Clinically Isolated Syndrome (CIS) - An introduction to - Betaseron

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Clinically Isolated Syndrome (CIS) - An introduction to - Betaseron
An introduction to
Clinically Isolated Syndrome (CIS)

                                                               If you’re facing a diagnosis of
                                                               clinically isolated syndrome
                                                               (or early multiple sclerosis),
                                                               you probably have questions
                                                               and want to know as much as
                                                               you can.
                                                               Your doctor is your primary
                                                               resource for information, but
                                                               this brochure can help you get
                                                               the conversation started.

                                                               Models used for illustrative purposes only.

INDICATIONS
BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms
of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease,
and active secondary progressive disease, in adults.

IMPORTANT SAFETY INFORMATION
Do not take BETASERON (interferon beta-1b) if you are allergic to interferon beta-1b, to
another interferon beta, to human albumin, or mannitol.

Please see Important Safety Information throughout and Important Facts About
BETASERON® on pages 14 and 15. For BETACONNECT™ Instructions for Use, please visit
www.betaconnectifu.com, and for myBETAapp™ Instructions for Use, please visit
www.mybetaappifu.com.
Clinically Isolated Syndrome (CIS) - An introduction to - Betaseron
Understanding
Clinically Isolated Syndrome
What is clinically isolated syndrome (CIS)?                                                          What happens during a CIS episode?
CIS is a first episode of neurologic symptoms caused by inflammation in the central nervous            The location where the damage to the myelin occurs in the central nervous system will determine
system. The episode must last for at least 24 hours and is considered a relapsing form of multiple   what symptoms you might experience during a CIS episode. Damage can be in the spinal cord,
sclerosis (MS). In fact, CIS is often referred to as early MS.                                       optic nerve, or brain.

Inflammation in the central nervous system happens when your body’s immune system                     When damage to the myelin occurs in the spinal cord, the onset of symptoms may be sudden,
mistakenly attacks and damages the protective coating around your nerves, which is called myelin.    developing over 1 to 2 hours, or more gradual, happening over a week or more. Symptoms can
This damage prevents your nerves from sending signals to your brain, spinal cord, and other parts    include muscle weakness; abnormal sensations in the toes and feet; numbness or tingling in
of your body the way they should.                                                                    the arms, legs, or face; bladder and bowel problems; or Lhermitte’s sign (an electric shock-like
                                                                                                     sensation when the neck is moved that is felt down the spine, and often into the arms and legs).

How is CIS diagnosed?                                                                                When damage to the myelin occurs in the optic nerve, the onset of symptoms may be sudden
                                                                                                     or develop over a few hours. Symptoms can include blurred vision or loss of sight, pain behind the
To make a diagnosis of CIS, your doctor—most likely a neurologist— will perform a magnetic           eyeball, impaired color or blind spots surrounded by an area of normal vision, or other
resonance imaging (MRI) scan to look for signs of inflammation and loss of myelin in the central      eye problems.
nervous system.
                                                                                                     When damage to the myelin occurs in the brain, the symptoms may include nausea, vomiting,
Your doctor may also perform:                                                                        double vision, dizziness, hearing loss, or problems with balance or walking.
        • A physical examination, including a neurologic examination

        • A complete medical history with specific questions about your symptoms and
          how long you have had them                                                                                      Abbreviations used in this brochure
        • Lab tests to rule out other possible causes of your symptoms                                                            CIS–clinically isolated syndrome
Occasionally, your doctor may perform a spinal tap to look at the fluid that surrounds your brain                                  DMT–disease-modifying therapy
and spinal cord.
                                                                                                                                  IV–intravenous
                                                                                                                                  MRI–magnetic resonance imaging
                                                                                                                                  MS–multiple sclerosis
                                                                                                                                  RRMS–relapsing-remitting multiple sclerosis

                                                                                                     IMPORTANT SAFETY INFORMATION (continued)
INDICATIONS                                                                                          BETASERON can cause serious side effects, including:
BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms             • Liver Problems Including Liver Failure: Symptoms of liver problems may include yellowing of
of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease,      your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting, bruising easily
and active secondary progressive disease, in adults.                                                   or bleeding problems. Your healthcare provider will do blood tests to check for these problems
                                                                                                       while you take BETASERON.

                                                                                                     • Serious Allergic Reactions: Serious allergic reactions can happen quickly and may happen after
                                                                                                       your first dose of BETASERON or after you have taken BETASERON many times. Symptoms may
                          Please see Important Safety Information throughout and Important             include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or
                          Facts About BETASERON® on pages 14 and 15.                                   skin bumps.

2                                                                                                                                                                                                         3
Clinically Isolated Syndrome (CIS) - An introduction to - Betaseron
Understanding
Clinically Isolated Syndrome
How is CIS treated?                                                                                   What is the difference between CIS and RRMS?
In some cases, treatment with a high-dose oral or intravenous (IV) steroid is recommended to          Patients who experience CIS may or may not progress to other forms of relapsing MS. Relapsing-
reduce symptoms caused by inflammation. Disease-modifying therapy (DMT) is recommended                 remitting multiple sclerosis (RRMS) is the most common form of relapsing MS (85% of patients).
when CIS is considered more likely to progress. The goal of using DMT is to delay a second episode.
                                                                                                      In both CIS and RRMS, damage to the myelin interferes with the way the nerves send signals,
                                                                                                      which causes similar neurologic symptoms. The main difference, however, is that a person with CIS
Is DMT effective at delaying another episode?                                                          has only experienced a first episode, while someone with RRMS has had more than one.

Many large clinical studies have been conducted to prove that early treatment with DMT                With CIS, MRI results may show damage in the area of the brain that is responsible for the current
can delay another episode. Based on the results of these studies, the FDA has approved several        symptoms. In RRMS, the MRI scan may show multiple lesions (areas of damage) in different areas
medicines to treat patients in the CIS stage.                                                         of the brain. When the MRI scan shows that another episode occurred in the past, the person may
                                                                                                      be diagnosed with RRMS.
Early treatment with DMT may lessen the chance of the disease progressing because of
additional damage to nerve cells.
                                                                                                      Does CIS always progress?
                                                                                                      Not all people who experience CIS will go on to develop RRMS. An MRI scan is one of the most
                                                                                                      important tools used to identify the risk of the disease progressing.

                                                                                                      Studies have shown there is a high risk of developing RRMS when CIS is accompanied by brain
                                                                                                      lesions that are similar to those seen in other relapsing forms of MS. When this is the case, patients
                                                                                                      have a 60% to 80% chance of a second episode and diagnosis of RRMS within several years.

               Beginning treatment with disease-modifying therapy
                                                                                                      Where can I find more information?
                 as soon as possible is recommended for patients
                who have CIS and have MRI results consistent with
                      more advanced types of relapsing MS.                                                                                          Multiple Sclerosis Association of America
                                                                                                                                                    myMSAA.org

                                                                                                                                                    National Multiple Sclerosis Society
                                                                                                                                                    nationalMSsociety.org

                                                                                                      IMPORTANT SAFETY INFORMATION (continued)
                                                                                                      • Depression or Suicidal Thoughts: Call your healthcare provider right away if you have any of
                                                                                                        the following symptoms, especially if they are new, worse or worry you: thoughts about suicide
INDICATIONS                                                                                             or dying, new or worse depression (sinking feeling or sadness), new or worse anxiety (feeling
                                                                                                        uneasy, nervous or fearful for no reason), trouble sleeping (insomnia), acting aggressive, being
BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms                angry, or violent, acting on dangerous impulses, hallucinations, other unusual changes in
of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease,       behavior or mood.
and active secondary progressive disease, in adults.
                                                                                                      Other possible serious side effects with BETASERON include:
                                                                                                      • Heart Problems: BETASERON may worsen heart problems including congestive heart failure.
                                                                                                        Symptoms of heart problems may include swollen ankles, shortness of breath, decreased
                          Please see Important Safety Information throughout and Important              ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night, not
                          Facts About BETASERON® on pages 14 and 15.                                    being able to lay flat in bed.

4                                                                                                                                                                                                          5
Clinically Isolated Syndrome (CIS) - An introduction to - Betaseron
About BETASERON® (interferon beta-1b)
What is BETASERON?                                                                                      How can BETASERON® help? (continued)
BETASERON is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS),
to include clinically isolated syndrome, relapsing-remitting disease, and active secondary                 MRI data from the same 2-year study             Proven to reduce the number
progressive disease, in adults.                                                                            showed that BETASERON patients with             of newly active brain lesions
                                                                                                           the first symptoms of MS had fewer
BETASERON is similar to certain interferon proteins that are produced in the body and is given by
                                                                                                           newly active lesions at 2 years.

                                                                                                                                                                      56%
injection under your skin (subcutaneous injection) every other day.
                                                                                                           The exact relationship between MRI
                                                                                                           findings and the clinical status of
How can BETASERON help?
                                                                                                           patients is not known.
BETASERON has proven to be effective for patients who have clinically isolated syndrome.                                                                                 FEWER NEWLY
                                                                                                                                                                       ACTIVE LESIONS§
                                                                                                          §
                                                                                                              Newly active lesions=nonenhancing
                                                                                                              new or enlarging T2 lesions; new
     In a 2-year study, 292 patients with clinically           Proven to delay time to                        Gd-enhancing lesions.
     isolated syndrome* who started treatment
     early with BETASERON significantly reduced
                                                                  a second flare-up                                                                                  Newly active brain lesions
     their likelihood of having a second flare-up
                                                                                                                                                          With BETASERON              With placebo

                                                                    50%
     compared with 176 patients on placebo.†

                                                                                                                                                                 3.7
                                                                                                                                                             (292 patients)
                                                                                                                                                                                          8.5
                                                                                                                                                                                       (176 patients)
    *Patients included in the BENEFIT Study
      experienced a first neurological event
                                                                         LESS RISK‡
      suggestive of multiple sclerosis, which is also
      referred to as clinically isolated syndrome.
      Patients also had at least 2 lesions on a
      T2-weighted brain MRI scan that did not
      cause any symptoms.                                                                               Key safety information from study
    †
      A placebo looks exactly like the medicine but
      does not have any of the actual medicine in it.   Likelihood of a second flare-up within 2 years   • Most common adverse events found in the study: injection-site reactions, flu-like syndrome,
    ‡
      By proportional hazard ratio regression                                                             headache, asthenia, leukopenia, upper respiratory tract infection, paresthesia, fever, rash,
      adjusted for age/gender/steroids/                  With BETASERON           With placebo            and depression

                                                              28%                     45%
      T2 lesions/Gd lesions.
                                                                                                        • Five patients discontinued BETASERON treatment due to abnormal liver function test results,
                                                                                                          which did not last

INDICATIONS
BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms                IMPORTANT SAFETY INFORMATION (continued)
of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease,
and active secondary progressive disease, in adults.                                                    • Injection Site Problems: Serious skin reactions can happen in some people including areas
                                                                                                          of severe damage to skin and the tissue below the skin (necrosis). These reactions can happen
                                                                                                          anywhere you inject BETASERON. Symptoms of injection site problems may include swelling,
                                                                                                          redness, or pain at the injection site, fluid drainage from the injection site, breaks in your skin or
                                                                                                          blue-black skin discoloration. Change your injection site each time you inject BETASERON as it will
                                Please see Important Safety Information throughout and Important          lessen the chance of you having a serious skin reaction. Avoid injecting BETASERON into an area
                                Facts About BETASERON® on pages 14 and 15.                                of the skin that is sore, reddened, infected or has other problems.

6                                                                                                                                                                                                             7
Clinically Isolated Syndrome (CIS) - An introduction to - Betaseron
Your BETASERON® (interferon beta-1b)                                                                      Financial Support
Journey                                                                                                       A BETAPLUS® coverage specialist will help you understand your insurance benefits and navigate any
                                                                                                              issues. They can also help if you experience insurance changes. One-on-one support is always there
When you become a BETASERON patient, you get all the benefits of the BETAPLUS® Patient                         when you need it.
Support Program. BETAPLUS provides you with personalized one-on-one support throughout
your treatment.

Step       1       Your BETAPLUS coverage specialist will determine if you qualify for $0
                   copay assistance
                                                                                                                                            $0 copay
                                                                                                                                            Get up to $14,500 in copay assistance each calendar year,
                                                                                                                                            for as long as you’re on treatment.‡
Step       2       A BETA Nurse will schedule an appointment for your in-home injection training*

Step       3       Your BETASERON and BETACONNECT™ autoinjector will be delivered to your home
                                                                                                                                            BETA Bridge
Step       4       You will receive your comprehensive injection training kit and in-home training
                   from an MS-trained BETA Nurse. Your BETA Nurse will show you how to prepare
                                                                                                                                            At the start of your treatment, while your insurance benefits
                                                                                                                                            are being determined, BETA Bridge gets your therapy
                   your medication, inject BETASERON properly, and manage your injection site
                                                                                                                                            started right away. If you face an insurance gap, BETA Bridge
                   rotations. He or she will also provide you with tools to help you manage your
                                                                                                                                            can also keep your treatment going for up to 12 months
                   therapy and help pair your BETACONNECT™ with myBETAapp™
                                                                                                                                            at no cost.§

After your one-on-one injection training, your BETA Nurse will stay in touch to:
         • Guide you to the resources you need
         • Answer questions about BETASERON                                                               ‡
                                                                                                            Some limitations apply. Please visit betaseron.com/affordability or call 1-800-788-1467 for more information.
                                                                                                            Patients who are enrolled in any type of government insurance or reimbursement program are not eligible.
         • Support and help you stay motivated—on the phone, in person, via webcam, or by email             As a condition precedent of the copayment support provided under this program, eg, copay refunds, participating
                                                                                                            patients and pharmacies are obligated to inform insurance companies and third-party payors of any benefits
And, when you share your injection data with myBETAapp, your BETA Nurse can follow your                     they receive and the value of this program, as required by contract or otherwise. Void where prohibited by law,
progress and provide you with proactive support.† He or she can help to:                                    taxed, or restricted. Patients enrolled in Bayer’s Patient Assistance Program are not eligible. Offers are subject to
                                                                                                            change at any time.
         • See if you have missed any injections                                                          §
                                                                                                            If you have commercial insurance, you’re eligible.
         • Remind you to rotate injection sites properly
         • Identify your typical injection patterns
*Where state laws and insurance allow.
†
  Healthcare professionals must have BETACONNECT Navigator access, and a patient must enable sharing in
  myBETAapp for HCPs to obtain this information.

You can talk with a BETA Nurse any time, day or night, about BETASERON.

INDICATIONS                                                                                                   IMPORTANT SAFETY INFORMATION (continued)
BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms                      • Flu-like Symptoms: BETASERON can cause flu-like symptoms including fever, chills, tiredness,
of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease,               sweating, muscle aches when you first start to use it. These symptoms may decrease over
and active secondary progressive disease, in adults.                                                            time. Taking medicines for fever and pain relief on the days you are using BETASERON may help
                                                                                                                decrease these symptoms.

                                                                                                              • Seizures: Some people have had seizures while taking BETASERON, including people who
                                                                                                                have never had seizures before. It is not known if the seizures were related to MS, to BETASERON,
                             Please see Important Safety Information throughout and Important                   or to a combination of both. If you have a seizure after taking BETASERON call your healthcare
                             Facts About BETASERON® on pages 14 and 15.                                         provider right away.

8                                                                                                                                                                                                                                  9
Medication Meets Communication
                                                                                     1
    Your doctor makes treatment decisions based on the best information available. Give them the   4                      Track with myBETAapp™
    most accurate information you can—automatically.* Share your injection data with your BETA

                                                                                     2
                                                                                                                          By keeping track of your injection information, you can go

                                                   1            4
    Nurse and healthcare team every time you inject.* By providing an in-depth view of your injection
    information, you can have more meaningful discussions with your healthcare team.                                      back and review important aspects of your treatment.
                                                                                                                          With myBETAapp, you can see a snapshot of:
                                                                                                                                   • Your injection calendar (view past and

                 1          4                      2                                  3
                                                                                                                                     future injections)
                          TREAT                             TRACK                             SHARE                                • Injection sites (to help plan your rotation schedule)
                          Treat with                        Your real-time                    Give your
                                                                                                                          And, when you use the Wellness Tracker in myBETAapp,

                 2
                          BETASERON® using                  injection                         healthcare team
                          BETACONNECT™
                          and automatically
                          capture your
                                                   3        information
                                                            is sent to
                                                            myBETAapp™
                                                                                              the most accurate
                                                                                              information
                                                                                              you can,
                                                                                                                          you can track your everyday health by recording how
                                                                                                                          you feel—whenever, wherever—by answering a few
                                                                                                                          questions on your phone.
                          injection                         so you can track                  automatically*

                 3        information*                      your progress

                                                                                  Watch it in action.
                                                                                                                          Share with your BETA Nurse and
                                                                                                                          healthcare team§
                                                                                  betaconnectsystem.com
                                                                                                                          Keep the communication going by sharing your injection
             *
                 When using the BETACONNECT autoinjector, injection data is automatically transferred to                  information with myBETAapp. Your BETA Nurse can track
                 myBETAapp whenever the autoinjector is powered on and within range of a patient’s mobile                 your progress and help you when needed by:
                 device. myBETAapp must be open and running in order for data transfer to occur. Healthcare
                 professionals must have BETACONNECT Navigator access, and a patient must enable sharing                           • Seeing if you’ve missed any injections
                 in myBETAapp for HCPs to obtain this information. Please note: If a patient is not using                          • Reminding you to rotate your injection sites
                 BETACONNECT to administer injections, he/she can also record injections manually. Patients
                 are able to modify the details or delete injection data manually recorded in myBETAapp.                           • Identifying your typical injection patterns
                                                                                                                                                                                                    Models used for illustrative purposes only.
                                                                                                                          If you share your information, your doctor also has the
                                                                                                                          ability to follow your progress and provide you with
    Treat using the BETACONNECT™ autoinjector                                                                             support if needed.§
    Exclusively for BETASERON patients, the autoinjector provides:
            • Automatic needle insertion and retraction (once the injection is complete),
                                                                                                                      §
                                                                                                                          Healthcare professionals must have BETACONNECT Navigator access, and a patient must enable sharing in
              so you never need to see a needle during the injection process
                                                                                                                          myBETAapp for HCPs to obtain this information.
            • Built-in injection reminders, so you know when to take your next dose†
            • Customizable injection speed and depth‡
†
  Use the built-in reminder only as a backup. You still must take BETASERON on schedule and follow the instructions
  from your healthcare provider, even if you use the built-in reminder.
‡
  Before you change your injection speed or depth settings, talk with your healthcare provider or BETA Nurse.

    INDICATIONS
    BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms
    of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease,                     IMPORTANT SAFETY INFORMATION (continued)
    and active secondary progressive disease, in adults.
                                                                                                                          • Blood Problems: You may have a drop in the levels of infection-fighting white blood cells,
                                                                                                                            red blood cells, or cells that help you form blood clots. If drops in levels are severe, they can
                                                                                                                            lessen your ability to fight infections, make you feel tired or sluggish or cause you to bruise
                                                                                                                            or bleed easily.
                                   Please see Important Safety Information throughout and Important
                                   Facts About BETASERON® on pages 14 and 15.                                             • Pregnancy: Tell your doctor if you are pregnant or plan to become pregnant.

    10                                                                                                                                                                                                                                            11
Frequently Asked Questions                                                                               What Questions Can I Ask My Doctor?
 How is CIS diagnosed?                                                                                   If you have been diagnosed with CIS, you probably want to learn as much as you can. Asking
                                                                                                         questions about which treatment is right for you and learning about all your options, are important
 Your doctor will take a complete medical history and perform a physical examination and tests,          parts of managing your condition. Some questions you may want to ask include:
 including MRI.
                                                                                                                 • How will you manage my condition?
 If I have CIS will it definitely progress?                                                                       • How do DMT medicines work?
 Patients who experience CIS may or may not progress to other forms of relapsing MS. An MRI                      • How long will I need to be on treatment?
 scan is one of the most important tools used to identify the risk of disease progression.                       • Can I start a family if I am taking medicine?
                                                                                                                 • Are there any side effects that can happen from my medicine?
 Why should I begin treatment for CIS if I don’t know that it                                                    • Is there any way to lessen side effects?
 will progress?                                                                                                  • What other safety information should I know about?
 Studies have shown there is a high risk of developing RRMS when CIS is accompanied by brain             Using the lines below, write down other questions that you want to ask your doctor and bring them
 lesions that are similar to those seen in other relapsing forms of MS. Disease-modifying therapy is     with you to your next appointment.
 recommended in this situation, with the goal of delaying a second episode. Early treatment may
 lessen the chance of the disease progressing because of additional damage to nerve cells.

 Where can I find more information?
 To learn more, visit betaseron.com or ask your healthcare provider. You can also find information
 on the following websites: the Multiple Sclerosis Association of America (myMSAA.org) and the
 National Multiple Sclerosis Society (nationalMSsociety.org).

 What type of symptoms can I track in myBETAapp™?
 With the Wellness Tracker, the symptoms you can track include ability to walk, memory,
 coordination, bowel and bladder control, eating habits, and more.

 If I share my injection data in myBETAapp, who will see it?
 When you enable sharing, your BETA Nurse can see your information; however, you can also
 choose to share with your doctor.* If you do share your data with your BETA Nurse or doctor,
 your personal information will never be shared or sold.
*Healthcare professionals must have BETACONNECT Navigator access, and a patient must enable sharing in
 myBETAapp for HCPs to obtain this information.

 Does BETASERON® require refrigeration?
 No. BETASERON can be stored at room temperature.

                                                                                                         IMPORTANT SAFETY INFORMATION (continued)
 INDICATIONS                                                                                             Most Common Side Effects:
 BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms
                                                                                                         The most common side effects of BETASERON include low white blood cell count, increases in your
 of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease,
                                                                                                         liver enzymes, headache, increase in your muscle tension, pain, rash, problems sleeping, stomach
 and active secondary progressive disease, in adults.
                                                                                                         pain, weakness. These are not all the possible side effects of BETASERON.
                                                                                                         Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
                                                                                                         Tell your healthcare provider about all the medicines you take and your medical conditions.
                             Please see Important Safety Information throughout and Important            You are encouraged to report side effects or quality complaints of prescription drugs to the FDA by
                             Facts About BETASERON® on pages 14 and 15.                                  visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

 12                                                                                                                                                                                                       13
Important Facts About                                                                                 Symptoms of injection site problems may include:
                                                                                                         – swelling, redness, or pain at the injection site
BETASERON® (interferon beta-1b)                                                                          – fluid drainage from the injection site
                                                                                                         – breaks in your skin or blue-black skin discoloration
                                                                                                      It is important for you to change your injection site each time you inject BETASERON. This will
What is BETASERON?                                                                                    lessen the chance of you having a serious skin reaction at the site where you inject BETASERON.
BETASERON is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to     Avoid injecting BETASERON into an area of skin that is sore, reddened, infected or has
include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive   other problems.
disease, in adults.                                                                                   • flu-like symptoms. BETASERON can cause flu-like symptoms including:
                                                                                                         – fever, chills, tiredness, sweating, muscle aches when you first start to use it.
Who should not take BETASERON?                                                                        These symptoms may decrease over time. Taking medicines for fever and pain relief on the days
Do not take BETASERON if you are allergic to interferon beta-1b, to another interferon beta,          you are using BETASERON may help decrease these symptoms.
to human albumin, or mannitol.
                                                                                                      • seizures. Some people have had seizures while taking BETASERON, including people who have
                                                                                                         never had seizures before. It is not known if the seizures were related to their MS, to BETASERON,
What Warnings and Precautions should I know about BETASERON?                                             or to a combination of both. If you have a seizure after taking BETASERON call your healthcare
BETASERON can cause serious side effects, including:                                                      provider right away.
• liver problems including liver failure.
Symptoms of liver problems may include:                                                               What should I know before starting BETASERON?
• yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting,       Before you take BETASERON, tell your healthcare provider if you:
  bruising easily or bleeding problems.                                                               • have or have had depression (sinking feeling or sadness), anxiety (feeling uneasy, nervous, or
Your healthcare provider will do blood tests to check for these problems while you                      fearful for no reason) or trouble sleeping
take BETASERON.                                                                                       • have or have had liver problems
• serious allergic reactions. Serious allergic reactions can happen quickly and may happen after      • have or have had blood problems such as bleeding or bruising easily, low red blood cells (anemia)
  your first dose of BETASERON or after you have taken BETASERON many times. Symptoms                    or low white blood cells
  may include:                                                                                        • have or have had seizures
   – difficulty breathing or swallowing                                                                 • have or have had heart problems
   – swelling of the mouth or tongue                                                                  • are pregnant or plan to become pregnant
   – rash, itching, or skin bumps
                                                                                                      • are breastfeeding or plan to breastfeed. It is not known if BETASERON passes into your
• depression or suicidal thoughts. Call your healthcare provider right away if you have any of          breast milk.
   the following symptoms, especially if they are new, worse, or worry you:
                                                                                                      Tell your healthcare provider about all the medicines you take, including prescription and
   – thoughts about suicide or dying                                                                  nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep
   – new or worse depression                                                                          a list of them to show your healthcare provider and pharmacist when you get a new medicine.
   – new or worse anxiety
   – trouble sleeping (insomnia)                                                                      What are the possible side effects of BETASERON?
   – acting aggressive, being angry, or violent                                                       The most common side effects of BETASERON include:
   – acting on dangerous impulses                                                                     • low white blood cell count, increases in your liver enzymes, headache, increases in your muscle
   – hallucinations                                                                                     tension, pain, rash, problems sleeping, stomach pain, and weakness.
   – other unusual changes in behavior or mood
                                                                                                      These are not all the possible side effects of BETASERON. For more information, ask your
• heart problems. BETASERON may worsen heart problems including congestive heart failure.
                                                                                                      healthcare provider or pharmacist.
   Symptoms of heart problems may include:
   – swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness    Tell your healthcare provider if you have any side effect that bothers you or does not go away.
      in chest, increased need to urinate at night, not being able to lay flat in bed.                 For important risk and use information about BETASERON, please see the enclosed Full
• injection site problems. Serious skin reactions can happen in some people including areas of        Prescribing Information.
   severe damage to skin and the tissue below the skin (necrosis). These reactions can happen
                                                                                                      The risk information provided here is not comprehensive. To learn more about BETASERON, talk
   anywhere you inject BETASERON.
                                                                                                      with your healthcare provider or pharmacist. Visit www.betaseron.com to obtain the
                                                                                                      FDA-approved product labeling or call 1-888-842-2937.
                                                                                                      You are encouraged to report side effects or quality complaints of prescription drugs to the FDA.
                                                                                                      Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
                          Please see Important Safety Information throughout.

14                                                                                                                                                                                                       15
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                                                                                                                                           Innovative
ge                                                                                                   24/7 BETA Nurse                       financial
                                                                                                     support                               support

                                                                                                     BETACONNECT™,                  ®
                                                                                                                                           myBETAapp™,
                                                                                                     a fully electronic                    for on-the-go
                                                                                                     autoinjector                          tracking

                                                                              Models used for illustrative purposes only.

                          To learn more about CIS or RRMS and treatment with BETASERON,
                    visit betaseron.com/efficacy and talk with your healthcare provider today.

                                                                                                                                                  Last edits made:
                                                                                                                                                     May 11, 2017

       Please see Important Safety Information throughout and Important Facts About
       BETASERON® on pages 14 and 15. For BETACONNECT™ Instructions for Use, please visit
       www.betaconnectifu.com, and for myBETAapp™ Instructions for Use, please visit
       www.mybetaappifu.com.                                   Last edits made:
                                                                                                               May 11, 2017

       BAYER, the Bayer Cross, BETAPLUS and BETASERON are registered trademarks of Bayer.
       BETACONNECT and myBETAapp are trademarks of Bayer. The Bluetooth® word mark and
       logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such
       marks by Bayer is under license. iPhone is a registered trademark of Apple Inc., registered
       in the U.S. and other countries.

                                  ©2019 Bayer. Whippany, NJ 07981.
                                  All rights reserved. PP-BETA-S-US-0564-1                            September 2019
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