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IMPORTANT SAFETY INFORMATION

INDICATIONS

Multiple Sclerosis (MS): 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.
Ulcerative Colitis (UC): ZEPOSIA is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults.

It is not known if ZEPOSIA is safe and effective in children.

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 (such as selegiline, phenelzine, linezolid)

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 (these may be 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.

  • Progressive multifocal leukoencephalopathy (PML). ZEPOSIA can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Symptoms of PML get worse over days to weeks. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including:
    • weakness on one (1) side of your body
    • loss of coordination in your arms or legs
    • decreased strength
    • problems with balance
    • changes in your vision
    • changes in your thinking or memory
    • confusion
    • changes in your personality
  • 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 that you take ZEPOSIA. 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
  • received a vaccine in the past 30 days or are scheduled to receive a vaccine. ZEPOSIA may cause vaccines to be less effective
  • 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. Talk to your healthcare provider about what birth control method is right for you during this time. If you become pregnant while taking ZEPOSIA for MS, tell your healthcare provider right away and enroll in the ZEPOSIA Pregnancy Registry by calling 1-877-301-9314 or visiting www.zeposiapregnancyregistry.com
  • 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
  • CYP2C8 inducers such as rifampin
  • CYP2C8 inhibitors such as gemfibrozil (medicine to treat high fat in your blood)
  • opioids (pain medicine), medicines to treat depression, and medicines to treat Parkinson’s disease
  • medicines to control your heart rate and blood pressure (beta blocker medicines and calcium channel blocker medicines)
  • medicines called monoamine oxidase (MAO) inhibitors (such as selegiline, phenelzine, linezolid)

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. ZEPOSIA may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start taking ZEPOSIA and periodically during treatment. 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.
  • 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. Macular edema can cause some of the same vision symptoms as a multiple sclerosis (MS) attack (optic neuritis). You may not notice any symptoms with macular edema. Your healthcare provider should test your vision around the time you start taking ZEPOSIA, periodically while you continue taking ZEPOSIA, and at any time you notice vision changes during treatment with ZEPOSIA. Your risk for macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis. 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
  • types of skin cancer, including basal cell carcinoma, melanoma, and squamous cell carcinoma. Tell your healthcare provider if you have any changes in the appearance of your skin, including changes in a mole, a new darkened area on your skin, a sore that does not heal, or growths on your skin, such as a bump that may be shiny, pearly white, skin-colored, or pink. Your doctor should check your skin for any changes at the start of and during treatment with ZEPOSIA. Limit the amount of time you spend in sunlight and ultraviolet (UV) light. Wear protective clothing and use a sunscreen with a high sun protection factor.
  • 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 multiple sclerosis (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.

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
  • headache

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.

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