b"IMPORTANT SAFETY INFORMATION (cont'd)ZEPOSIA may cause serious side effects, including (cont'd): ZEPOSIA can cause serious side effects, including: Slow heart rate (also known as bradyarrhythmia) when you liver problems. Your healthcare provider will do blood tests to checkstart taking ZEPOSIA. ZEPOSIA may cause your heart rate toyour liver before you start taking ZEPOSIA. Call your healthcare temporarily slow down, especially during therst 8 days. Youprovider right away if you have any of the following symptoms:will have a test to check the electrical activity of your heart unexplained nausealoss of appetitecalled an electrocardiogram (ECG) before you take yourrst vomiting yellowing of the whites of dose of ZEPOSIA. s tomach area your eyes or skinCall your healthcare provider if you experience the following (abdominal) paindark-colored urinesymptoms of slow heart rate:tirednessdizzinessshortness of breathincreased blood pressure. Your healthcare provider should check your lightheadednessconfusionfeeling like your heart c hest pain blood pressure during treatment with ZEPOSIA. A sudden, severeis beating slowly or t iredness increase in blood pressure (hypertensive crisis) can happen when youskipping beatseat certain foods that contain high levels of tyramine Follow directions from your healthcare provider when starting breathing problems. Some people who take ZEPOSIA have shortnessZEPOSIA and when you miss a dose. of breath. Call your healthcare provider right away if you have new or Continue reading for additional possible serious side effectsworsening breathing problemsof ZEPOSIA.a problem with your vision called macular edema. Your risk of Before taking ZEPOSIA, tell your healthcare provider about all ofmacular edema is higher if you have diabetes or have had an your medical conditions, including if you: in ammation of your eye called uveitis. Your healthcare providerhave a fever or infection, or are unable toght infections due toshould test your vision before you start taking ZEPOSIA if you are a disease, or take or have taken medicines that lower yourat higher risk for macular edema or any time you notice vision immune system changes during treatment with ZEPOSIA. Call your healthcarebefore you start ZEPOSIA, your healthcare provider may giveprovider right away if you have any of the following symptoms:you a chickenpox (varicella zoster virus) vaccine if you have not had one before blurriness or shadows in ablind spot in the centerhave had chickenpox or have received the vaccine forthe center of your vision of your vision chickenpox. Your healthcare provider may do a blood test for s ensitivity to lightunusually colored visionthe chickenpox virus. You may need to get the full course of the swelling and narrowing of the blood vessels in your brain. Posterior vaccine and wait 1 month before taking ZEPOSIA Reversible Encephalopathy Syndrome (PRES) is a rare conditionhave a slow heart rate that has happened with ZEPOSIA and with drugs in the samehave an irregular or abnormal heartbeat (arrhythmia) have a history of stroke class. Symptoms of PRES usually get better when you stop takinghave or have had heart problems, including a heart attack orZEPOSIA. If left untreated, it may lead to stroke. Your healthcare chest pain provider will do a test if you have any symptoms of PRES. Callhave high blood pressure your healthcare provider right away if you have any of thehave liver problems following symptoms: have breathing problems, including during your sleeps udden severe headache sudden loss of vision or otherhave eye problems, especially an in ammation of the eyes udden confusion changes in your visioncalled uveitishave diabetes s eizure are or plan to become pregnant or if you become pregnant severe worsening of MS after stopping ZEPOSIA. When ZEPOSIA within 3 months after you stop taking ZEPOSIA. ZEPOSIA mayis stopped, symptoms of MS may return and become worse harm your unborn baby. If you are a female who can becomecompared to before or during treatment. Always talk to your pregnant, talk to your healthcare provider about what birthhealthcare provider before you stop taking ZEPOSIA for any reason. control method is right for you during your treatment withTell your healthcare provider if you have worsening symptoms of ZEPOSIA and for 3 months after you stop taking ZEPOSIA MS after stopping ZEPOSIA. are breastfeeding or plan to breastfeed. It is not known ifZEPOSIA passes into your breast milk. Talk to your allergic reactions. Call your healthcare provider if you have healthcare provider about the best way to feed yoursymptoms of an allergic reaction, including a rash, itchy hives, or baby if you take ZEPOSIA swelling of the lips, tongue, or faceTell your healthcare provider about all the medicines you take orThe most common side effects of ZEPOSIA can include:have recently taken, including prescription and over-the-counter upper respiratory tract infectionsmedicines, vitamins, and herbal supplements. Using ZEPOSIA with elevated liver enzymesother medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken:low blood pressure when you stand up (orthostatic hypotension)medicines that affect your immune system, such as alemtuzumabpainful and frequent urination (signs of urinary tract infection) medicines to control your heart rhythm (antiarrhythmics) back painor heartbeathigh blood pressure strong CYP2C8 inhibitors such as gem brozil or clopidogrel These are not all of the possible side effects of ZEPOSIA. For moremedicines that inhibit breast cancer resistance protein transporters, such as cyclosporine and eltrombopag information, ask your healthcare provider or pharmacist. CYP2C8 inducers such as rifampin Call your healthcare provider for medical advice about sideopioids (pain medicine), medicines to treat depression, andeffects. You are encouraged to report negative side effects ofmedicines to treat Parkinson's disease prescription drugs to the FDA. Visit www.fda.gov/medwatch,You should not receive live vaccines during treatment with ZEPOSIA,or call 1-800-FDA-1088. for at least 1 month before taking ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Vaccines may not work as well when givenduring treatment with ZEPOSIA. Please see the Important Facts on the 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. 12/20 US-ZEP-20-1199 1"