2018 Product Reference Charts - Protein Therapies - BDI Pharma, LLC
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
BDI Pharma, LLC 2018 Product Reference Charts Protein Therapies
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)
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.
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
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.
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
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
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
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 2018Recombinant 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 towww.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.You can also read
