b"IMPORTANT SAFETY INFORMATION (cont'd)ZEPOSIA may cause serious side effects, including (cont'd): You should not receive live vaccines during treatment with o ZEPOSIA, for at least 1 month before taking ZEPOSIA and for headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (symptoms of meningitis, an3 months after you stop taking ZEPOSIA. Vaccines may not infection of the lining around your brain and spine) work as well when given during treatment with ZEPOSIA.Your healthcare provider may delay starting or may stop yourZEPOSIA can cause serious side effects, including:ZEPOSIA treatment if you have an infection.liver problems. Your healthcare provider will do bloodSlow heart rate (also known as bradyarrhythmia) whentests to check your liver before you start taking ZEPOSIA. you start taking ZEPOSIA. ZEPOSIA may cause your heartCall your healthcare provider right away if you have any of rate to temporarily slow down, especially during therstthe following symptoms:8 days. You will have a test to check the electrical activity ofo unexplained nausea o loss of appetiteyour heart called an electrocardiogram (ECG) before you takeo vomiting o yellowing of the whitesyourrst dose of ZEPOSIA. o shortness of breatho stomach areao of your eyes or skin Call your healthcare provider if you experience the following(abdominal) pain dark-colored urinesymptoms of slow heart rate: o tirednesso dizziness increased blood pressure. Your healthcare provider should o lightheadedness o confusion check your blood pressure during treatment with ZEPOSIA. oeeling like your hearto chest pain A sudden, severe increase in blood pressure (hypertensive fis beating slowly oro tiredness crisis) can happen when you eat certain foods that contain skipping beats high levels of tyramineFollow directions from your healthcare provider when breathing problems. Some people who take ZEPOSIA have starting ZEPOSIA and when you miss a dose. shortness of breath. Call your healthcare provider right away Continue reading for additional possible serious side effectsif you have new or worsening breathing problemsof ZEPOSIA.a problem with your vision called macular edema. Your Before taking ZEPOSIA, tell your healthcare provider aboutrisk of macular edema is higher if you have diabetes or all of your medical conditions, including if you: have had an in ammation of your eye called uveitis. Yourhave a fever or infection, or are unable toght infections duehealthcare provider should test your vision before you start to a disease, or take or have taken medicines that lower yourtaking ZEPOSIA if you are at higher risk for macular edema immune system or any time you notice vision changes during treatment withbefore you start ZEPOSIA, your healthcare provider may giveZEPOSIA. Call your healthcare provider right away if you you a chickenpox (varicella zoster virus) vaccine if you havehave any of the following symptoms:not had one before o blurriness or shadows ino a blind spot in the have had chickenpox or have received the vaccine forthe center of your vision center of your visionchickenpox. Your healthcare provider may do a blood test foro sensitivity to light o unusually colored visionthe chickenpox virus. You may need to get the full course of swelling and narrowing of the blood vessels in your the vaccine and wait 1 month before taking ZEPOSIA brain. Posterior Reversible Encephalopathy Syndromehave a slow heart rate (PRES) is a rare condition that has happened with ZEPOSIAhave an irregular or abnormal heartbeat (arrhythmia) and with drugs in the same class. Symptoms of PREShave a history of stroke usually get better when you stop taking ZEPOSIA. If lefthave or have had heart problems, including a heart attack oruntreated, it may lead to stroke. Your healthcare provider chest pain will do a test if you have any symptoms of PRES. Call yourhave high blood pressure healthcare provider right away if you have any of thehave liver problems following symptoms: have breathing problems, including during your sleep o sudden severeo sudden loss of vision have eye problems, especially an in ammation of the eyeheadache or other changes in called uveitis o sudden confusion your vision have diabeteso seizure are or plan to become pregnant or if you become pregnant severe worsening of MS after stopping ZEPOSIA. When within 3 months after you stop taking ZEPOSIA. ZEPOSIA mayZEPOSIA is stopped, symptoms of MS may return and harm your unborn baby. If you are a female who can becomebecome worse compared to before or during treatment. pregnant, talk to your healthcare provider about what birthAlways talk to your healthcare provider before you stop taking control method is right for you during your treatment withZEPOSIA for any reason. Tell your healthcare provider if you ZEPOSIA and for 3 months after you stop taking ZEPOSIA have worsening symptoms of MS after stopping ZEPOSIA. are breastfeeding or plan to breastfeed. It is not known allergic reactions. Call your healthcare provider if you have if ZEPOSIA passes into your breast milk. Talk to your healthcare provider about the best way to feed yoursymptoms of an allergic reaction, including a rash, itchy hives, baby if you take ZEPOSIA or swelling of the lips, tongue, or faceTell your healthcare provider about all the medicines youThe most common side effects of ZEPOSIA can include:take or have recently taken, including prescription and upper respiratory tract infectionsover-the-counter medicines, vitamins, and herbal supplements. elevated liver enzymes Using ZEPOSIA with other medicines can cause serious side low blood pressure when you stand up (orthostatic effects. Especially tell your healthcare provider if you take orhypotension)have taken:painful and frequent urination (signs of urinary tract infection) medicines that affect your immune system, such back painas alemtuzumabhigh blood pressure medicines to control your heart rhythm (antiarrhythmics)These are not all of the possible side effects of ZEPOSIA. For or heartbeat more information, ask your healthcare provider or pharmacist.strong CYP2C8 inhibitors such as gem brozil or clopidogrel Call your healthcare provider for medical advice about sidemedicines that inhibit breast cancer resistance proteineffects. You are encouraged to report negative side effects of transporters, such as cyclosporine and eltrombopag prescription drugs to the FDA. Visit www.FDA.gov/medwatchCYP2C8 inducers such as rifampin or call 1-800-FDA-1088.opioids (pain medicine), medicines to treat depression, and medicines to treat Parkinson's disease Please see Brief Summary of Information on next 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. Printed in the USA. 06/20 US-ZEP-20-0155 1"