b'IMPORTANT FACTS (CONTD)Do not take ZEPOSIA if you:Do not stop taking ZEPOSIA without talking with your healthcarehave had a heart attack, chest pain (unstable angina), stroke or mini- providerrst.stroke (transient ischemic attack or TIA), or certain types of heart failure Do not skip a dose.in the last 6 months.Start taking ZEPOSIA with a 7-day starter pack. have or have had a history of certain types of an irregular or abnormal If you miss 1 or more days of your ZEPOSIA dose during therst 14 days heartbeat (arrhythmia) that is not corrected by a pacemaker. of treatment, talk to your healthcare provider. You will need to begin withhave untreated, severe breathing problems during your sleepanother ZEPOSIA 7-day starter pack.(sleep apnea).If you miss a dose of ZEPOSIA after therst 14 days of treatment, taketake certain medicines called monoamine oxidase (MAO) inhibitors (e.g.,the next scheduled dose the following day.selegiline, phenelzine, linezolid). What are the possible side effects of ZEPOSIA (ozanimod)?Talk to your healthcare provider before taking ZEPOSIA if you have any ofZEPOSIA can cause serious side effects, including:these conditions or do not know if you have any of these conditions.See What is the most important information I should know Before taking ZEPOSIA, tell your healthcare provider about all of yourabout ZEPOSIA?medical conditions, including if you: have a fever or infection, or you are unable toght infections due to a liver problems. ZEPOSIA may cause liver problems. Your healthcare disease or take or have taken medicines that lower your immune system. provider will do blood tests to check your liver before you start takingreceived a vaccine in the past 30 days or are scheduled to receive aZEPOSIA. Call your healthcare provider right away if you have any of the vaccine. ZEPOSIA may cause vaccines to be less effective. following symptoms: Before you start treatment with ZEPOSIA, your healthcare provider mayounexplained nausea oloss of appetitegive you a chicken pox (Varicella Zoster Virus) vaccine if you have notovomiting olowing of the whites of youryelhad one before. ostomach area (abdominal) pain eyes or skin have had chickenpox or have received the vaccine for chickenpox. Yourotiredness odark colored urinehealthcare provider may do a blood test for the chickenpox virus. You increased blood pressure. Your healthcare provider should check your may need to get the full course of the vaccine for chickenpox and thenblood pressure during treatment with ZEPOSIA. A sudden, severe wait 1 month before you start taking ZEPOSIA (ozanimod). increase in blood pressure (hypertensive crisis) can happen when youhave a slow heart rate. eat certain foods that contain high levels of tyramine. See How should Ihave an irregular or abnormal heartbeat (arrhythmia). take ZEPOSIA? section for more information. have a history of a stroke.breathing problems. Some people who take ZEPOSIA have shortnesshave heart problems, including a heart attack or chest pain. of breath. Call your healthcare provider right away if you have new orhave high blood pressure. worsening breathing problems. have liver problems.a problem with your vision called macular edema. Your risk for macularhave breathing problems, including during your sleep. edema is higher if you have diabetes or have had an in ammation ofhave eye problems, especially an in ammation of the eye called uveitis. your eye called uveitis. Your healthcare provider should test your visionhave diabetes. before you start taking ZEPOSIA if you are at higher risk for macularare pregnant or plan to become pregnant. ZEPOSIA may harm youredema or at any time you notice vision changes during treatment with unborn baby. Talk with your healthcare provider if you are pregnantZEPOSIA. Call your healthcare provider right away if you have any of the or plan to become pregnant. If you are a female who can becomefollowing symptoms:pregnant, you should use effective birth control during your treatmentoblurriness or shadows in theoa blind spot in the center of with ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Talk withcenter of your vision your visionyour healthcare provider about what birth control method is right for youosensitivity to light ounusually colored visionduring this time. Tell your healthcare provider right away if you become swelling and narrowing of blood vessels in your brain. A condition pregnant while taking ZEPOSIA or if you become pregnant withincalled PRES (Posterior Reversible Encephalopathy Syndrome) is a 3 months after you stop taking ZEPOSIA. are breastfeeding or plan to breastfeed. It is not known if ZEPOSIArare condition that has happened with ZEPOSIA and with drugs in the passes into your breast milk. Talk to your healthcare provider about thesame class. Symptoms of PRES usually get better when you stop taking best way to feed your baby if you take ZEPOSIA.ZEPOSIA. If left untreated, it may lead to a stroke. Your healthcare Tell your healthcare provider about all the medicines you take or haveprovider will do a test if you have any symptoms of PRES. Call your recently taken, including prescription and over-the-counter medicines,healthcare provider right away if you have any of the following symptoms:osudden severe headache o vitamins, and herbal supplements. Using ZEPOSIA with other medicinessudden loss of vision or otherosudden confusioncan cause serious side effects. Especially tell your healthcare provider ifchanges in your visionyou take or have taken: oseizure medicines that affect your immune system, such as alemtuzumabsevere worsening of multiple sclerosis (MS) after stopping ZEPOSIA. medicines to control your heart rhythm (antiarrhythmics), or heart beat When ZEPOSIA is stopped, symptoms of MS may return and becomeCYP2C8 inducers such as rifampin worse compared to before or during treatment. Always talk to your healthcare provider before you stop taking ZEPOSIA for any reason. Tell CYP2C8 inhibitors such as gem brozil (medicine to treat high fat in your blood) your healthcare provider if you have worsening symptoms of MS afteropioids (pain medicine) stopping ZEPOSIA. medicines to treat depression The most common side effects of ZEPOSIA can include: medicines to treat Parkinsons diseaseupper respiratory tract infections medicines to control your heart rate and blood pressure (beta blocker elevated liver enzymes medicines and calcium channel blocker medicines)low blood pressure when you stand up (orthostatic hypotension)You should not receive live vaccines during treatment with ZEPOSIA, painful and frequent urination (signs of urinary tract infection)for at least 1 month before taking ZEPOSIA and for 3 months after you back painstop taking ZEPOSIA. Vaccines may not work as well when given during high blood pressuretreatment with ZEPOSIA.Talk with your healthcare provider if you are not sure if you take any of headachethese medicines. Know the medicines you take. Keep a list of them to showThese are not all of the possible side effects of ZEPOSIA. For more your healthcare provider and pharmacist when you get a new medicine. information, ask your healthcare provider or pharmacist. Call your How should I take ZEPOSIA? healthcare provider for medical advice about side effects. You may You will receive a 7-day starter pack. You must start ZEPOSIA by slowlyreport side effects to FDA at 1-800-FDA-1088.increasing doses over therst week. Follow the dose schedule of:General information about the safe and effective use of ZEPOSIA.Days 1-4: 0.23 mg 1 time a day; Days 5-7: 0.46 mg 1 time a day; Days 8Medicines are sometimes prescribed for purposes other than those listed and thereafter: 0.92 mg 1 time a day. This may reduce the risk of slowingin a Medication Guide. Do not take ZEPOSIA for conditions for which it of the heart rate. was not prescribed. Do not give ZEPOSIA to other people, even if theyTake ZEPOSIA exactly as your healthcare provider tells you to take it. have the same symptoms you have. It may harm them. You can askTake ZEPOSIA 1 time each day. your healthcare provider or pharmacist for information about ZEPOSIASwallow ZEPOSIA capsules whole. that is written for health professionals. For more information, callTake ZEPOSIA with or without food. 1-833-ZEPOSIA (1-833-937-6742) or go to ZEPOSIA.com. Avoid certain foods that are high (over 150 mg) in tyramine such asThis is a brief summary of the most important information about ZEPOSIA.aged, fermented, cured, smoked and pickled foods. Eating these foods while taking ZEPOSIA may increase your blood pressure.ZEPOSIA is a registered trademark of Celgene Corporation, aE BPrOisStoIAl-M e ibb Z isy ae rrse Sgqisuteibrbed C tormadpeamnay.r Ak voof nCeexlg isn ae r Ceogrisptoerraetdio tnra, ad eBmrisatrokl -oMf Byeiorsg Seqnu. o 2m0p2a1 nByr.i sAtvool-nMeyxerissSaq reugibisbt eCroemd ptraandye. mPrainrkte odfBini othgee nU. SA. 2084-US-2100962 07/21C2021 Bristol-Myers Squibb Company. All rights reserved. Printed in the USA. 2084-US-2100220 04/21'