid indicated
                                                                                                                                                   for treatment of: Primary Humoral Immunodeficiency (PI) in patients 2 years
                                             Primary Humoral Immunodeficiency (PI) in adults, Chronic Immune                                         of age and older, Idiopathic Thrombocytopenic Purpura (ITP) in adults and                                                                                                                                   Primary Humoral Immunodeficiency (PI), Chronic Immune Thrombocytopenic
               Indications                              Thrombocytopenic Purpura (ITP) in adults
                                                                                                                                                                                                                                                              Chronic immune thrombocytopenic purpura (ITP) in adults.
                                                                                                                                                      children, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in                                                                                                                                       Purpura (ITP), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
                                                                                                                                                      adults. GAMUNEX-C may also be administered subcutaneously for the
                                                                                                                                                                                  treatment of PI.

                                                                                                                                                   GAMUNEX-C is contraindicated in patients who have had an anaphylactic or                                                                                                                                          Patients who have had an anaphylactic or severe systemic reaction
                                          Patients who have a history of anaphylactic or severe systemic reactions                                                                                                                                      History of anaphylactic or severe systemic reactions to human
                                                                                                                                                    severe systemic reaction to the administration of human immune globulin.                                                                                                                                           to the administration of human immune globulin. Patients with
   Contraindications                      to human immune globulin and IgA-deficient patients with antibodies to
                                                                                                                                                     GAMUNEX-C is contraindicated in IgA deficient patients with antibodies
                                                                                                                                                                                                                                                    immunoglobulin. IgA deficient patients with antibodies against IgA and a
                                                                                                                                                                                                                                                                                                                                                                   hyperprolinemia. Patients with selective IgA deficiency with antibodies to
                                                           IgA and a history of hypersensitivity.                                                                                                                                                                         history of hypersensitivity.
                                                                                                                                                                   against IgA and history of hypersensitivity.                                                                                                                                                                      IgA and a history of hypersensitivity.

             IgA Content                                                        < 20 mcg/mL                                                                                             Average 46 mcg/mL                                                       Trace amounts (average 106 μg/mL in a 10% solution).                                                                                       ≤ 25 mcg/mL

               Osmolality                                               Typically 280 mOsmol/kg                                                                                           258 mOsmol/kg                                                                               310 - 380 mOsmol/kg.                                                                         Approximately 320 mOsmol/kg (range: 240-440)

                                                                                                                                                                                                                                                                                                                                                                                        None. L-Proline, a nonessential amino acid,
         Sugar Content                                                             No sugar                                                                                GAMUNEX-C does not contain sucrose                                                                  Maltose (90 mg/mL), no sucrose.
                                                                                                                                                                                                                                                                                                                                                                                                  is used as a stabilizer.

      Sodium Content                                                                < 5 mM                                                                                                 Trace amounts                                                                            Not more than 30 mmol/L.                                                                                                     Trace

          pH of Product                                                             4.9 - 5.2                                                                                                   4.0 - 4.5                                                                                       4.5 - 5.0                                                                                             4.8 (range is 4.6 - 5.0)

                                                                                                                                                                                                                                                                                                                                                                                   Mean 3-week dosing interval = 27.6 ± 5.9 days
     Product Half Life                                                  4-week dosing: 34.8 days                                                                                      Approximately 35 days                                                 Not tested in primary humoral immunodeficiency (PI) patients
                                                                                                                                                                                                                                                                                                                                                                                   Mean 4-week dosing interval = 45.4 ± 18.5 days

                                                                                                                                                    GAMUNEX-C is made from large pools of human plasma by a combination
              Viral Safety                                                                                                                         of cold ethanol fractionation, caprylate precipitation and filtration, and anion-                                                                                                                                              pH 4 incubation, 20nm virus filtration, depth filtration;
                                                  Solvent detergent, nanofiltration, terminal low pH incubation                                                                                                                                             Cold-ethanol fractionation, S/D treatment, and pH 4 treatment.
                  Process                                                                                                                          exchange chromatography. Isotonicity is achieved by the addition of glycine.                                                                                                                                                              TSE validation and removal
                                                                                                                                                    GAMUNEX-C is incubated in the final container (at the low pH of 4.0–4.3).

                                                                                                                                                     Intravenous (IV): CIDP, PI, ITP. Check prescribing information for initial and
              Route of                                                                                                                               maintenance infusion rates. Subcutaneous (SC): PI. Initial rate 20 mL/hr/
                                                                               Intravenous (IV)                                                                                                                                                                                            Intravenous (IV)                                                                                               Intravenous (IV)
         Administration                                                                                                                              site. Over time, the dose may need to be adjusted to achieve the desired
                                                                                                                                                                    clinical response and serum IgG trough level.

         Formulation &
                                                                                  10% Liquid                                                                                                  10% Liquid                                                                                      10% Liquid                                                                                                     10% Liquid
         Concentration

                                       When stored between 2 °C [35.6 °F] and 25 °C [77 °F]), GAMMAPLEX 10%                                           36 months at refrigerated temperature 2°-8°C (36°-46°F). Do not freeze.                                                                                                                                        Store at room temperature up to 25°C (77°F) for up to 36 months, as
               Storage                                                                                                                                                                                                                                             Do not freeze. Frozen product should not be used.
                                       has a shelf life of 36 months. Do not freeze. Keep GAMMAPLEX 10% in its                                        6 months at temperatures not to exceed 25° (77°F) anytime during the                                                                                                                                         indicated by the expiration date printed on the outer carton and vial label.
          Requirements                                                                                                                                                                                                                                                      Do not use after expiration date.
                                                            original carton to protect it from light.                                                                           36-month shelf life.                                                                                                                                                                                    Do not freeze. Protect from light.

        Shelf Life from                                                                                                                                                                                                                           24 months at +2°C to + 8°C (36°F to 46°F) from the date of manufacture.
                Date of                                                           36 months                                                                     36 months. Do not use after the labeled expiration date.                          Within the first 12 months of this shelf-life, the product may be stored up to                                                                               36 months
          Manufacture                                                                                                                                                                                                                                                   9 months at ≤ +25°C (77°F).

                                                                                                                                                     1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL),                                                                                                                                                                      5 g (50 mL), 10 g (100 mL),
          How Supplied                                      5 g (50 mL), 10 g (100 mL), 20 g (200 mL)
                                                                                                                                                                                  40 g (400 mL)
                                                                                                                                                                                                                                                                  Supplied in 2 g, 5 g, 10 g or 20 g single use bottles.
                                                                                                                                                                                                                                                                                                                                                                                                20 g (200 mL), 40 g (400 mL)

DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced            on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions
from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at 1-800-948-9834.   The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information. ©2018 BDI Pharma, LLC. All rights reserved.
2018 Product Reference Charts - Protein Therapies - BDI Pharma, LLC
Intravenous Immune Globulin (5% & Lyophilized)                                                                                                                                                                                                              800.948.9834         |      www.bdipharma.com

Product Specifics                        Carimune® NF                                          Flebogamma® 5% DIF                               Gammagard S/D (IgA > 1 μg/mL)                                     Gammaplex® 5%                                              Octagam® 5%
                                           CSL Behring                                                   Grifols                                                 Shire                                                     BPL                                                 Octapharma

                                                                                                                                               Treatment of Primary Immunodeficiency (PI)
                                                                                                                                               in adults and pediatric patients two years of
                                                                                                                                             age or older. Prevention of bacterial infections
                                                                                                                                              in hypogammaglobulinemia and/or recurrent              Primary Humoral Immunodeficiency in adults
                                                                                         The treatment of primary (inherited)
      Indications               Primary Immune Deficiency (PID)                                                                             bacterial infections associated with B-cell Chronic         and pediatric patients 2 years of age and
                                                                                     immunodeficiency (PI) in adults and pediatric                                                                                                                                Primary humoral immunodeficiency (PI).
                                     Acute ITP, Chronic ITP                                                                                  Lymphocytic Leukemia (CLL). Prevention and/              older, Chronic Immune Thrombocytopenic
                                                                                         patients 2 years of age and older.                 or control of bleeding in adult Chronic Idiopathic                       Purpura (ITP)
                                                                                                                                          Thrombocytopenic Purpura (ITP) patients. Prevention
                                                                                                                                             of coronary artery aneurysms associated with
                                                                                                                                                 Kawasaki syndrome in pediatric patients.

                           Contraindicated in patients with selective                                                                                                                             History of anaphylactic or severe systemic reactions         Anaphylactic or severe systemic reactions
                         IgA deficiency, who possess antibody to IgA               Individuals who have had a history of anaphylactic                                                             to human immunoglobulin; IgA-deficient patients with
                                                                                                                                              History of anaphylactic or severe systemic                                                                        to human immunoglobulin. IgA deficient
Contraindications         or hypersensitivity to immunoglobulins. It is          or severe systemic reactions to the administration of                                                             antibodies to IgA and a history of hypersensitivity.
                                                                                                                                           hypersensitivity reactions to the administration of                                                                patients with antibodies against IgA and a
                           contraindicated in patients who have had             human immune globulin and IgA deficient patients with                                                              Hereditary intolerance to fructose, also in infants and
                                                                                                                                          GAMMAGARD S/D
2018 Product Reference Charts - Protein Therapies - BDI Pharma, LLC
Subcutaneous Immune Globulin                                                                                                                                                                                                                                                                                                                                                                      800.948.9834                    |          www.bdipharma.com

                                                                                                                                                                                                                                                                                                                                                                                                              HYQVIA®
  Product Specifics                                       CUVITRU                                          GAMMAGARD LIQUID                                                       Gammaked®                                                   Gamunex-C®                                                        Hizentra®                                                                                           Shire
                                                               Shire                                                        Shire                                                      Kedrion                                                      Grifols                                                    CSL Behring
                                                                                                                                                                                                                                                                                                                                                               Recombinant Human Hyaluronidase                             Immune Globulin Infusion (Human) 10%

                                                                                                                                                   Gammaked is an immune globulin injection                                 GAMUNEX-C is an immune globulin injection                            Replacement therapy for primary
                                                                                                                                                  (human), 10% liquid indicated for Intravenous                             (human), 10% liquid indicated for Intravenous                       humoral immunodeficiency (PI) in
                                           CUVITRU is an Immune Globulin                            Replacement therapy for primary humoral             (IV) treatment of: Primary Humoral                                        (IV) treatment of: Primary Humoral                        adults and pediatric patients 2 years of
                                        Subcutaneous (Human), 20% solution                             immunodeficiency (PI) in adult and           Immunodeficiency (PI) in patients 2 years of                               Immunodeficiency (PI) in patients 2 years of                     age and older. This includes, but is not
                                         indicated as replacement therapy for                      pediatric patients two years of age or older. age and older, Idiopathic Thrombocytopenic                                  age and older, Idiopathic Thrombocytopenic                      limited to, the humoral immune defect                                   HYQVIA is an immune globulin with a recombinant human hyaluronidase
               Indications            primary humoral immunodeficiency (PI) in                        Maintenance therapy to improve muscle         Purpura (ITP) in adults and children, Chronic                             Purpura (ITP) in adults and children, Chronic                     in congenital agammaglobulinemia,                                      indicated for the treatment of Primary Immunodeficiency (PI) in adults
                                       adult and pediatric patients two years of                   strength and disability in adult patients with Inflammatory Demyelinating Polyneuropathy                                   Inflammatory Demyelinating Polyneuropathy                         common variable immunodeficiency,
                                                    age and older.                                     Multifocal Motor Neuropathy [MMN].             (CIDP) in adults. Gammaked may also                                      (CIDP) in adults. GAMUNEX-C may also                         X-linked agammaglobulinemia, Wiskott-
                                                                                                                                                     be administered subcutaneously for the                                    be administered subcutaneously for the                       Aldrich syndrome, and severe combined
                                                                                                                                                                  treatment of PI.                                                          treatment of PI.                                           immunodeficiencies.

                                                                                                      1. In patients who have had a history
                                                                                                                                                                                                                                      GAMUNEX-C is contraindicated
                                           Anaphylactic or severe systemic                              of anaphylactic or severe systemic                                                                                                                                                          Individuals who have had an
                                                                                                                                                                 Gammaked is contraindicated in patients                                 in patients who have had an
                                      hypersensitivity reactions to subcutaneous                          hypersensitivity reaction to the                                                                                                                                                        anaphylactic or severe systemic
                                                                                                                                                                 who have had an anaphylactic or severe                               anaphylactic or severe systemic
                                         administration of Immune Globulin                         administration of human immune globulin.                                                                                                                                                    reactions to human immune globulin                              History of anaphylactic or severe systemic hypersensitivity reactions to Immune
                                                                                                                                                                 systemic reaction to the administration of                             reaction to the administration
                                                        (Human)                                    2. In IgA-deficient patients with antibodies                                                                                                                                                  or components of Hizentra®, such                             Globulin (Human). IgA deficient patients with antibodies against IgA and a history of
   Contraindications                                                                                                                                              human immune globulin. Gammaked is                                      of human immune globulin.
                                                                                                     to IgA and a history of hypersensitivity.                                                                                                                                                  as polysorbate 80. Individuals with                           hypersensitivity. Known systemic hypersensitivity to hyaluronidase or Recombinant
                                          IgA deficient patients with antibodies                                                                                   contraindicated in IgA deficient patients                            GAMUNEX-C is contraindicated
                                                                                                       Anaphylaxis has been reported with                                                                                                                                                          hyperprolinemia. IgA-deficient                                                      Human Hyaluronidase of HYQVIA.
                                               against IgA and a history of                                                                                      with antibodies against IgA and history of                              in IgA deficient patients with
                                                                                                   intravenous use of GAMMAGARD LIQUID                                                                                                                                                          patients with antibodies against IgA
                                                    hypersensitivity.                                                                                                         hypersensitivity.                                     antibodies against IgA and history of
                                                                                                      and is theoretically possible following                                                                                                                                                    and a history of hypersensitivity.
                                                                                                                                                                                                                                                hypersensitivity.
                                                                                                                subcutaneous use.
                                                                                                       The average immunoglobulin A (IgA)                                                                                                                                                                                                                                                                                    The average immunoglobulin A (IgA)
                                        Contains trace amounts of IgA (average                                                                                                                                                                                                               The IgA concentration in a 20% solution
             IgA Content                                                                              concentration is 37mcg/mL (in a 10%                                      Average 46 mcg/mL                                            Average 46 mcg/mL                                                                                                                        N/A                                    concentration is 37 mcg/mL (in a 10%
                                            concentration of 80 mcg/mL).                                                                                                                                                                                                                                is < 50 mcg/mL
                                                                                                                    solution).                                                                                                                                                                                                                                                                                                             solution).

               Osmolality                 280-292 milli-osmoles per kilogram.                                   240 - 300 mOsmol/kg                                               258 mOsmol/kg                                               258 mOsmol/kg                                                   380mOsm/kg                                                290 to 350 mOsm/kg                                                240-300 mOsmol/kg

         Sugar Content                                 No added sugars                                              No sugar added                                  Gammaked does not contain sucrose                             GAMUNEX-C does not contain sucrose                                        No added sugars                                                No added sugars                                                 No added sugars

      Sodium Content                                  No sodium added                                              No sodium added                                                 Trace amounts                                               Trace amounts                                                  Trace amounts                                                     8.5 mg/mL                                                  No sodium added

          pH of Product                                     4.6 to 5.1                                                    4.6 - 5.1                                                    4.0 - 4.5                                                   4.0 - 4.5                                                      4.6 - 5.2                                                          7.4                                                          4.6-5.1

                                                                                                                                                                   Gammaked is made from large pools                          GAMUNEX-C is made from large pools of
                                                                                                                                                                                                                                                                                                                                                            • Comprehensive virus testing at the
                                                                                                                                                                     of human plasma by a combination                          human plasma by a combination of cold
                                                                                                                                                                                                                                                                                                                                                              Master Cell Bank, Working Cell Bank,
                                                                                                                                                                   of cold ethanol fractionation, caprylate                  ethanol fractionation, caprylate precipitation
                                       Solvent/detergent (S/D) treatment, 35 nm                                                                                                                                                                                                                                                                               and bulk harvest stage                                            • S/D treatment
              Viral Safety                                                                               Solvent Detergent, 35 nm filtration,                        precipitation and filtration, and anion-                       and filtration, and anion-exchange                         pH 4.0 incubation; 20nm virus filtration,
                                       nanofiltration, and a low pH incubation at                                                                                                                                                                                                                                                                            • Effective virus reduction during the                              • 35 nm filtration
               Processes                 elevated temperature (30°C to 32°C).
                                                                                                       incubation (elevated temp) at low pH                        exchange chromatography. Isotonicity                        chromatography. Isotonicity is achieved                     depth filtration; TSE validation and removal
                                                                                                                                                                                                                                                                                                                                                              purification process                                               • Incubation at low pH
                                                                                                                                                                   is achieved by the addition of glycine.                    by the addition of glycine. GAMUNEX-C is
                                                                                                                                                                                                                                                                                                                                                            • Use of pharmaceutical grade
                                                                                                                                                                     Gammaked is incubated in the final                       incubated in the final container (at the low
                                                                                                                                                                                                                                                                                                                                                              human albumin
                                                                                                                                                                    container (at the low pH of 4.0–4.3).                                   pH of 4.0–4.3).

         Formulation &
                                                          20% Liquid                                                    10% Liquid                                                   10% Liquid                                                  10% Liquid                                                     20% Liquid                                                                                     10% Liquid
         Concentration

                                                                                                    • Do not freeze.
                                                                                                    • Store GAMMAGARD LIQUID in the
                                      Store at 2°C to 8°C [36° F to 46° F] for up
                                                                                                      refrigerator or at room temperature
                                     to 36 months or Room temperature (not to                                                                                                                                                                                                                                                                                                                      Do not freeze.
                                                                                                    • Refrigeration: 2° to 8°C [36° to 46°F]
                                      exceed 25°C [77°F]) for up to 12 months.                                                                                     36 months at refrigerated temperature                           36 months at refrigerated temperature                                                                                    Keep the vials in the carton in order to protect from light. Refrigeration: 2° to 8°C [36°
                                                                                                      for up to 36 months.
                                     Do not return CUVITRU to the refrigerator if                                                                                    2°-8°C (36°-46°F). Do not freeze.                               2°-8°C (36°-46°F). Do not freeze.                          Stable when stored up at room                              to 46°F] for up to 36 months. Room Temperature: up to 25°C [77°F] for up to 3 months
               Storage                                                                              • Room Temperature: up to 25°C [77°F]
                                     you take it out to room temperature. Do not                                                                                     6 months at temperatures not to                                 6 months at temperatures not to                         temperature up to 25°C (77°F) for 30                            during the first 24 months from the date of manufacturing (Mfg. date) printed on the
          Requirements                freeze. Do not shake. Keep the vials in the
                                                                                                      for up to 24 months.
                                                                                                                                                                    exceed 25°C (77°F) anytime during                               exceed 25°C (77°F) anytime during                       months. Do not freeze. Protect from light.                      carton. HYQVIA must be used within 3 months after removal to room temperature but
                                                                                                    • Expiration dates for both storage
                                     carton in order to protect from light. Discard                                                                                       the 36-month shelf life.                                        the 36-month shelf life.                                                                                            within the expiration date on the carton and vial label. Do not return HYQVIA to the
                                                                                                      conditions are printed on the outer
                                       any unused product. Do not use past the                                                                                                                                                                                                                                                                                             refrigerator after it has been stored at room temperature.
                                                                                                      carton and vial label.
                                                    expiration date
                                                                                                    • Do not use past the applicable
                                                                                                      expiration date.

                                                                                                        24 months at room temperature, 36                                                                                                                                                                                                                               Refrigeration: 2° to 8°C [36° to 46°F] for up to 36 months.
Shelf Life from Date                  Up to 36 months when refrigerated. Up to                                                                                    36 months. Do not use after the labeled                         36 months. Do not use after the labeled
                                                                                                         months when refrigerated, or until                                                                                                                                                         30 months room temperature                                Room Temperature: up to 25°C [77°F] for up to 3 months during the first 24 months
    of Manufacture                        12 months at room temperature.
                                                                                                                 expiration date
                                                                                                                                                                             expiration date.                                                expiration date.
                                                                                                                                                                                                                                                                                                                                                                                      from the date of manufacturing.

                                                                                                                                                                                                                                                                                                                                                                                               Dual vial unit of two single use vials
                                                                                                                                                                                                                                                    Vial
                                                   Single use vials                                                                                                                Vial                                                                                                          Single use, tamper evident vial
                                                                                                                         Vial                                                                                                     1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL),
          How Supplied                    1 g (5mL), 2 g (10mL), 4 g (20mL),                                                                                     1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL),                                                                                     1 g (5 mL), 2 g (10 mL), 4 g (20 mL)                          1.25 mL (200 units), 2.5 mL (400 units),
                                                                                                         1.0 g, 2.5 g, 5 g, 10 g, 20 g, 30 g                                                                                           10 g (100 mL), 20 g (200 mL)                                                                                                                                                         25 mL (2.5 g), 50 mL (5.0 g), 100 mL
                                                      8 g (40mL)                                                                                                      10 g (100 mL), 20 g (200 mL)                                                                                                     and 10 g (50 mL)                                    5.0 mL (800 units), 10.0 mL (1600 units),
                                                                                                                                                                                                                                               40 g (400 mL)                                                                                                                                                              (10.0 g), 200 mL (20.0 g), 300 mL (30 g)
                                                                                                                                                                                                                                                                                                                                                                     15.0 mL (2400 units)

DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced                        on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions
from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at 1-800-948-9834.               The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information. ©2018 BDI Pharma, LLC. All rights reserved.
2018 Product Reference Charts - Protein Therapies - BDI Pharma, LLC
What could simplified dosing mean
for your patients on ELOCTATE ?
                                                                                                                        ®

                 Potential to dose                                               Same reconstitution                                                                    Less space needed
                 with a single vial*                                             process, fewer vials                                                                   for storage

                                                                                                         10 dosage strengths available

Now with 4000-, 5000-, and 6000-IU-strength vials,
ELOCTATE offers the potential for single-vial dosing
                                                                                                          Graphic is for illustrative purposes only.
                                                                                                         *Dosing and frequency may vary based on individual patient response.
Indications and Important Safety Information
Indications
ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII
deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
Limitation of Use
ELOCTATE is not indicated for the treatment of von Willebrand disease.
CONTRAINDICATIONS: ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE or its excipients.
WARNINGS AND PRECAUTIONS: Hypersensitivity reactions have been reported with ELOCTATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with
Factor VIII replacement products. Immediately discontinue ELOCTATE and initiate appropriate treatment if hypersensitivity reactions occur. Formation of neutralizing antibodies (inhibitors) to
Factor VIII has been reported following administration of ELOCTATE, including in previously untreated patients. Patients using ELOCTATE should be monitored for the development of Factor VIII
inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor VIII levels have been achieved and maintained.
ADVERSE REACTIONS: The most frequently occurring adverse reactions (>0.5% of subjects) in clinical trials were arthralgia, malaise, myalgia, headache, and rash.
Please see enclosed Full Prescribing Information.

                                                                     Visit ELOCTATEpro.com for more information

                                                                                                                                                                       ©2018 Bioverativ. All rights reserved. ELO-US-6015 01/18
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Recombinant Factor VIII (Page 1 of 2)                                                                                                                                                                                                                                                                                                                                                               800.948.9834                    |          www.bdipharma.com

  Product Specifics                                               ADVATE®                                                                         ADYNOVATE®                                                                                    AFSTYLATM                                                                              ELOCTATETM                                                                              Helixate® FS
                                                                      Shire                                                                               Shire                                                                                  CSL Behring                                                                               Bioverativ                                                                            CSL Behring

                                                                                                                                                                                                                     AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain,
                                         Indicated for use in children and adults with hemophilia                  ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is                                                                                                                             In adults and children with Hemophilia A (congenital Factor
                                                                                                                                                                                                                     is a recombinant, antihemophilic factor indicated in adults and
                                         A (congenital factor VIII deficiency) for:                                 a human antihemophilic factor indicated in adolescent and adult                                                                                                                           VIII deficiency) for:                                                               On-demand treatment and control of bleeding episodes in adults and
                                                                                                                                                                                                                     children with hemophilia A (congenital Factor VIII deficiency) for:
                                                                                                                   patients (12 years and older) with hemophilia A (congenital factor VIII                                                                                                                                                                                                        children with hemophilia A; Perioperative management of bleeding
                                           •   Control and prevention of bleeding episodes.                                                                                                                                                                                                                        •   Control and prevention of bleeding episodes
                                                                                                                   deficiency) for:                                                                                     •   On-demand treatment and control of bleeding episodes                                                                                                                     episodes in adults and children with hemophilia A; and Routine
                                           •   Perioperative management.                                                                                                                                                                                                                                           •   Perioperative management
               Indications                 •   Routine prophylaxis to prevent or reduce the                          •   On-demand treatment and control of bleeding episodes
                                                                                                                                                                                                                       •   Routine prophylaxis to reduce the frequency of bleeding
                                                                                                                                                                                                                                                                                                                   •   Routine prophylaxis to prevent or reduce the
                                                                                                                                                                                                                                                                                                                                                                                                  prophylaxis to reduce the frequency of bleeding episodes in adults
                                                                                                                                                                                                                           episodes                                                                                                                                                             and children with hemophilia A and reduce the risk of joint damage in
                                               frequency of bleeding episodes.                                       •   Routine prophylaxis to reduce the frequency of bleeding episodes                                                                                                                              frequency of bleeding episodes.
                                                                                                                                                                                                                       •   Perioperative management of bleeding.                                                                                                                              children without pre-existing joint damage. Helixate FS is not indicated for
                                         ADVATE is not indicated for the treatment of von                          ADYNOVATE is not indicated for the treatment of von Willebrand                                                                                                                            ELOCTATE is not indicated for the treatment of von                                                 the treatment of von Willebrand disease.
                                                                                                                   disease                                                                                           AFSTYLA is not indicated for the treatment of von Willebrand                            Willebrand disease.
                                         Willebrand disease.
                                                                                                                                                                                                                     disease.

                                                                                                                        ADYNOVATE is contraindicated in patients who have had prior                                                                                                                                 Do not use in patients who have had life-threatening
                                           ADVATE is contraindicated in patients who have life-                                                                                                                   Do not use in patients who have had life-threatening hypersensitivity                                                                                                              Do not use in patients who have life-threatening hypersensitivity
                                                                                                                    anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE),                                                                                                                             hypersensitivity reactions, including anaphylaxis, to
   Contraindications                 threatening hypersensitivity reactions, including anaphylaxis, to
                                                                                                                       mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris,
                                                                                                                                                                                                                reactions, including anaphylaxis to AFSTYLA or its excipients, or hamster
                                                                                                                                                                                                                                                                                                                  ELOCTATE or excipients of ELOCTATE (sucrose, sodium
                                                                                                                                                                                                                                                                                                                                                                                                     reactions, including anaphylaxis to mouse or hamster protein or
                                     mouse or hamster protein or other constituents of the product                                                                                                                                              proteins.                                                                                                                                                            other constituents of the product.
                                                                                                                           mannitol, trehalose, glutathione, and/or polysorbate 80).                                                                                                                             chloride, L-histidine, calcium chloride and polysorbate 20).

                                       ADVATE is a purified glycoprotein consisting of 2,332 amino
                                      acids that is synthesized by a genetically engineered Chinese                                                                                                                                                                                                         BDD-rFVIIIFc is produced by recombinant DNA technology from
        Nutrient in Cell                                                                                            The cell culture, pegylation, purification process and formulation used in                                                                                                                 a human embryonic kidney (HEK) cell line, which has been                            The cell culture medium contains Human Plasma Protein Solution
                                       hamster ovary (CHO) cell line but does not contain plasma                                                                                                                                No human or animal derived proteins are used
                                                                                                                   the manufacture of ADYNOVATE do not use additives of human or animal                                                                                                                      extensively characterized. The HEK cell line expresses BDD-                         (HPPS) and recombinant insulin, but does not contain any proteins
               Culture                  or albumin. The CHO cell line employed in the production                                                                                                                                 in the purification or formulation processes.
                                                                                                                                                       origins.                                                                                                                                            rFVIIIFc into a defined, cell culture medium that does not contain                                        derived from animal sources.
                                        of ADVATE is derived from that used in the biosynthesis of                                                                                                                                                                                                                any proteins derived from animal or human sources.
                                                              RECOMBINATE.

                                                                                                                                                                                                                                                                                                                                                                                             Sucrose (0.9-1.3%), Glycine (21-25 mg/mL), and Histidine (18-23 mM/L) in
                                                                                                                         Tris (hydroxymethyl) aminomethane, Calcium Chloride, Mannitol,                                 The reconstituted product contains the excipients: L-Histidine,
    Stabilizer in Final                Mannitol, trehalose, sodium, histidine, Tris, calcium chloride,                                                                                                                                                                                                        The reconstituted product contains the excipients: sucrose,                                             250 IU, 500 IU, 1,000 IU
                                                                                                                           Sodium Chloride, Trehalose Dihydrate, Glutathione, Histidine,                             polysorbate 80, calcium chloride, sodium chloride, sucrose, water for
         Formulation                                    polysorbate-80, glutathione                                                                                                                                                                                                                        sodium chloride, L-histidine, calcium chloride and polysorbate 20.                Sucrose (0.9-1.2%), Glycine (20-24 mg/mL and Histidine (17-22 mM/L) in
                                                                                                                          Polysorbate. There are no additives of human or animal origin.                                                           injection.
                                                                                                                                                                                                                                                                                                                                                                                                                          2000 IU, 3000 IU

                                                                                                                ADVATE is purified from the culture medium using a series of chromatography                                                                                                                        BDD-rFVIIIFc is purified using a series of chromatography
                                                                                                                columns. The purification process includes an immunoaffinity chromatography                                                                                                                         steps, including affinity capture with a recombinant, single
                                                                                                                                                                                                                                                                                                                                                                                                The purification process includes a solvent/detergent virus inactivation
                                                                                                                                                                                                                                                                                                                   chain antibody fragment produced in a yeast expression
                                                                                                                 step in which a monoclonal antibody directed against factor VIII is employed                                                                                                                                                                                                  step in addition to the use of the purification methods of ion exchange
              Viral Safety                             Immunoaffinity chromatography.                                                                                                                           AFSTYLA is purified by a controlled multi-step process including two virus                          system. No human or animal derived proteins are used in
                                                                                                                 to selectively isolate the factor VIII from the medium. The production process                                                                                                                                                                                                chromatography, monoclonal antibody immunoaffinity chromatography,
               Processes                                 Solvent/Detergent Treatment.                                                                                                                            reduction steps complementing each other in their mode of action.                                 the purification or formulation processes. The production
                                                                                                                 includes a dedicated, viral inactivation solvent-detergent treatment step. The                                                                                                                                                                                                along with other chromatographic steps designed to purify recombinant
                                                                                                                                                                                                                                                                                                                    process also incorporates two dedicated viral clearance
                                                                                                                 ADVATE molecule is then covalently conjugated with the polyethylene glycol,                                                                                                                                                                                                              factor VIII and remove contaminating substances.
                                                                                                                                                                                                                                                                                                                 steps - a detergent treatment step for inactivation and a 15
                                                                                                                                       which mainly targets lysine residues.                                                                                                                                                nm filtration step for removal of viruses.

                                                                                                                                                                                                                                          0 to 16 years: 12.0 ± 4.2, infants 8.7 ± 1.4, 2 to < 5 year
                                                                                                                                            12 to
2018 Product Reference Charts - Protein Therapies - BDI Pharma, LLC
2018 Product Reference Charts - Protein Therapies - BDI Pharma, LLC
Recombinant Factor VIII (Page 2 of 2)                                                                                                                                                                                                                                                                                                                                                         800.948.9834                    |          www.bdipharma.com

  Product Specifics                                       Kogenate® FS                                                           KOVALTRY®                                                                 Novoeight®                                                                 NUWIQ                                                                Recombinate                                                                  XYNTHA®
                                                                  Bayer                                                                Bayer                                                               Novo Nordisk                                                             Octapharma                                                                      Shire                                                                   Pfizer

                                                                                                                                                                                                                                                            NUWIQ is a recombinant antihemophilic factor [blood
                                       •     On demand treatment and control of bleeding                    Indicated for use in adults and children with                            Indicated for use in adults and children with
                                                                                                                                                                                                                                                            coagulation factor VIII (Factor VIII)] indicated in adults
                                             episodes in adults and children with hemophilia A.             hemophilia A (congenital Factor VIII deficiency) for:                     hemophilia A (congenital factor VIII deficiency or
                                                                                                                                                                                                                                                            and children with Hemophilia A for:                                                                                                                     XYNTHA, Antihemophilic Factor (Recombinant),
                                       •     Peri-operative management in adults and children                                                                                        classic hemophilia) for:
                                                                                                              •   On-demand treatment and control of bleeding                                                                                                                                                                                                                                                       is indicated for use in adults and children with
                                             with hemophilia A.                                                                                                                                                                                             •     On-demand treatment and control of bleeding                            RECOMBINATE is indicated in Hemophilia A for the
                                                                                                                  episodes                                                            •   Control and Prevention of bleeding                                                                                                                                                                                      hemophilia A (congenital factor VIII deficiency) for
                                       •     Routine prophylaxis to reduce the frequency of                                                                                                                                                                       episodes                                                              prevention and control of hemorrhagic episodes. Also
               Indications                   bleeding episodes in children with hemophilia A
                                                                                                              •   Perioperative management of bleeding                                •   Perioperative management
                                                                                                                                                                                                                                                            •     Perioperative management of bleeding                                 indicated in the perioperative management of patients
                                                                                                                                                                                                                                                                                                                                                                                                                   control and prevention of bleeding episodes and
                                                                                                              •   Routine prophylaxis to reduce the frequency of                      •   Routine prophylaxis to prevent or reduce the                                                                                                                                                                            for perioperative management. XYNTHA does not
                                             and to reduce the risk of joint damage in children                                                                                                                                                             •     Routine prophylaxis to reduce the frequency of                                         with Hemophilia A.
                                                                                                                  bleeding episodes.                                                      frequency of bleeding episodes.                                                                                                                                                                                         contain von Willebrand factor, and therefore is not
                                             without pre-existing joint damage.                                                                                                                                                                                   bleeding episodes
                                                                                                                                                                                                                                                                                                                                                                                                                         indicated in von Willebrand's disease.
                                       •     Routine prophylaxis to reduce the frequency of                 KOVALTRY is not indicated for the treatment of von                       Novoeight® is not indicated for the treatment of von
                                             bleeding episodes in adults with hemophilia A.                                                                                                                                                                 NUWIQ is not indicated for the treatment of von
                                                                                                            Willebrand disease                                                       Willebrand disease.
                                                                                                                                                                                                                                                            Willebrand Disease.

                                                                                                                                                                                                                                                                                                                                                  In patients who have manifested life-                                Do not use in patients who have manifested
                                         Do not use in patients who have life-threatening                        Do not use in patients who have history of                           Do not use in patients who have had life-threatening                         NUWIQ is contraindicated in patients who have
                                                                                                                                                                                                                                                                                                                                                 threatening immediate hypersensitivity                                 life-threatening immediate hypersensitivity
                                        hypersensitivity reactions, including anaphylaxis to                  hypersensitivity reactions to the active substance,                      hypersensitivity reactions, including anaphylaxis, to                         manifested life-threatening hypersensitivity
   Contraindications                   mouse or hamster protein or other constituents of the                  mouse or hamster protein, or other constituents of                   Novoeight® or its components (including traces of hamster                    reactions, including anaphylaxis, to the product or its
                                                                                                                                                                                                                                                                                                                                            reactions, including anaphylaxis, to the product                               reactions, including anaphylaxis, to the
                                                                                                                                                                                                                                                                                                                                            or its components, including bovine, mouse, or                            product or its components, including hamster
                                                               product                                                            the product                                                                proteins)                                                               components.
                                                                                                                                                                                                                                                                                                                                                            hamster proteins.                                                              proteins.

                                      The cell culture medium contains human plasma protein
                                                                                                                                                                                                                                                         BDD-rFVIII is produced by recombinant DNA technology in                                                                                                 The cell line is grown in a chemically defined cell
        Nutrient in Cell               solution and recombinant insulin, but does not contain                 Human- and animal-derived raw materials are not                    Novoeight® is produced using a defined cell culture medium
                                                                                                                                                                                                                                                         genetically modified human embryonic kidney (HEK) cells                                                                                                  culture medium that contains recombinant insulin,
                                      any proteins derived from animal sources. No human or                  added to the cell culture, purification, or formulation              which does not contain any proteins derived from human or                                                                                                       Bovine serum albumin and aprotinin
               Culture                                                                                                                                                                                                                                  with no animal or human derived materials added during the                                                                                                but does not contain any materials derived from
                                       animal proteins, such as albumin, are added during the                                     processes                                                           animal sources
                                                                                                                                                                                                                                                                manufacturing process or to the final product.                                                                                                                 human or animal sources.
                                       purification and formulation processes of Kogenate FS

                                      Sucrose: 0.9-1.3% (250 IU, 500 IU, 1,000 IU); 0.9-1.2%                                                                                                                                                             The reconstituted product contains the following excipients
    Stabilizer in Final              (2,000 IU, 3,000 IU) Glycine: 21–25 mg/mL (250 IU, 500                   2.2% glycine, 1% sucrose, 30 mM sodium chloride,                     18 mg/mL sodium chloride, 1.5 mg/mL L-histidine, 3 mg/                  per mL: 18 mg sodium chloride, 5.4 mg sucrose, 5.4 mg
                                                                                                                                                                                                                                                                                                                                       Human albumin, calcium, polyethylene glycol, sodium,
                                    IU, 1,000 IU); 20-24 mg/mL (2,000 IU, 3,000 IU) Histidine:                2.5 mM calcium chloride, 20 mM histidine and 80                       mL sucrose, 0.1 mg/mL polysorbate 80, 0.055 mg/mL                    L-arginine hydrochloride, 0.3 mg calcium chloride dihydrate,                                                                                                                      Sucrose
         Formulation                                                                                                                                                                                                                                                                                                                               histidine, polysorbate 80.
                                     18–23 mmol/L(250 IU, 500 IU, 1,000 IU); 17–22 mmol/L                                    ppm polysorbate 80.                                     L-methionine, 0.25 mg/mL calcium chloride dihydrate                      1.2 mg poloxamer 188, and 1.2 mg sodium citrate
                                                        (2,000 IU, 3,000 IU)                                                                                                                                                                                                       dihydrate.

                                     The purification process includes a solvent/detergent virus                                                                                                                                                                                                                                                                                                                        The purification process uses a series of
                                                                                                                                                                                    The production process includes two dedicated viral                    The active substance is concentrated and purified by a
                                      inactivation step in addition to the use of the purification             The production process incorporates two dedicated                                                                                                                                                                                                                                                   chromatography steps, one of which is based on
              Viral Safety                                                                                                                                                          clearance steps:                                                      series of chromatography steps, which also includes two
                                       methods of ion exchange chromatography, monoclonal                  viral clearance steps: (1) a detergent treatment step for                                                                                                                                                                                                                                             affinity chromatography using a patented synthetic
                                                                                                                                                                                                                                                          dedicated viral clearance steps: solvent/detergent (S/D)                                  Immunoaffinity chromatography
               Processes             antibody immunoaffinity chromatography, along with other                inactivation and (2) a 20 nanometer filtration step for                    •   A detergent treatment step for inactivation                                                                                                                                                                            peptide affinity ligand. The process also includes a
                                                                                                                                                                                                                                                           treatment for virus inactivation and 20 nm nanofiltration
                                       chromatographic steps designed to purify recombinant                  removal of viruses and potential protein aggregates.                     •   A 20 nm filtration step for removal of viruses                                                                                                                                                                          solvent-detergent viral inactivation step and a virus-
                                                                                                                                                                                                                                                                             for removal of viruses.
                                          factor VIII and remove contaminating substances.                                                                                                                                                                                                                                                                                                                                   retaining nanofiltration step.

                                                                                                                         0 to
2018 Product Reference Charts - Protein Therapies - BDI Pharma, LLC
www.alphanate.com/hcp

             ©2017 Grifols   All rights reserved   December 2017   US/A8/1215/0122(1)
Plasma-Derived Factor VIII                                                                                                                                                                                                                                                                                                                                                                    800.948.9834                    |          www.bdipharma.com

  Product Specifics                                                  Alphanate®                                                                             HEMOFIL M                                                                         Humate-P®                                                                                    KOATE®                                                                            Monoclate-P®
                                                                           Grifols                                                                                 Shire                                                                       CSL Behring                                                                                   Kedrion                                                                             CSL Behring

                                         Alphanate is indicated for:                                                                                                                                                     Prevention and treatment of bleeding in adult patients
                                           • Control and prevention of bleeding episodes and                                                                                                                           with Hemophilia A. Also indicated for adult and pediatric
                                               perioperative management in adult and pediatric                                                                                                                           patients with von Willebrand disease for (1) treatment
                                               patients with Factor VIII (FVIII) deficiency due to                                  The use of HEMOFIL M is indicated in hemophilia A                                    of spontaneous and trauma-induced bleeding episodes                                KOĀTE is a human plasma-derived antihemophilic factor
                                               hemophilia A.                                                                      (classical hemophilia) for the prevention and control of                             and (2) prevention of excessive bleeding during and after
                                                                                                                                                                                                                                                                                                             indicated for the control and prevention of bleeding
               Indications                 • Surgical and/or invasive procedures in adult and                                                    hemorrhagic episodes.                                                   surgery. This applies to patients with severe VWD as                                                                                                                                           Treatment of hemophilia A
                                                                                                                                                                                                                                                                                                           episodes or in order to perform emergency and elective
                                               pediatric patients with von Willebrand Disease (VWD)                                                                                                                    well as patients with mild to moderate VWD where use of
                                               in whom desmopressin (DDAVP) is either ineffective                                                                                                                       desmopressin is known or suspected to be inadequate.                                        surgery in patients with hemophilia A.
                                                                                                                                 HEMOFIL M is not indicated in von Willebrand’s disease.
                                               or contraindicated.
                                         It is not indicated for patients with severe VWD (Type 3)                                                                                                                     Humate-P is not indicated for the prophylaxis treatment of
                                         undergoing major surgery.                                                                                                                                                            spontaneous bleeding episodes in VWD.

                                              Alphanate is contraindicated in patients who have                                 HEMOFIL M is contraindicated in patients with a known                                 Individuals who have had an anaphylactic or severe systemic                           Do not use in patients who have known hypersensitivity
                                            manifested life-threatening immediate hypersensitivity
   Contraindications                        reactions, including anaphylaxis, to the product or its
                                                                                                                               hypersensitivity to the active substance, to excipients, or to                           response to antihemophilic factor or von Willebrand factor                             reactions, including anaphylaxis, to KOĀTE or its                                               Known hypersensitivity to mouse protein
                                                                 components.                                                                          mouse proteins.                                                                        preparations.                                                                        components.

                                           Alphanate is manufactured using source plasma from
                                          qualified adult donors who are thoroughly screened and
                                        tested. Using the National Donor Deferral Registry (NDDR),
                                        previously rejected applicants will not be allowed to donate.
                                         Each source plasma donation undergoes a minimum 60-
                                                                                                                                                                                                                                                                                                                 KOĀTE is made from human plasma donated at
        Source Plasma                   day inventory hold. When the inventory hold period is over,                                                              Human                                                       Cold insoluble fraction of pooled human plasma                                                                                                                                              Pooled human plasma
                                                                                                                                                                                                                                                                                                                            centers within the US.
                                         each donation is computer verified. Plasma is then pooled
                                          for production and tested again for HIV, HAV, HBV, HCV
                                         and PVB19. Repeating the viral testing for both individual
                                         donations and the production pools guarantees that each
                                                plasma donation has met all safety controls.

                                                                                                                                                                                                                                                                                                      The KOĀTE manufacturing process includes two dedicated steps
                                                                                                                                                                                                                                                                                                       with virus inactivation capacity. The solvent/detergent treatment
                                                                                                                                                                                                                                                                                                         step has the capacity to inactivate enveloped viruses (such
                                                                                                                                                                                                                                                                                                         as HIV, HCV, HBV, and WNV). Heat treatment at 80°C for 72
                                       Affinity Chromatography, 3.5% PEG precipitation, salt/glycine                                                                                                                                                                                                    hours has the capacity to inactivate enveloped viruses (such as
                                       precipitation, and lyophilization. Solvent/Detergent Treatment                                                                                                                     Cryoprecipitation and Al(OH)3 adsorption, glycine
                                                                                                                                              Immunoaffinity Chromatography,                                                                                                                             HIV and HCV) as well as nonenveloped viruses (such as HAV                                    Monoclonal Antibody Immunoaffinity Chromatography.
              Viral Safety             and Heat Treatment at 80° for 72 hrs. Manufacturing process                                                                                                                   precipitation and NaCl precipitation, studied in combination.
                                                                                                                                        Ion Exchange Chromatography, Nanofiltration.                                                                                                                     and B19V). The polyethylene glycol (PEG) precipitation/depth                                   Pasteurization by heating at 60°C for 10 hours in
               Processes                  includes steps that provide a reasonable assurance that                                                                                                                     Heat treatment in aqueous solution at 60°C for 10 hours.
                                                                                                                                                Solvent/Detergent Treatment                                                                                                                             filtration step has the capacity to remove both enveloped and                                                   aqueous solution
                                        low levels of a vCJD model agent, if present in the starting                                                                                                                                         Lyophilization
                                                        material, would be removed.                                                                                                                                                                                                                     nonenveloped viruses. The manufacturing process has been
                                                                                                                                                                                                                                                                                                        shown to decrease TSE infectivity of that experimental model
                                                                                                                                                                                                                                                                                                         agent (a total of 5.1 log10 reduction), providing reasonable
                                                                                                                                                                                                                                                                                                      assurance that low levels of vCJD/CJD agent infectivity, if present
                                                                                                                                                                                                                                                                                                                   in the starting material, would be removed.

                                      17.9 ± 9.6 hours in hemophilia A patients 7.67 ± 3.3 hours for
                                                                                                                                                                                                                          Hemophilia A: Mean half-life of 12.2 hours (8.4-17.4)
     Product Half Life                VWF:RCo in VWD patients 21.6 ± 7.8 hours for FVIII:C in VWD                                                          14.8 ± 3.0 hours                                                                                                                                             Mean biologic half-life was 16.1 hours.                                                        Mean half-life of 17.5 hours
                                                                                                                                                                                                                                    VWF:RCo 11 hours (3.5-33.6)
                                                               patients

                                      96.7 ± 14.5% (mean ± SD) hours in hemophilia A patients 3.3                                                                                                                                                                                                          Each vial of KOĀTE is labeled with the actual Factor VIII
   Product Recovery
                                       ± 1.5 (IU/dL)/(IU/kg) for VWF:RCo in VWD patients 2.1 ± 0.6                                Approximately 2.0 iu/dL per infused iu/kg body weight                                                        2 IU/dL/IU/kg                                             potency in international units (IU). Calculation of the required                                                      1.9 IU/dL/IU/kg
        Percentage                               (IU/dL)/(IU/kg) for FVIII:C in VWD patients                                                                                                                                                                                                                   dose of Factor VIII activity is approximately 2%

    Presence of von
                                                                             Yes                                                                                    No                                                              Yes, VWF:Rco to FVIII ratio: 2.4:1                                          Yes, but NOT indicated for Von Willebrand Disease                                                    Reduced amounts of VWF:Ag
   Willebrand Factor

                                                                                                                                                                                                                                                                                                                                                                                                    Store in refrigerator, 2-8°C (36-46°F) through expiration
                                                                                                                                                                                                                                                                                                       Store the KOĀTE package at 2 to 8°C (36 to 46°F). KOĀTE may                                 date on label. Within this period, Monoclate-P® may be
               Storage Room temperature storage for 36 months, up to expiration date                                         Refrigeration 2° - 8°C (36° - 46°F) or room temperature, not to                          When stored up to 25°C (up to 77°F), Humate-P® is stable
                                                                                                                                                                                                                                                                                                        be stored at room temperature (up to 25°C or 77°F) for up to                               stored at room temperature, not to exceed 25°C (77°F),
          Requirements          printed ≤ 25 °C (77 °F). Do not Freeze.                                                      exceed 30°C or 86°F until expiration date noted on package.                               up to the expiration printed on the label. Do not freeze.
                                                                                                                                                                                                                                                                                                                                6 months                                                            for up to 6 months. Avoid freezing which may damage
                                                                                                                                                                                                                                                                                                                                                                                                                     container for the diluent.

Shelf Life from Date                    Stable for three years, up to the expiration date printed on its
                                                                                                                                                                                                                                                                                                       Approximately 24 months. Do not use KOĀTE after the labeled
                                       label, provided that the storage temperature does not exceed                                                            30 months                                                                        36 months                                                                                                                                                                         24 months
    of Manufacture                                               25°C (77°F).
                                                                                                                                                                                                                                                                                                                            expiration date.

                                                                                                                                                                                                                       600 IU VWF:Rco and 250 IU FVIII/vial - 5 mL, 1,200 IU
       How Supplied /                                       5mL for 250 and 500 IU                                                                                                                                                                                                                                                                                                                      250 IU - 2.5 mL, 500 IU - 5 mL, 1,000 IU - 10 mL,
                                                                                                                                                                  10 mL                                               VWF:Rco and 500 IU FVIII/vial - 10 mL, 2,400 IU VWF:Rco                            250 IU - 5mL, 500IU - 5mL and 1000mL 10IU with Mix2Vial
       Diluent Volume                                   10mL for 1000, 1500, and 2000 IU                                                                                                                                                                                                                                                                                                                                1,500 IU - 10 mL
                                                                                                                                                                                                                                  and 1000 IU FVIII/vial - 15 mL

DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced                    on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions
from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at 1-800-948-9834.           The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information. ©2018 BDI Pharma, LLC. All rights reserved.
Rebinyn® elevates factor levels above baseline levels1,a

                                                                                                                          +94%                                                FIX levels
                                                                                                                                                                              achieved                                17                    %            FIX levels
                                                                                                                                                                                                                                                         sustained
                                                                                                                                 immediately after an infusion1,b                                                                     after 7 days1,a
                                                                                                                    b
                                                                                                                        Based upon a 2.34% increase in factor levels per IU/kg infused                     a
                                                                                                                                                                                                               Based upon a single initial dose of Rebinyn® 40 IU/kg in
                                                                                                                        in adults.                                                                             6 adults (mean FIX activity 16.8%), 3 adolescents (mean FIX
                                                                                                                                                                                                               activity 14.6%), 13 children ages 7 to 12 (mean FIX activity
                                                                                                                                                                                                               10.9%), and 12 children ages 0-6 (mean FIX activity 8.4%)
                                                                                                                                                                                                               upon enrollment in the phase 3 trials using one-stage assay
                                                                                                                                                                                                               with product-specific standard.

                                                                                                                                       With a single dose of Rebinyn® 40 IU/kg in adults with ≤2% factor levels1,a

Clayton, 34 years old, is a pilot who hikes and camps
in his spare time. Clayton lives with hemophilia B.

Image of hemophilia B patient shown is for illustrative purposes only.

INDICATIONS AND USAGE                                            Warnings and Precautions                                 • The use of Factor IX-containing products                                              Adverse Reactions
Rebinyn®, Coagulation Factor IX                                  • Hypersensitivity reactions, including                    has been associated with thrombotic                                                   • The most common adverse reactions
(Recombinant), GlycoPEGylated, is a                                anaphylaxis, may occur. Signs may include                complications. Monitor for thrombotic and                                               reported in clinical trials (≥1%) were itching
recombinant DNA derived coagulation Factor                         angioedema, chest tightness, difficulty                  consumptive coagulopathy when                                                           and injection site reactions.
IX concentrate indicated for use in adults and                     breathing, wheezing, urticaria, and itching.             administering Rebinyn® to patients with liver                                         • Animals administered repeat doses of
children with hemophilia B for on demand                           Discontinue Rebinyn® if allergic or                      disease, post-operatively, to newborn infants,                                          Rebinyn® showed accumulation of PEG in the
treatment and control of bleeding episodes                         anaphylactic-type reactions occur and initiate           or to patients at risk of thrombosis or                                                 choroid plexus. The potential clinical
and perioperative management of bleeding.                          appropriate treatment.                                   disseminated intravascular coagulation (DIC).                                           implications of these animal findings are
Limitations of Use: Rebinyn® is not indicated                    • Development of neutralizing antibodies                 • Nephrotic syndrome has been reported                                                    unknown.
for routine prophylaxis or for immune                              (inhibitors) to Factor IX may occur. Monitor             following immune tolerance induction
                                                                                                                            therapy with Factor IX products in                                                    Please see the Rebinyn® Prescribing
tolerance induction in patients with                               patients for development of factor IX
                                                                                                                            hemophilia B patients with Factor IX                                                  Information in the pocket.
hemophilia B.                                                      inhibitors if bleeding is not controlled with                                                                                                  Reference: 1. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc;
                                                                   the recommended dose of Rebinyn® or if                   inhibitors, often with a history of allergic                                          May 2017.
IMPORTANT SAFETY INFORMATION                                                                                                reactions to Factor IX. The safety and efficacy
                                                                   expected Factor IX activity plasma levels are
Contraindications                                                  not attained. Factor IX activity assay results           of using Rebinyn® for immune tolerance
• Rebinyn® is contraindicated in patients with                     may vary with the type of activated partial              induction have not been established.                                                     Learn more at rebinynpro.com
  a known hypersensitivity to Rebinyn® or its                      thromboplastin time reagent used.
  components, including hamster proteins.

                                                                                                                          Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, New Jersey 08536 U.S.A.
                                                                                                                          Rebinyn® is a registered trademark of Novo Nordisk Health Care AG.
                                                                                                                          Novo Nordisk is a registered trademark of Novo Nordisk A/S.

                                                                                                                          © 2018 Novo Nordisk     All rights reserved.   USA17BIO04152   January 2018
Recombinant Factor IX                                                                                                                                                                                                                                                                                                                                                                          800.948.9834                    |          www.bdipharma.com

  Product Specifics                                          ALPROLIX®                                                                 BeneFIX®                                                              IDELVION®                                                             IXINITY®                                                                    Rebinyn®                                                                 RIXUBIS®
                                                                 Bioverativ                                                                Pfizer                                                             CSL Behring                                                             Aptevo                                                                   Novo Nordisk                                                                  Shire

                                         ALPROLIX [Coagulation Factor IX (Recombinant),
                                         Fc Fusion Protein] is a recombinant DNA derived,                                                                                             Children and adults with hemophilia B (congenital                                                                                               Adults and children with hemophilia B for:
                                         coagulation factor IX concentrate indicated in adults                                                                                        Factor IX deficiency) for:                                                                                                                             •    On-demand treatment and control of bleeding
                                         and children with Hemophilia B for:                                      BeneFIX, Coagulation Factor IX (Recombinant),                                                                                                                                                                                  episodes
                                                                                                                                                                                        • On-demand control and prevention of                                                                                                                                                                                    Indicated in adults and children with hemophilia B
                                                                                                                    is indicated for the control and prevention of                                                                                                                                                                          •    Perioperative management of bleeding
                                           • On-demand treatment and control of bleeding                                                                                                   bleeding episodes                                                Adults and children at least 12 years of age with                                                                                                     for: Control and prevention of bleeding episodes,
                                                                                                               hemorrhagic episodes in adult and pediatric patients
               Indications                    episodes
                                                                                                                with hemophilia B (congenital factor IX deficiency
                                                                                                                                                                                        • Perioperative management of bleeding                             hemophilia B for control and prevention of bleeding                        Limitations of Use:                                                       perioperative management, and routine prophylaxis.
                                           • Perioperative management of bleeding                                                                                                       • Routine prophylaxis to prevent or reduce the                       episodes, and for perioperative management                               Rebinyn® is not indicated for routine prophylaxis in                        RIXUBIS is not indicated for induction of immune
                                                                                                                 or Christmas disease), including management of
                                           • Routine prophylaxis to reduce the frequency of                                                                                                frequency of bleeding episodes                                                                                                             the treatment of patients with hemophilia B.                                      tolerance in patients with hemophilia B.
                                                                                                                           hemostasis in surgical settings.
                                              bleeding episodes.                                                                                                                      IDELVION is not indicated for immune tolerance                                                                                                  Rebinyn® is not indicated for immune tolerance
                                         ALPROLIX is not indicated for induction of immune                                                                                            induction in patients with hemophilia B.                                                                                                        induction in patients with hemophilia B
                                         tolerance in patients with Hemophilia B.

                                                                                                                        Because BeneFIX, Coagulation Factor IX
                                                                                                              (Recombinant), is produced in a Chinese hamster ovary
                                                                                                                 cell line, it may be contraindicated in patients with a                                                                                                                                                                                                                                                   Do not use in patients with: Known
                                        Do not use in individuals who have a known history of                                                                                              Do not use in patients who have had life-threatening                                                                                                Do not use in patients who have known
                                                                                                                 known history of hypersensitivity to hamster protein.                                                                                     Hypersensitivity to IXINITY or its excipients, including                                                                                                   hypersensitivity to RIXUBIS or its excipients
   Contraindications                    hypersensitivity reactions, including anaphylaxis, to the
                                                                                                                   BeneFIX is contraindicated in patients who have
                                                                                                                                                                                               hypersensitivity reactions to IDELVION or its
                                                                                                                                                                                                                                                                              hamster protein
                                                                                                                                                                                                                                                                                                                                            hypersensitivity to Rebinyn® or its components,
                                                                                                                                                                                                                                                                                                                                                                                                                        including hamster protein. Disseminated
                                                        product or its excipients.                                                                                                              components, including hamster proteins.                                                                                                               including hamster proteins
                                                                                                               manifested life-threatening, immediate hypersensitivity                                                                                                                                                                                                                                               intravascular coagulation. Signs of fibrinolysis
                                                                                                                reactions, including anaphylaxis, to the product or its
                                                                                                                                       components.

                                             To enhance viral safety, the purification process                 Purified by a chromatography purification process that                                                                                         Purified by a chromatography purification process that
                                             incorporates a nanofiltration step and a column                  does not require a monoclonal antibody step and yields                                                                                       includes three validated steps for virus inactivation and                   The production process includes two dedicated viral
              Viral Safety                                                                                                                                                           The manufacturing process incorporates three validated                                                                                           clearance steps:
                                      chromatography purification step that have been validated               a high-purity, active product. The process also includes a                                                                                 removal - solvent/detergent treatment, a chromatographic                                                                                                                 15 nm Nanofiltration.
                                                                                                                                                                                       virus clearance steps, including virus inactivation by
               Processes                for viral clearance. The content of activated Factor IX Fc           membrane nanofiltration step that has the ability to retain                                                                                  step, and nanofiltration. The manufacturing process also                        •       A detergent treatment step for inactivation                                  Solvent/Detergent Treatment.
                                                                                                                                                                                    solvent/detergent treatment and virus removal by filtration.
                                       fusion protein (FIXaFc) is limited to ≤0.035 mole percent               molecules with apparent molecular weights >70,000                                                                                        includes a validated step to reduce the presence of CHO                         •       A 20 nm filtration step for removal of viruses
                                                               FIXaFc/FIXFc.                                        (such as large proteins and viral particles).                                                                                                    proteins in the final drug product.

                                                                50 IU/kg        100 IU/kg
                                                                                                                                                                                                   0 to 15 years): 18.8 ± 5.4h
                                                                                                                                                                                                  6 to
www.alphanate.com/hcp

             ©2017 Grifols   All rights reserved   December 2017   US/A8/1215/0122(1)
FVIII / vWF Complex Concentrates (Indicated to treat von Willebrand Disease)                                                                                                                                                                                                                                                                                                          800.948.9834                    |          www.bdipharma.com

  Product Specifics                                                             Alphanate®                                                                                                  Humate-P®                                                                                      VONVENDI®                                                                                                           wilate®
                                                                                     Grifols                                                                                                 CSL Behring                                                                                          Shire                                                                                                     Octapharma

                                         Alphanate is indicated for:                                                                                 Prevention and treatment of bleeding in adult patients with Hemophilia
                                           • Control and prevention of bleeding episodes and perioperative                                            A. Also indicated for adult and pediatric patients with von Willebrand                                                                                                                                           WILATE is indicated in children and adults with von Willebrand
                                             management in adult and pediatric patients with Factor VIII (FVIII)                                     disease for (1) treatment of spontaneous and trauma-induced bleeding                                                                                                                                              disease for:
                                             deficiency due to hemophilia A.                                                                            episodes and (2) prevention of excessive bleeding during and after                               VONVENDI is a recombinant von Willebrand factor (VWF) indicated
                                                                                                                                                      surgery. This applies to patients with severe VWD as well as patients                                                                                                                                              • On-demand treatment and control of bleeding episodes
               Indications                 • Surgical and/or invasive procedures in adult and pediatric patients                                                                                                                                       for on-demand treatment and control of bleeding episodes in adults
                                                                                                                                                       with mild to moderate VWD where use of desmopressin is known or                                                                                                                                                   • Perioperative management of bleeding
                                             with von Willebrand Disease (VWD) in whom desmopressin (DDAVP)                                                                                                                                                        diagnosed with von Willebrand disease.
                                             is either ineffective or contraindicated.                                                                                     suspected to be inadequate.                                                                                                                                                                 Limitations of Use: WILATE is not indicated for the treatment of
                                                                                                                                                     Humate-P is not indicated for the prophylaxis treatment of spontaneous                                                                                                                                            hemophilia A.
                                         It is not indicated for patients with severe VWD (Type 3) undergoing
                                         major surgery.                                                                                                                   bleeding episodes in VWD.

                                                                                                                                                                                                                                                        Do not use in patients who have had life-threatening hypersensitivity                                          WILATE is contraindicated in patients with known hypersensitivity
                                       Alphanate is contraindicated in patients who have manifested life-threatening
                                                                                                                                                     Individuals who have had an anaphylactic or severe systemic response to                          reactions to VONVENDI or its components (mannitol, trehalose, sodium                                              reactions, including anaphylactic or severe systemic reactions, to
   Contraindications                   immediate hypersensitivity reactions, including anaphylaxis, to the product or
                                                                                                                                                             antihemophilic factor or von Willebrand factor preparations.                             chloride, histidine, Tris, calcium chloride, polysorbate 80, and hamster or                                     human plasma-derived products, any ingredient in the formulation or
                                                                      its components.
                                                                                                                                                                                                                                                                                      mouse proteins).                                                                                     components of the container

              Viral Safety               1.2 average ratio. Ratio of VWF:RCo to FVIII varies by lot, so check IU
                                                                                                                                                                                                                                                     Administer VONVENDI with recombinant factor VIII if required, to control
                                      VWF:RCo/vial to ensure accurate dosing. Actual FVIII and VWF:RCo potency is                                                    Cold insoluble fraction of pooled human plasma                                                                                                                                                                          The VWF:RCo to FVIII:C ratio is 1:1.
               Processes                                                                                                                                                                                                                                         bleeding. Dosing should be at a ratio of 1.3:1
                                                     listed on vial label & folding carton for each lot.

                                                Affinity Chromatography, 3.5% PEG precipitation, salt/glycine
                                                                                                                                                     Cryoprecipitation and Al(OH)3 adsorption, glycine precipitation and NaCl                                                                                                                                                            Ion-exchange chromatography,
                                           precipitation, and lyophilization. Solvent/Detergent Treatment and Heat                                                                                                                                     VONVENDI is produced and formulated without the addition of any
                                                                                                                                                                       precipitation, studied in combination.                                                                                                                                                      Solvent/detergent (S/D) treatment, and terminal dry-heat (TDH) treatment
     Product Half Life                     Treatment at 80° for 72 hrs. Manufacturing process includes steps that
                                                                                                                                                            Heat treatment in aqueous solution at 60°C for 10 hours
                                                                                                                                                                                                                                                      exogenous raw materials of human or animal origin in the cell culture,
                                                                                                                                                                                                                                                                                                                                                                    of the lyophilized product in final container [at +100°C (212°F) for 120
                                           provide a reasonable assurance that low levels of a vCJD model agent,                                                                                                                                                purification, or formulation of the final product.
                                                                                                                                                                                    Lyophilization                                                                                                                                                                        minutes at a specified residual moisture level of 0.7 - 1.6%].
                                                    if present in the starting material, would be removed.

   Product Recovery                      17.9 ± 9.6 hours in hemophilia A patients 7.67 ± 3.3 hours for VWF:RCo                                                   Hemophilia A: Mean half-life of 12.2 hours (8.4-17.4)
                                                                                                                                                                                                                                                                Mean half-life of 19.3 hours when infused with ADVATE                                                    15.8 ± 11.0 hours for VWF:RCo, and 19.6 ± 6.9 hours for FVIII:C.
        Percentage                             in VWD patients 21.6 ± 7.8 hours for FVIII:C in VWD patients                                                                 VWF:RCo 11 hours (3.5-33.6)

         Manufacturing                96.7 ± 14.5% (mean ± SD) hours in hemophilia A patients 3.3 ± 1.5 (IU/dL)/
                                       (IU/kg) for VWF:RCo in VWD patients 2.1 ± 0.6 (IU/dL)/(IU/kg) for FVIII:C in                                                                         2 IU/dL/IU/kg                                                                                           1.7                                                            1.9 ± 0.4 % per IU/kg for VWF:RCo, and 2.2 ± 0.5 % per IU/kg for FVIII:C.
               Method                                              VWD patients

                                                                                                                                                                                                                                                    Store VONVENDI refrigerated at 2°C to 8°C (36°F to 46°F) in the original
                                                                                                                                                                                                                                                       box and protect from extreme exposure to light. Do not freeze. May
               Storage                                                                                                                                                                                                                                store at room temperature up to 30°C (86°F) for a period of up to 12
                                           Room temperature storage for 36 months, up to expiration date printed                                        When stored up to 25°C (up to 77°F), Humate-P® is stable up to the
                                                                                                                                                                                                                                                    months not to exceed the expiration date. Record on the carton the date                                                          Do not freeze. Do not use after expiration date.
          Requirements                                       ≤ 25°C (77 °F). Do not freeze.                                                                       expiration printed on the label. Do not freeze.
                                                                                                                                                                                                                                                     VONVENDI is removed from refrigeration. Do not return to refrigerated
                                                                                                                                                                                                                                                     temperature after storing at room temperature. Do not use beyond the
                                                                                                                                                                                                                                                          expiration date printed on the VONVENDI vial label or carton.

Shelf Life from Date                                                                                                                                                                                                                                                                                                                                              36 months at +2°C to +8°C (36°F to 46°F) protected from light from the
                                       Stable for three years, up to the expiration date printed on its label, provided                                                                                                                              Use up to the expiration date on the label – may store for 12 months at
                                                                                                                                                                                              36 months                                                                                                                                                           date of manufacture. Within this period, Wilate may be stored for a period
    of Manufacture                              that the storage temperature does not exceed 25°C (77°F).                                                                                                                                                        room temperature not to exceed 30°C (86°F).
                                                                                                                                                                                                                                                                                                                                                                   of up to 6 months at room temperature (maximum of +25°C or 77°F).

       How Supplied /                                                 5mL for 250 and 500 IU                                                       600 IU VWF:Rco and 250 IU FVIII/vial - 5 mL, 1,200 IU VWF:Rco and 500 IU                                                                                                                                                  500 IU VWF:RCo and 500 IU FVIII:C activities in 5 mL, and
                                                                                                                                                                                                                                                                        450–850 IU in 5 mL, 900–1700 IU in 10 mL
       Diluent Volume                                             10mL for 1000, 1500, and 2000 IU                                                     FVIII/vial - 10 mL, 2,400 IU VWF:Rco and 1000 IU FVIII/vial - 15 mL                                                                                                                                                   1000 IU VWF:RCo and 1000 IU FVIII:C activities in 10 mL

DISCLAIMER: Information provided herein is a summary of available information only. This summary has been compiled by BDI Pharma and does not represent a clinical comparison conducted by any manufacturer referenced            on any of these pages. It is to be used as a general reference tool only and is not intended for use as a guideline for clinical evaluations. Such evaluations (including but not limited to initial and/or subsequent dosing, conversions
from specific product brands, etc.) should utilize a thorough review of appropriate clinical data. For a copy of a package insert or to request any additional information at our disposal, please contact us at 1-800-948-9834.   The possibility of error (typographical or otherwise) exists in this summary. BDI Pharma expressly disclaims any and all warranties and liability arising out of or related to this information. ©2018 BDI Pharma, LLC. All rights reserved.
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