b'B:16"T:15.75"S:15.25"FOR ADULTS WITH RELAPSING MULTIPLE SCLEROSIS \x10MS\x0f 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.BE READY FOR WHATS NEXThave 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:I takea once-daily pill.have a fever or infection, or you are unable toght infections due to a liver problems. ZEPOSIA may cause liver problems. Your healthcare ZEPOSIA, 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 And I take on G OA L tthhaattmmaatttteerrttoommeevaccine. ZEPOSIA may cause vaccines to be less effective. following symptoms: oloss of appetiteTWO YEAR DATA DESKTOP TWO YEAR DATA MOBILE ounexplained nauseaBefore you start treatment with ZEPOSIA, your healthcare provider may ONE YEAR DATA DESKTOP ONE YEAR DATA MOBILE give you a chicken pox (Varicella Zoster Virus) vaccine if you have notovomiting oy ellowing of the whites of yourhad one before. ostomach area (abdominal) pain eyes or skinAsk your MS healthcare team about ZEPOSIA today.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 you RELAPSEShave a slow heart rate. eat certain foods that contain high levels of tyramine. See How should I have an irregular or abnormal heartbeat (arrhythmia).RELAPSEShave a history of a stroke. take ZEPOSIA? section for more information. have heart problems, including a heart attack or chest pain.breathing problems. Some people who take ZEPOSIA have shortnesshave high blood pressure. of breath. Call your healthcare provider right away if you have new orhave liver problems. worsening breathing problems. a problem with your vision called macular edema. Your risk for macular ZEPOSIA is scienti cally proven to reduce MS relapses ZEPOSIA had have breathing problems, including during your sleep. edema is higher if you have diabetes or have had an in ammation of People who tookPeople who took ZEPOSIA had your eye called uveitis. Your healthcare provider should test your vision People who took ZEPOSIA had People who took ZEPOSIA had have eye problems, especially an in ammation of the eye called uveitis. have 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 becomeS:10" T:10.5" B:10.75"In a ONE\x04YEAR study: In a separate TWO\x04YEAR study: pregnant while taking ZEPOSIA or if you become pregnant within swelling and narrowing of blood vessels in your brain. A conditionthan those who took athan those who took acalled PRES (Posterior Reversible Encephalopathy Syndrome) is a than those who took athan those who took a3 months after you stop taking ZEPOSIA. rare condition that has happened with ZEPOSIA and with drugs in the People who took ZEPOSIA(ozanimod) hadPeople who took ZEPOSIA had 38% fewer are breastfeeding or plan to breastfeed. It is not known if ZEPOSIA LEADING INJECTABLELEADING INJECTABLEsame class. Symptoms of PRES usually get better when you stop taking LEADING INJECTABLE MEDICINE LEADING INJECTABLE MEDICINE passes into your breast milk. Talk to your healthcare provider about the 48% fewer relapses than a leading injectablerelapses than a leading injectable. medicine (Avonex).*MEDICINE MEDICINE ZEPOSIA. If left untreated, it may lead to a stroke. Your healthcare best way to feed your baby if you take ZEPOSIA. 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 headachevitamins, and herbal supplements. Using ZEPOSIA with other medicineso sudden loss of vision or otherchanges in your visionosudden confusionSee the full study results can cause serious side effects. Especially tell your healthcare provider ifoseizureyou take or have taken:Scan this code with your phones camera or visit ZEPOSIA.com/resultsmedicines 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 CYP2C8 inhibitors such as gem brozil (medicine to treat high fat inhealthcare provider before you stop taking ZEPOSIA for any reason. Tell *Avonex (interferon beta-1a).your blood) your healthcare provider if you have worsening symptoms of MS after opioids (pain medicine) stopping ZEPOSIA.One-year study: People taking ZEPOSIA had an Annualized Relapse Rate (ARR) of 0.181 vs 0.350 with a leading injectable. A total of 895 people medicines to treat depression The most common side effects of ZEPOSIA can include:were studied (ZEPOSIA 447, a leading injectable 448). Two-year study: People taking ZEPOSIA had an ARR of 0.172 vs 0.276 with a leading injectable. A total of 874 people were studied (ZEPOSIA 433, a leading injectable 441).medicines to treat Parkinsons diseaseupper respiratory tract infections medicines to control your heart rate and blood pressure (beta blocker elevated liver enzymes IMPORTANT FACTS medicines and calcium channel blocker medicines)of people were ng or may stop ylow blood pressure when you stand up (orthostatic hypotension)The information below does not take the place of talking with your healthcareVS of peopleour ZEPOSIAof people were VS of people painful and frequent urination (signs of urinary tract infection)Your healthcare provider may delay starti You should not receive live vaccines during treatment with ZEPOSIA, professional. Only your healthcare professional knows the speci cs oftreatment if you have an infection. VS for at least 1 month before taking ZEPOSIA and for 3 months afaback painwho took ter you who took a of people of people were(ozanimod)f peopleof people werehigh blood pressureyour condition and how ZEPOSIA VS mayt into your overall2.Slow heart rate (also known as bradyarrhythmia) when you start takingstop taking ZEPOSIA. Vaccines may not work as well when given during o who took a treatment with ZEPOSIA. LEADING therapy. Talk to your healthcare professional if you have any questions aboutLEADING ZEPOSIA (pronounced zeh-poe-see-ah). who took a ZEPOSIA. ZEPOSIA may cause your heart rate to temporarily slowTalk with your healthcare provider if you are not sure if you take any of headacheINJECTABLELEADINGINJECTABLEThese are not all of the possible side effects of ZEPOSIA. For more down, especially during therst 8 days that you take ZEPOSIA. You LEADINGwill have a test to check the electrical activity of your heart called anthese medicines. Know the medicines you take. Keep a list of them to show What is the most important information I should know aboutwith MEDICINE INJECTABLEwith ZEPOSIA MEDICINE information, ask your healthcare provider or pharmacist. Call your ZEPOSIA (ozanimod)? ZEPOSIA your healthcare provider and pharmacist when you get a new medicine.INJECTABLEelectrocardiogram (ECG) before you take yourrst dose of ZEPOSIA. ZEPOSIA may cause serious side effects, including: with ZEPOSIA MEDICINE healthcare provider for medical advice about side effects. You may How should I take ZEPOSIA?with ZEPOSIA MEDICINE Call your healthcare provider if you experience the following symptomsYou will receive a 7-day starter pack. You must start ZEPOSIA by slowlyreport side effects to FDA at 1-800-FDA-1088.1. I nfections. ZEPOSIA can increase your risk of serious infections that canof slow heart rate:be life-threatening and cause death. ZEPOSIA lowers the number of whiteodizziness oshortness of breath increasing doses over therst week. Follow the dose schedule of:General information about the safe and effective use of ZEPOSIA.blood cells (lymphocytes) in your blood. This will usually go back to normalolightheadedness oconfusion 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 within 3 months of stopping treatment. Your healthcare provider may do ao feeling like your heart is beatingochest pain 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 blood test of your white blood cells before you start taking ZEPOSIA. slowly or skipping beats otiredness of the heart rate. was not prescribed. Do not give ZEPOSIA to other people, even if they Call your healthcare provider right away if you have any of the following Take ZEPOSIA exactly as your healthcare provider tells you to take it. have the same symptoms you have. It may harm them. You can ask symptoms of an infection during treatment with ZEPOSIA and forFollow directions from your healthcare provider when starting ZEPOSIA Take ZEPOSIA 1 time each day. your healthcare provider or pharmacist for information about ZEPOSIA 3 months after your last dose of ZEPOSIA: and when you miss a dose. See How should I take ZEPOSIA?.Swallow ZEPOSIA capsules whole. that is written for health professionals. For more information, call ofever orash See What are the possible side effects of ZEPOSIA? for more Take ZEPOSIA with or without food. 1-833-ZEPOSIA (1-833-937-6742) or go to ZEPOSIA.com.ofeeling very tired o headache with fever, neckinformation about side effects. LESIONSAvoid certain foods that are high (over 150 mg) in tyramine such asThis is a brief summary of the most important information about ZEPOSIA.o u-like symptoms stiffness, sensitivity to light,LESIONS aged, fermented, cured, smoked and pickled foods. Eating these foods What is ZEPOSIA?ocough nausea or confusion (these may ZEPOSIA is a prescription medicine used to treat adults with relapsingwhile taking ZEPOSIA may increase your blood pressure.o painful and frequent urinationbe symptoms of meningitis, anforms of multiple sclerosis (MS), to include clinically isolated syndrome,ZEPOSIA is a registered trademark of Celgene Corporation, (signs of a urinary tract infection) infection of the lining around yourrelapsing-remitting disease, and active secondary progressive disease.a Bristol-Myers Squibb Company. Avonex is a registered trademark of Biogen. brain and spine) It is not known if ZEPOSIA is safe and effective in children.2021 Bristol-Myers Squibb Company. 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