b'IMPORTANT The information below does not take the place of talking with your healthcare professional. Only your FACTS healthcare professional knows the specics of your condition and how ZEPOSIA (ozanimod) may t into your overall therapy. Talk to your healthcare professional if you have any questions about ZEPOSIA (pronounced zeh-poe-see-ah).WhatisthemostimportantinformationIshouldknowabouthave a slow heart rate. liver problems.ZEPOSIA (ozanimod) may cause liver problems. ZEPOSIA (ozanimod)? have an irregular or abnormal heartbeat (arrhythmia). Your healthcare provider will do blood tests to check your liver before ZEPOSIA may cause serious side effects, including: have a history of a stroke. you start taking ZEPOSIA. Call your healthcare provider right away if 1.Infections. ZEPOSIA can increase your risk of serious infections thathave heart problems, including a heart attack or chest pain. you have any of the following symptoms:can be life-threatening and cause death. ZEPOSIA lowers the numberhave high blood pressure.unexplained nausealoss of appetiteof white blood cells (lymphocytes) in your blood. This will usuallyhave liver problems.vomitingyellowing of the whites of your go back to normal within 3 months of stopping treatment. Yourhave breathing problems, including during your sleep.stomach area (abdominal)eyes or skinhealthcare provider may do a blood test of your white blood cellspaindark colored urinebefore you start taking ZEPOSIA. have eye problems, especially an inammation of the eye called uveitis.tirednessCall your healthcare provider right away if you have any of thehave diabetes.following symptoms of an infection during treatment with ZEPOSIAare pregnant or plan to become pregnant. ZEPOSIA (ozanimod)increased blood pressure.Your healthcare provider should check and for 3 months after your last dose of ZEPOSIA: may harm your unborn baby. Talk with your healthcare provider if youyour blood pressure during treatment with ZEPOSIA. A sudden,feverrash are pregnant or plan to become pregnant. If you are a female who cansevere increase in blood pressure (hypertensive crisis) can happenfeeling very tiredheadache with fever, neckbecome pregnant, you should use effective birth control during yourwhen you eat certain foods that contain high levels of tyramine. u-like symptoms stiffness, sensitivity totreatment with ZEPOSIA and for 3 months after you stop takingSee How should I take ZEPOSIA? section for more information.light, nausea or confusionZEPOSIA. Talk with your healthcare provider about what birth controlbreathing problems.Some people who take ZEPOSIA have shortnesscough (these may be symptoms ofmethod is right for you during this time. Tell your healthcare providerof breath. Call your healthcare provider right away if you have newpainful and frequent urinationmeningitis, an infection of theright away if you become pregnant while taking ZEPOSIA or if youor worsening breathing problems.(signs of a urinary tractlining around your brain andbecome pregnant within 3 months after you stop taking ZEPOSIA. a problem with your vision called macular edema.Your risk infection) spine) are breastfeeding or plan to breastfeed. It is not known if ZEPOSIAfor macular edema is higher if you have diabetes or have had an Your healthcare provider may delay starting or may stop your ZEPOSIApasses into your breast milk. Talk to your healthcare provider aboutinammation of your eye called uveitis. Your healthcare provider treatment if you have an infection. the best way to feed your baby if you take ZEPOSIA. should test your vision before you start taking ZEPOSIA if you are at 2.Slow heart rate (also known as bradyarrhythmia) when you startTell your healthcare provider about all the medicines you take or havehigher risk for macular edema or at any time you notice vision changes taking ZEPOSIA.ZEPOSIA may cause your heart rate to temporarilyrecently taken, including prescription and over-the-counter medicines,during treatment with ZEPOSIA. Call your healthcare provider right slow down, especially during the rst 8 days that you take ZEPOSIA.vitamins, and herbal supplements. Using ZEPOSIA with other medicinesaway if you have any of the following symptoms:You will have a test to check the electrical activity of your heartcan cause serious side effects. Especially tell your healthcare provider if blurriness or shadows in the a blind spot in the center of called an electrocardiogram (ECG) before you take your rst dose ofyou take or have taken: center of your vision your visionZEPOSIA. Call your healthcare provider if you experience the followingmedicines that affect your immune system, such as alemtuzumabsensitivity to lightunusually colored visionsymptoms of slow heart rate: medicines to control your heart rhythm (antiarrhythmics), or heart beat swelling and narrowing of blood vessels in your brain.Aconditiondizzinessshortness of breath called PRES (Posterior Reversible Encephalopathy Syndrome) is a lightheadednessconfusion strong CYP2C8 inhibitors such as gembrozil or clopidogrel rare condition that has happened with ZEPOSIA and with drugsfeeling like your heart is chest pain medicines that inhibit breast cancer resistance protein transporters,in the same class. Symptoms of PRES usually get better when you beating slowly or skipping tiredness such as cyclosporine and eltrombopag stop taking ZEPOSIA. If left untreated, it may lead to a stroke. Your beats CYP2C8 inducers such as rifampin healthcare provider will do a test if you have any symptoms of Follow directions from your healthcare provider when starting ZEPOSIAopioids (pain medicine) PRES. Call your healthcare provider right away if you have any of the and when you miss a dose. See How should I take ZEPOSIA?. medicines to treat depression following symptoms:SeeWhat are the possible side effects of ZEPOSIA? for moremedicines to treat Parkinsons diseasesudden severe headachesudden loss of vision or other information about side effects. You should not receivelivevaccines during treatment with ZEPOSIA, sudden confusion changes in your visionfor at least 1 month before taking ZEPOSIA and for 3 months after you seizurestop taking ZEPOSIA. Vaccines may not work as well when given duringsevere worsening of multiple sclerosis (MS) after stopping What is ZEPOSIA? treatment with ZEPOSIA. ZEPOSIA.When ZEPOSIA is stopped, symptoms of MS may return ZEPOSIA is a prescription medicine used to treat relapsing formsTalk with your healthcare provider if you are not sure if you take any ofand become worse compared to before or during treatment. Always of multiple sclerosis (MS), to include clinically isolated syndrome,these medicines. Know the medicines you take. Keep a list of them to showtalk to your healthcare provider before you stop taking ZEPOSIA for any relapsing-remitting disease, and active secondary progressive disease,your healthcare provider and pharmacist when you get a newmedicine. reason. Tell your healthcare provider if you have worsening symptoms in adults. of MS after stopping ZEPOSIA.It is not known if ZEPOSIA is safe and effective in children. allergic reactions.Call your healthcare provider if you have symptoms How should I take ZEPOSIA? of an allergic reaction, including a rash, itchy hives, or swelling of the Do not take ZEPOSIA if you: You will receive a 7-day starter pack. You must start ZEPOSIA by slowlylips, tongue or face.have had a heart attack, chest pain (unstable angina), stroke orincreasing doses over the rst week. Follow the dose schedule of:The most common side effects of ZEPOSIA can include:mini-stroke (transient ischemic attack or TIA), or certain types ofDays 1-4: 0.23 mg 1 time a day; Days 5-7: 0.46 mg 1time a day; upper respiratory tract infectionsheart failure in the last 6 months. Days 8 and thereafter: 0.92 mg 1 time a day. This may reduce the risk ofelevated liver enzymeshave or have had a history of certain types of an irregular or abnormalslowing of the heart rate.low blood pressure when you stand up (orthostatic hypotension)heartbeat (arrhythmia) that is not corrected by a pacemaker. Take ZEPOSIA exactly as your healthcare provider tells you to take it. painful and frequent urination (signs of urinary tractinfection)haveuntreated,severebreathingproblemsduring yoursleepTake ZEPOSIA 1 time each day. back pain(sleep apnea). Swallow ZEPOSIA capsules whole. high blood pressuretake certain medicines called monoamine oxidase (MAO) inhibitorsTake ZEPOSIA with or without food. These are not all of the possible side effects of ZEPOSIA. For more (e.g., selegiline, phenelzine, linezolid). Avoid certain foods that are high (over 150 mg) in tyramine such asinformation, ask your healthcare provider or pharmacist. Call your Talk to your healthcare provider before taking ZEPOSIA if you have anyaged, fermented, cured, smoked and pickled foods. Eating these foodshealthcare provider for medical advice about side effects. You may report of these conditions or do not know if you have any of these conditions. while taking ZEPOSIA may increase your blood pressure. side effects to FDA at1-800-FDA-1088.Do not stop taking ZEPOSIA without talking with your healthcare Before taking ZEPOSIA, tell your healthcare provider about all of yourprovider rst. General information about the safe and effective use of ZEPOSIA. medical conditions, including if you: Do not skip a dose. Medicines are sometimes prescribed for purposes other than those listed have a fever or infection, or you are unable to ght infections dueStart taking ZEPOSIA with a 7-day starter pack. in a Medication Guide. Do not take ZEPOSIA for conditions for which it to a disease or take or have taken medicines that lower yourIf you miss 1 or more days of your ZEPOSIA dose during the rstwas not prescribed. Do not give ZEPOSIA to other people, even if they immune system. 14days of treatment, talk to your healthcare provider. You will needhave the same symptoms you have. It may harm them. You can ask your received a vaccine in the past 30 days or are scheduled to receiveto begin with another ZEPOSIA 7-day starter pack. healthcare provider or pharmacist for information about ZEPOSIA that is avaccine. ZEPOSIA may cause vaccines to be less effective. If you miss a dose of ZEPOSIA after the rst 14 days of treatment, takewritten for health professionals. For more information, call 1-833-ZEPOSIA Before you start treatment with ZEPOSIA, your healthcare providerthe next scheduled dose the following day. (1-833-937-6742) or go toZEPOSIA.com.may give you a chicken pox (Varicella Zoster Virus) vaccine if you have not had one before. Manufactured for: Celgene Corporation, Summit, NJ 07901have had chickenpox or have received the vaccine for chickenpox. YourWhat are the possible side effects of ZEPOSIA? Patent: www.celgene.com/therapieshealthcare provider may do a blood test for the chickenpox virus. YouZEPOSIA can cause serious side effects, including:may need to get the full course of the vaccine for chickenpox and thenSeeWhat is the most important information I should know wait 1 month before you start taking ZEPOSIA. about ZEPOSIA?ZEPOSIA is a trademark of Celgene, a Bristol-Myers Squibb Company.September 20202020 Bristol-Myers Squibb Company ZEP_PT_BS_v.002_09/20201'