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).What is the most important information I should know abouthave had chickenpox or have received the vaccine for chickenpox.What are the possible side effects of ZEPOSIA (ozanimod)?ZEPOSIA (ozanimod)? Your healthcare provider may do a blood test for the chickenpoxZEPOSIA can cause serious side effects, including:ZEPOSIA may cause serious side effects, including: virus. You may need to get the full course of the vaccine forSee What is the most important information I should know 1.Infections. ZEPOSIA can increase your risk of serious infectionschickenpox and then wait 1 month before you start takingabout ZEPOSIA?that can be life-threatening and cause death. ZEPOSIA lowers theZEPOSIA (ozanimod). liverproblems.ZEPOSIAmaycauseliverproblems. Your number of white blood cells (lymphocytes) in your blood. This willhave a slow heart rate. healthcare provider will do blood tests to check your liver before usually go back to normal within 3 months of stopping treatment.have an irregular or abnormal heartbeat (arrhythmia). you start taking ZEPOSIA. Call your healthcare provider right away Your healthcare provider may do a blood test of your white bloodhave a history of a stroke. if you have any of the following symptoms:cells before you start taking ZEPOSIA. have heart problems, including a heart attack or chest pain.unexplained nausealoss of appetiteCall your healthcare provider right away if you have any of thehave high blood pressure.vomitingyellowing of the whites of following symptoms of an infection during treatment withhave liver problems.stomach area (abdominal)your eyes or skinZEPOSIA and for 3 months after your last dose of ZEPOSIA: have breathing problems, including during your sleep. paindark colored urinehave eye problems, especially an inflammation of the eyefeverrash called uveitis.tiredness feeling very tiredheadache with fever, neckhave diabetes. increased blood pressure.Your healthcare provider should checku-like symptoms stiffness, sensitivity toare pregnant or plan to become pregnant. ZEPOSIA may harmyour blood pressure during treatment with ZEPOSIA. A sudden,cough light, nausea or confusionyour unborn baby. Talk with your healthcare provider if you aresevere increase in blood pressure (hypertensive crisis) can happen (these may be symptoms ofpregnant or plan to become pregnant. If you are a female whowhen you eat certain foods that contain high levels of tyramine.painful and frequentmeningitis, an infection ofcan become pregnant, you should use effective birth controlSee How should I take ZEPOSIA? section for more information.urination (signs of a urinarythe lining around your brainduring your treatment with ZEPOSIA and for 3 months after youbreathing problems.Some people who take ZEPOSIA have tract infection) and spine) stop taking ZEPOSIA. Talk with your healthcare provider aboutshortness of breath. Call your healthcare provider right away if Your healthcare provider may delay starting or may stop yourwhat birth control method is right for you during this time. Tellyou have new or worsening breathing problems.ZEPOSIA treatment if you have an infection. your healthcare provider right away if you become pregnant whilea problem with your vision called macular edema.Your risk 2.Slow heart rate (also known as bradyarrhythmia) when youtaking ZEPOSIA or if you become pregnant within 3 months afterfor macular edema is higher if you have diabetes or have had an start taking ZEPOSIA.ZEPOSIA may cause your heart rate toyou stop takingZEPOSIA. inammation of your eye called uveitis. Your healthcare provider temporarily slow down, especially during the rst 8 days that youare breastfeeding or plan to breastfeed. It is not known if ZEPOSIAshould test your vision before you start taking ZEPOSIA if you are take ZEPOSIA. You will have a test to check the electrical activitypasses into your breast milk. Talk to your healthcare providerat higher risk for macular edema or at any time you notice vision of your heart called an electrocardiogram (ECG) before you takeabout the best way to feed your baby if you take ZEPOSIA. changes during treatment with ZEPOSIA. Call your healthcare your rst dose of ZEPOSIA. Call your healthcare provider if youTell your healthcare provider about all the medicines you take orprovider right away if you have any of the following symptoms:experience the following symptoms of slow heart rate: have recently taken, including prescription and over-the-counter blurriness or shadows in the a blind spot in the center ofdizzinessshortness of breath medicines, vitamins, and herbal supplements. Using ZEPOSIA withcenter of your vision your vision lightheadednessconfusion other medicines can cause serious side effects. Especially tell your sensitivity to lightunusually colored vision feeling like your heart is chest pain healthcare provider if you take or have taken: swelling and narrowing of blood vessels in your brain.beating slowly or skipping tiredness medicines that affect your immune system, such as alemtuzumab Acondition called PRES (Posterior Reversible Encephalopathy beats medicines to control your heart rhythm (antiarrhythmics), orSyndrome) is a rare condition that has happened with ZEPOSIA Follow directions from your healthcare provider when startingheart beat and with drugs in the same class. Symptoms of PRES usually get strong CYP2C8 inhibitors such as gembrozil or clopidogrel better when you stop taking ZEPOSIA. If left untreated, it may lead ZEPOSIA and when you miss a dose. See How should I takemedicinesthatinhibitbreastcancerresistanceproteinto a stroke. Your healthcare provider will do a test if you have any ZEPOSIA?. transporters, such as cyclosporine and eltrombopag symptoms of PRES. Call your healthcare provider right away if you See What are the possible side effects of ZEPOSIA? for moreCYP2C8 inducers such as rifampin have any of the following symptoms:information about side effects. opioids (pain medicine)sudden severe headachesudden loss of vision or other medicines to treat depressionsudden confusion changes in your visionWhat is ZEPOSIA? medicines to treat Parkinsons diseaseseizureYou should not receive livevaccines during treatment with ZEPOSIA,severe worsening of multiple sclerosis (MS) after stopping ZEPOSIA is a prescription medicine used to treat relapsing formsfor at least 1 month before taking ZEPOSIA and for 3 months after youZEPOSIA.When ZEPOSIA is stopped, symptoms of MS may return of multiple sclerosis (MS), to include clinically isolated syndrome,stop taking ZEPOSIA. Vaccines may not work as well when given duringand become worse compared to before or during treatment. relapsing-remitting disease, and active secondary progressivetreatment with ZEPOSIA. Always talk to your healthcare provider before you stop taking disease, in adults. ZEPOSIA for any reason. Tell your healthcare provider if you have It is not known if ZEPOSIA is safe and effective in children. Talk with your healthcare provider if you are not sure if you take anyworsening symptoms of MS after stopping ZEPOSIA.of these medicines. Know the medicines you take. Keep a list of themallergic reactions.Call your healthcare provider if you have to show your healthcare provider and pharmacist when you get asymptoms of an allergic reaction, including a rash, itchy hives, or Do not take ZEPOSIA if you: newmedicine. swelling of the lips, tongue or face.have had a heart attack, chest pain (unstable angina), stroke orThe most common side effects of ZEPOSIA can include:mini-stroke (transient ischemic attack or TIA), or certain types ofHow should I take ZEPOSIA? upper respiratory tract infectionsheart failure in the last 6 months. You will receive a 7-day starter pack. You must start ZEPOSIAelevated liver enzymeshave or have had a history of certain types of an irregular orby slowly increasing doses over the first week. Follow thelow blood pressure when you stand up (orthostatic hypotension)abnormal heartbeat (arrhythmia) that is not corrected by adose schedule of: Days 1-4: 0.23 mg 1 time a day; Days 5-7: 0.46 mgpainful and frequent urination (signs of urinary tractinfection)pacemaker. 1time a day; Days 8 and thereafter: 0.92 mg 1 time a day. This mayback painhave untreated, severe breathing problems during your sleepreduce the risk of slowing of the heart rate.high blood pressure(sleep apnea). Take ZEPOSIA exactly as your healthcare provider tells you to take it. These are not all of the possible side effects of ZEPOSIA. For more take certain medicines called monoamine oxidase (MAO) inhibitorsTake ZEPOSIA 1 time each day. information, ask your healthcare provider or pharmacist. Call your (e.g., selegiline, phenelzine, linezolid). Swallow ZEPOSIA capsules whole. healthcare provider for medical advice about side effects. You may Talk to your healthcare provider before taking ZEPOSIA if you haveTake ZEPOSIA with or without food. report side effects to FDA at1-800-FDA-1088.any of these conditions or do not know if you have any of theseAvoid certain foods that are high (over 150 mg) in tyramine such conditions. as aged, fermented, cured, smoked and pickled foods. Eating theseGeneral information about the safe and effective use of ZEPOSIA. foods while taking ZEPOSIA may increase your blood pressure. Medicines are sometimes prescribed for purposes other than those Before taking ZEPOSIA, tell your healthcare provider about all ofDo not stop taking ZEPOSIA without talking with your healthcarelisted in a Medication Guide. Do not take ZEPOSIA for conditions for your medical conditions, including if you: provider rst. which it was not prescribed. Do not give ZEPOSIA to other people, even have a fever or infection, or you are unable to ght infectionsDo not skip a dose. if they have the same symptoms you have. It may harm them. You due to a disease or take or have taken medicines that lower yourStart taking ZEPOSIA with a 7-day starter pack. can ask your healthcare provider or pharmacist for information about immune system. If you miss 1 or more days of your ZEPOSIA dose during the rstZEPOSIA that is written for health professionals. For more information, received a vaccine in the past 30 days or are scheduled to receive 14days of treatment, talk to your healthcare provider. You willcall 1-833-ZEPOSIA (1-833-937-6742) or go to ZEPOSIA.com.a vaccine. ZEPOSIA may cause vaccines to be less effective. need to begin with another ZEPOSIA 7-day starter pack. Manufactured for: Celgene Corporation, Summit, NJ 07901Before you start treatment with ZEPOSIA, your healthcare providerIf you miss a dose of ZEPOSIA after the rst 14 days of treatment,Patent: www.celgene.com/therapiesmay give you a chicken pox (Varicella Zoster Virus) vaccine if youtake the next scheduled dose the following day.have not had one before.ZEPOSIA is a trademark of Celgene, a Bristol-Myers Squibb Company.March 20202020 Bristol-Myers Squibb Company ZEP_PT_BS_v.001_03/2020 1'