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:
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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.
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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.