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Once daily Zeposia (ozanimod) | 0.92 mg capsules

ZEPOSIA: the latest in relapsing MS treatment
is a once-daily pill

If you have multiple sclerosis (MS), finding a treatment that works best
for you means knowing what treatment options are available. So you
should know about a new treatment for relapsing MS patients: ZEPOSIA,
a once-daily pill.
ZEPOSIA® (ozanimod) 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. It is not known if ZEPOSIA is safe and effective in children.

In two separate clinical studies, ZEPOSIA was more
effective at reducing relapses and new or enlarging
lesions (T2) than a leading injectable
medicine (Avonex).*

The progression of physical disability was measured, too.

*Avonex (interferon beta-1a).

Fewer relapses

  • In a one-year study: 48% fewer relapses than those who took a leading injectable
  • In a two-year study: 38% fewer relapses than those who took a leading injectable

One-year study: People taking ZEPOSIA had an Annualized Relapse Rate (ARR) of 0.181 vs 0.350 with a leading injectable. Two-year study: 0.172 ARR with ZEPOSIA vs 0.276 with a leading injectable.

More people were relapse free

  • In a one-year study: 78% of people were relapse free with ZEPOSIA vs 66% with
    a leading injectable
  • In a two-year study: 76% of people were relapse free with ZEPOSIA vs 64% with
    a leading injectable

A relapse is defined as new or worsening symptoms (directly associated with MS) that last more than 24 hours and are preceded by a mostly stable neurological state by at least
30 days.

Fewer new or enlarging lesions (T2)

  • In a one-year study: 48% fewer new or enlarging lesions (T2) than those who
    took a leading injectable§
  • In a two-year study: 42% fewer new or enlarging lesions (T2) than those who
    took a leading injectable§

§

One-year study: People taking ZEPOSIA had an average of 1.47 new or enlarging lesions (T2) vs 2.84 with a leading injectable. Two-year study: An average of 1.84 new or enlarging lesions (T2) vs 3.18 with a leading injectable.

Disability progression was also measured

When taking ZEPOSIA or Avonex, 9 out of 10 people experienced no progression of physical disability.

  • THERE WAS NO SIGNIFICANT DIFFERENCE in disability progression
    between people who took ZEPOSIA (7.6% of people) and those who took
    a leading injectable medicine (7.8%)
  • Physical disability progression was measured every 3 months and combined
    from both studies

A total of 895 people were in the one-year study—447 people took ZEPOSIA and 448 people took a
leading injectable. A total of 874 people were in the two-year study—433 people took ZEPOSIA and
441 took a leading injectable.

Selected Important Safety Information

ZEPOSIA can cause serious side effects including: infections that can be life-threatening and
cause death, slow heart rate, liver problems, increased blood pressure, breathing problems, macular edema, posterior reversible encephalopathy syndrome (PRES), severe worsening of MS after stopping ZEPOSIA compared to before or during treatment, and allergic reactions. The most common side effects of ZEPOSIA can include: upper respiratory tract infections, elevated liver enzymes, low blood pressure when you stand up, painful and frequent urination, back pain, and high blood pressure. These are not all of the possible side effects of ZEPOSIA.
For more information, please read the Important Safety Information.

See More Study Results for Zeposia

INDICATION

ZEPOSIA® (ozanimod) 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.
It is not known if ZEPOSIA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take ZEPOSIA if you:

  • have had a heart attack, chest pain (unstable angina), stroke or mini-stroke (transient
    ischemic attack or TIA), or certain types of heart failure in the last 6 months
  • have or have had a history of certain types of an irregular or abnormal heartbeat
    (arrhythmia) that is not corrected by a pacemaker
  • have untreated, severe breathing problems during your sleep (sleep apnea)
  • take certain medicines called monoamine oxidase (MAO) inhibitors

Talk to your healthcare provider before taking ZEPOSIA if you have any of these conditions
or do not know if you have any of these conditions.

ZEPOSIA may cause serious side effects, including:

  • Infections. ZEPOSIA can increase your risk of serious infections that can be
    life-threatening and cause death. ZEPOSIA lowers the number of white blood cells
    (lymphocytes) in your blood. This will usually go back to normal within 3 months of
    stopping treatment. Your healthcare provider may do a blood test of your white blood cells
    before you start taking ZEPOSIA.
  • Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with ZEPOSIA and for 3 months after your last dose of ZEPOSIA.

    • fever
    • feeling very tired
    • flu-like symptoms
    • cough
    • painful and frequent urination (signs of a urinary tract infection)
    • rash
    • headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (symptoms
      of meningitis, an infection of the lining around your brain and spine)

Your healthcare provider may delay starting or may stop your ZEPOSIA treatment if you
have an infection.

  • Slow heart rate (also known as bradyarrhythmia) when you start taking ZEPOSIA. ZEPOSIA may cause your heart rate to temporarily slow down, especially during the first 8 days. You will have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose of ZEPOSIA.
  • Call your healthcare provider if you experience the following symptoms of slow heart rate:

    • dizziness
    • lightheadedness
    • feeling like your heart is beating slowly or skipping beats
    • shortness of breath
    • confusion
    • chest pain
    • tiredness

Follow directions from your healthcare provider when starting ZEPOSIA and when you
miss a dose.

Continue reading for additional possible serious side effects of ZEPOSIA.

Before taking ZEPOSIA, tell your healthcare provider about all of your medical
conditions, including if you:

  • have a fever or infection, or are unable to fight infections due to a disease, or take or have
    taken medicines that lower your immune system
  • before you start ZEPOSIA, your healthcare provider may give you a chickenpox (varicella
    zoster virus) vaccine if you have not had one before
  • have had chickenpox or have received the vaccine for chickenpox. Your healthcare provider may do a blood test for the chickenpox virus. You may need to get the full course of the vaccine and wait 1 month before taking ZEPOSIA
  • have a slow heart rate
  • have an irregular or abnormal heartbeat (arrhythmia)
  • have a history of stroke
  • have or have had heart problems, including a heart attack or chest pain
  • have high blood pressure
  • have liver problems
  • have breathing problems, including during your sleep
  • have eye problems, especially an inflammation of the eye called uveitis
  • have diabetes
  • are or plan to become pregnant or if you become pregnant within 3 months after you stop
    taking ZEPOSIA. ZEPOSIA may harm your unborn baby. If you are a female who can
    become pregnant, talk to your healthcare provider about what birth control method is right for
    you during your treatment with ZEPOSIA and for 3 months after you stop taking ZEPOSIA
  • are breastfeeding or plan to breastfeed. It is not known if ZEPOSIA passes into your
    breast milk. Talk to your healthcare provider about the best way to feed your baby if you
    take ZEPOSIA

Tell your healthcare provider about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using ZEPOSIA with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken:

  • medicines that affect your immune system, such as alemtuzumab
  • medicines to control your heart rhythm (antiarrhythmics) or heartbeat
  • strong CYP2C8 inhibitors such as gemfibrozil or clopidogrel
  • medicines that inhibit breast cancer resistance protein transporters, such as cyclosporine and eltrombopag
  • CYP2C8 inducers such as rifampin
  • opioids (pain medicine), medicines to treat depression, and medicines to treat
    Parkinson’s disease

You should not receive live vaccines during treatment with ZEPOSIA, for at least 1 month before taking ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Vaccines may not work as well when given during treatment with ZEPOSIA.

ZEPOSIA can cause serious side effects, including:

  • liver problems. Your healthcare provider will do blood tests to check your liver before you
    start taking ZEPOSIA. Call your healthcare provider right away if you have any of the
    following symptoms:
    • unexplained nausea
    • vomiting
    • stomach area (abdominal) pain
    • tiredness
    • loss of appetite
    • yellowing of the whites of your eyes or skin
    • dark-colored urine
  • increased blood pressure. Your healthcare provider should check your blood pressure during treatment with ZEPOSIA. A sudden, severe increase in blood pressure (hypertensive crisis) can happen when you eat certain foods that contain high levels of tyramine
  • breathing problems. Some people who take ZEPOSIA have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems
  • a problem with your vision called macular edema. Your risk of macular edema is
    higher if you have diabetes or have had an inflammation of your eye called uveitis.
    Your healthcare provider should test your vision before you start taking ZEPOSIA if
    you are at higher risk for macular edema or any time you notice vision changes during
    treatment with ZEPOSIA. Call your healthcare provider right away if you have any of
    the following symptoms:
    • blurriness or shadows in the center of your vision
    • sensitivity to light
    • a blind spot in the center of your vision
    • unusually colored vision
  • swelling and narrowing of the blood vessels in your brain. Posterior Reversible Encephalopathy Syndrome (PRES) is a rare condition that has happened with ZEPOSIA
    and with drugs in the same class. Symptoms of PRES usually get better when you stop
    taking ZEPOSIA. If left untreated, it may lead to stroke. Your healthcare provider will do a
    test if you have any symptoms of PRES. Call your healthcare provider right away if you
    have any of the following symptoms:
    • sudden severe headache
    • sudden confusion
    • sudden loss of vision or other changes in your vision
    • seizure
  • severe worsening of MS after stopping ZEPOSIA. When ZEPOSIA is stopped, symptoms of MS may return and become worse compared to before or during treatment. Always talk to your healthcare provider before you stop taking ZEPOSIA for any reason. Tell your healthcare provider if you have worsening symptoms of MS after stopping ZEPOSIA.
  • allergic reactions. Call your healthcare provider if you have symptoms of an allergic reaction, including a rash, itchy hives, or swelling of the lips, tongue, or face

The most common side effects of ZEPOSIA can include:

  • upper respiratory tract infections
  • elevated liver enzymes
  • low blood pressure when you stand up (orthostatic hypotension)
  • painful and frequent urination (signs of urinary tract infection)
  • back pain
  • high blood pressure

These are not all of the possible side effects of ZEPOSIA. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.

Bristol Myers Squibb is committed to transparency. For information on the list price of
ZEPOSIA as well as information regarding average out-of-pocket costs and assistance
programs, please visit our pricing information page.

ZEPOSIA® is a registered trademark of Celgene Corporation, a Bristol-Myers Squibb
Company. Avonex® is a registered trademark of Biogen.

© 2020 Bristol-Myers Squibb Company. All rights reserved. 08/20 US-ZEP-20-0281

Bristol Myers Squibb logo

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