Advertising revenue supports our not-for-profit mission. Not all possible drug interactions are listed here. These are not all of the possible side effects of ZEPOSIA. -For the treatment of moderately to severely active ulcerative colitis. Ozanimod comes in a 7-day starter pack containing capsules of different colors and strengths. MS trials (4%): Upper respiratory infection, liver enzyme elevations, orthostatic hypotension, urinary tract infection, back pain, hypertension. Overdose and LD50 information for ozanimod is not readily available in the literature. Serious Interactions. This content does not have an Arabic version. These medications may interact and cause very harmful effects. You are about to leave this Bristol Myers Squibbsite. Download these 7 questions or send them to yourself for your nextappointment. . SELECTED STEROIDS . Ozanimod can lower the peripheral lymphocyte count for 3 months after discontinuation. For Healthcare Professionals Applies to ozanimod: oral capsule. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. ZEPOSIA (ozanimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. What are the side effects of Zeposia (Ozanimod)? "Product Information. Portions of this document last updated: Dec. 01, 2022. Your doctor may occasionally change your dose. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Eating these foods while taking this medicine can raise your blood pressure. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including: weakness on one (1) side of your body, changes in your vision, changes in your thinking or memory, confusion, changes in your personality, loss of coordination in your arms or legs, decreased strength, and/or problems with balance. Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. View chapter Purchase book All other trademarks are the property of their respective owner. Void where prohibited by law, taxed, or restricted, The Program cannot be combined with any other offer, rebate, coupon, or free trial, The Program is not conditioned on any past, present or future purchase, including refills, Bristol Myers Squibb reserves the right to rescind, revoke, or amend this Program at any time without notice, are or plan to become pregnant or if you become pregnant within. This includes prescription and over-the-counter medicines, vitamins, and herbal products. ozanimod ozanimod decreases effects of hepatitis b vaccine by immunosuppressive effects risk of infection. This website is best viewed using the horizontal display on your tablet device. Uses Ozanimod is used to treat adults with relapsing forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people Medication Guide Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Use of drugs with prolonged immune effects during this period can cause additive immunosuppressive effects and increase the risk of infection. No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. Last updated on Nov 13, 2022. Call your healthcare provider if you have symptoms of an allergic reaction, including a rash, itchy hives, or swelling of the lips, tongue or face. This is not a complete list of side effects and others may occur. Sign up to receive the latest ZEPOSIA details, stories from real people taking ZEPOSIA, and more from ZEPOSIA 360Support. Continue reading. Why does ozanimod slow down your heart rate. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. Along with its needed effects, a medicine may cause some unwanted effects. [3] [4] [5] [6] It acts as a sphingosine-1-phosphate (S1P) receptor agonist, sequestering lymphocytes to peripheral lymphoid organs and away from their sites of chronic inflammation. Multiple Sclerosis (MS): ZEPOSIA (ozanimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting . Applies to the following strengths: 0.23 mg-0.46 mg; 0.92 mg; 0.23 mg-0.46 mg-0.92 mg Usual Adult Dose for: Multiple Sclerosis Ulcerative Colitis Additional dosage information: Renal Dose Adjustments Liver Dose Adjustments Dose Adjustments Precautions Dialysis Check with your doctor immediately if any of the following side effects occur: More common Body aches or pain cough or hoarseness dark-colored urine difficulty in breathing ear congestion fever or chills general feeling of tiredness or weakness headache light-colored stools loss of voice lower back or side pain painful or difficult urination Dosage form: oral capsule (0.23 mg-0.46 mg; 0.23 mg-0.46 mg-0.92 mg; 0.92 mg) Zeposia (ozanimod) was approved for the treatment of adults with RRMS by: Which is the best infusion medicine for MS? Patients are not eligible for the medical assessment benefit offer if they have insurance coverage for their prescription or medical assessment through a state or federal healthcare program, or reside in Massachusetts, Minnesota, or Rhode Island. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV. Your doctor may change your treatment plan if you also use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol. ulcerative colitis, an inflammatory condition of the intestines, a decreased number of lymphocytes in the blood, orthostatic hypotension, a form of low blood pressure, fluid retention in the legs, feet, arms or hands, atrioventricular block, a type of slow heart rhythm disorder, progressive multifocal leukoencephalopathy, a type of brain infection, a type of brain disorder called posterior reversible encephalopathy syndrome. The FDA-approved infusion medications for MS are: 1 alemtuzumab (Lemtrada) 2 mitoxantrone hydrochloride 3 natalizumab (Tysabri) 4 ocrelizumab (Ocrevus) What are the side effects of multiple sclerosis medication? Tell your doctor if you become pregnant. chest pain. High levels of liver transaminase enzymes. Especially tell your healthcare provider if you take or have taken: You should not receive live vaccines during treatment with ZEPOSIA, for at least 1 month before taking ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Please see the full Prescribing Information and While you are taking ozanimod, a "live" vaccine may not fully protect you from disease and you could develop an infection. Call your healthcare provider for medical advice about side effects. If you get severe headaches, nosebleeds, difficulty breathing, vision changes, irregular heartbeat, or chest pain while taking Zeposia (ozanimod), stop taking it and get medical attention right away. Serious side effects of Ozanimod include: hives, difficulty breathing, swelling of the face, lips, tongue, or throat, unexplained nausea loss of appetite vomiting yellowing of the whites of the eyes or skin stomach area (abdominal) pain dark colored urine tiredness increased blood pressure breathing problems You may get infections more easily, even serious or fatal infections. How does it work? Before your first dose, your heart function will be checked using an electrocardiograph or ECG (sometimes called an EKG). Ozanimod is used only if you have a specific genotype. Please see full Prescribing Information, including MedicationGuide. View complete list of side effects. UC trials ( 4%): Liver enzyme elevations, upper respiratory infection, headache. Ozanimod is a novel, oral, small-molecule S1P 1 and . The NOAEL dose is 0.164 mg/kg/d for monkeys, and the human equivalent dose to this is about 0.053 mg/kg/day. other side effects may include: serious infections, slow heart rate (bradycardia - this can cause dizziness, lightheadedness, shortness of breath, or fatigue), shortness of breath, eye changes called macular edema (your eyes will be followed closely by an ophthalmologist if you have uveitis or diabetes mellitus), posterior reversible You may report side effects to FDA at 1-800-FDA-1088 1-800-FDA-1088. Applies to ozanimod: oral capsules. Use effective birth control while using ozanimod and for at least 3 months after your last dose. Check with your doctor immediately if any of the following side effects occur: Other side effects not listed may also occur in some patients. Avoid foods high in tyramine (aged, fermented, cured, smoked and pickled foods). Ozanimod is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). Always ask your doctor before you stop taking ozanimod for any reason. Some heart rhythm medications can cause unwanted or dangerous effects when used with ozanimod. Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting. Toxicity. cough or hoarseness. This survey is being conducted by the WebMD marketing sciences department. . Why does ozanimod slow down your heart rate? Ozanimod, sold under the brand name Zeposia, is an immunomodulatory medication for the treatment of relapsing multiple sclerosis and ulcerative colitis. Any links to other sites are provided merely as a convenience to users of this website. ZEPOSIA, ZEPOSIA 360 Support, and ZEPOSIA logo are trademarks of Celgene Corporation, a Bristol Myers Squibb company. These include: If you get an infection, further doses may be delayed until your infection clears up. During clinical studies, people who took ZEPOSIA and those who took a leading injectable medicine were asked to report side effects that they experienced. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Vaccines may not work as well when given during treatment withZEPOSIA. You are being redirected to another Bristol Myers Squibbsite. Get emergency medical help if you have signs of an allergic reaction: hives, rash; difficult breathing; swelling of your face, lips, tongue,. Talk to your healthcare provider about the best way to feed your baby if you take ZEPOSIA, medicines that affect your immune system, such as alemtuzumab, medicines to control your heart rhythm (antiarrhythmics), or heartbeat, CYP2C8 inhibitors such as gemfibrozil (medicine to treat high fat in your blood), opioids (pain medicine), medicines to treat depression, and medicines to treat Parkinsons disease, medicines to control your heart rate and blood pressure (beta blocker medicines and calcium channel blocker medicines), yellowing of the whites of your eyes or skin, blurriness or shadows in the center of your vision, a blind spot in the center of your vision, sudden loss of vision or other changes in your vision, low blood pressure when you stand up (orthostatic hypotension), painful and frequent urination (signs of urinary tract infection), The ZEPOSIA Co-pay Program is valid only for patients with commercial (private) insurance. Continue reading, The reason ozanimod may slow down your heart rate temporarily when you first start taking it is thought to be due to the action of ozanimod binding to one of the S1P receptors' subunits, S1P1R, which also has an effect of potassium channels in cardiac muscle cells. You may report side effects to FDA at 1-800-FDA-1088. However, many people have no side effects or only have minor side effects. You should not use ozanimod if you have a serious heart condition such as "AV block" or sick sinus syndrome and no pacemaker, or if you've recently had heart failure, a heart rhythm disorder, chest pain, heart attack, or stroke. Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine. If you experience any side effects while taking ZEPOSIA, be sure to talk to your doctor right away. All rights reserved. If you miss 1 or more doses in the first 2 weeks of treatment, you may need to start a new 7-day starter pack. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Call your doctor for medical advice about side effects. Back pain. Version: 4.02. 11 Its delayed absorption reduces effects that may occur after the first dose, such as heart rate changes. 1. slow heartbeats, chest pain, shortness of breath, feel like your heart is skipping beats, lightheadedness, cough, new or worsening shortness of breath, sudden confusion, severe headache, vision loss, seizure, pounding in your neck or ears, nausea, vomiting, upper stomach pain, loss of appetite, dark urine, Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. This benefit is available without obligation to continue with ZEPOSIA therapy, All Program payments are for the benefit of the patient only, Patients, pharmacists, and prescribers may not seek reimbursement from health insurance, health savings or flexible spending accounts, or any third party, for any part of the prescription or medical assessment benefit received by the patient through this Program, Patients acceptance of any Program benefit confirms that it is consistent with patients insurance and that patient will report the value received as may be required by his/her insurance provider, Program valid only in the United States and Puerto Rico. difficulty in breathing or swallowing. This may lower the risk of side effects. It is not known if ZEPOSIA passes into your breast milk. For more information, ask your healthcare provider orpharmacist. slow heartbeats, chest pain, shortness of breath, or feel like your heart is skipping beats; a light-headed feeling, like you might pass out; cough, new or worsening shortness of breath; sudden confusion, severe headache, vision loss, or a seizure; liver problems - nausea, vomiting, upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); changes in vision - blurred vision, increased sensitivity to light, seeing an unusual color in your vision, or having a blind spot or shadows in the center of your vision; or. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ozanimod on the baby. severe untreated sleep apnea (breathing stops during sleep). Is ozanimod a biologic? Tell your doctor right away if you develop any signs of an infection such as sore throat / cough. Ozanimod can have long lasting effects on your body, especially on your immune system. If you miss a dose after the first 2 weeks: Skip the missed dose and use your next dose at the regular time. you should know that ozanimod may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. Multiple Sclerosis (MS): ZEPOSIA (ozanimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. allergic reactions. If you are a female who can become pregnant, talk to your healthcare provider about what birth control method is right for you during your treatment with ZEPOSIA and for 3 months after you stop taking ZEPOSIA. 2005 - 2022 WebMD LLC. This prevents the nerves from working properly and can lead to symptoms such as numbness, difficulty walking, and problems with vision and balance. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. What conditions does Ozanimod Oral treat? By By Here are the side effects that occurred in at least 4% of people, along with the percentage of people who experiencedeach. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Signs of a common cold. Common ozanimod side effects may include: headache, back pain; urination problems; high or low blood pressure; abnormal liver function tests; or cold symptoms such as stuffy nose, sneezing, sore throat. Some side effects may not be reported. symptoms of infection - fever, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light. This is not a complete list of side effects and others may occur. 4. Common side effects may include: headache, back pain; urination problems; high or low . This site complies with the HONcode standard for trustworthy health information: verify here. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Ozanimod is absorbed in the gastrointestinal tract after oral administration. You may be more likely to get a serious (possibly fatal) infection (such as bronchitis, herpes). Patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine, should have hepatic enzymes checked and ozanimod should be discontinued if significant liver injury is confirmed. for information on all of the side effects reported by those taking ZEPOSIA. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. ZEPOSIA was approved for multiple sclerosis (MS) by the Food and Drug Administration (FDA) on 03/25/2020. Your risk of infection could last for 3 months after you stop taking ozanimod. BMS has no responsibility for the content of such other sites and is not liable for any damages or injury arising from that content. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. feeling like your heart is beating slowly or skipping beats shortness of breath confusion chest pain tiredness have a fever or infection, or are unable to fight infections due to a disease, or take or have taken medicines that lower your immune system received a vaccine in the past 30 days or are scheduled to receive a vaccine. Medically reviewed by Alan Carter, Pharm.D. Ozanimod pregnancy and breastfeeding warnings. Common side effects of hepatitis B vaccines include: pain, redness and swelling at injection site . ozanimod oral Side Effects by Severity ZEPOSIA Side Effects by Likelihood and Severity COMMON side effects If experienced, these tend to have a Severe expression i an infection a. Brand name: Zeposia . These could be symptoms of a serious liver problem. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Davis Drug Guide PDF. This website is best viewed using the vertical display on your mobile device. In relapsing multiple sclerosis, the attacks on the nerve cells are followed by periods of recovery. Data sources include IBM Watson Micromedex (updated 2 Dec 2022), Cerner Multum (updated 7 Dec 2022), ASHP (updated 11 Nov 2022) and others. Talk to your MS healthcare team about the possible side effects of ZEPOSIA and ask if it mayberightforyou. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. ozanimod; procainamide; protein kinase inhibitors (e.g., ceritinib, crizotinib, imatinib, lapatinib, pazopanib, sunitinib) quinidine; quinine; -Day 8 and thereafter: 0.92 mg orally once a day Get emergency medical help if you have signs of an allergic reaction to ozanimod: hives, rash; difficult breathing; swelling of your face, lips, tongue, or throat. Serious side effects of Inotuzumab include: Black, tarry stools. The Cmax of ozanimod is 0.244 ng/mL 11 and is achieved at 6 to 8 hours after administration 7, reaching steady-state at about 102 hours after administration.The AUC is 4.46 ng*h/mL. Specific Populations You may need to receive the vaccine and then wait 1 month before taking this medicine. Vaccines may not work as well when given during treatment withZEPOSIA. Pregnancy Selected from data included with permission and copyrighted by First Databank, Inc. Humira, Stelara, Colazal, Pentasa, Dipentum, Azulfidine, Asacol, Rowasa, Lialda, Apriso. If you become pregnant while taking ZEPOSIA for MS, tell your healthcare provider right away and enroll in the ZEPOSIA Pregnancy Registry by calling, are breastfeeding or plan to breastfeed. 44 The rates of response at week 6 among patients receiving ustekinumab at a dose of either 130 mg or 6 mg/kg were significantly higher than the rate among . The Side-by-Side format only applies to the Protocol section of the study. Tell your doctor if you have slow heartbeats, chest pain, shortness of breath, feeling like your heart is skipping beats. This reduces how responsive the cardiac cells are and reduces their firing rate, which slows down the heart. For adults with relapsing multiple sclerosis, have had a heart attack, chest pain (unstable angina), stroke or, have or have had a history of certain types of an irregular or abnormal heartbeat (arrhythmia) that is not corrected by a pacemaker, have untreated, severe breathing problems during your sleep (sleep apnea), take certain medicines called monoamine oxidase (MAO) inhibitors (such as selegiline, phenelzine, linezolid), painful and frequent urination (signs of a urinary tract infection), headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine), feeling like your heart is beating slowly or skipping beats, have a fever or infection, or are unable to fight infections due to a disease, or take or have taken medicines that lower your immune system, received a vaccine in the past 30 days or are scheduled to receive a vaccine. symptoms of infection -- fever, tiredness, cough, rash, increased urination, pain or burning when you urinate, neck stiffness, increased sensitivity to light. WebMD does not provide medical advice, diagnosis or treatment. You should not use ozanimod if you are allergic to it, or if you have certain serious heart conditions, especially: recent (within the past 6 months) heart failure, heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other serious heart problem; "AV block" or sick sinus syndrome (unless you have a pacemaker); or. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Copyright 1996-2022 Cerner Multum, Inc. -For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease ZEPOSIA may harm your unborn baby. If you feel you are experiencing aside effect while taking ZEPOSIA,reach out to your healthcareprofessional. Take ozanimod exactly as prescribed by your doctor. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. Available for Android and iOS devices. Ozanimod can slow your heart rate when you start taking it. Find information on Ozanimod (Zeposia) in Davis's Drug Guide including dosage, side effects, interactions, nursing implications, mechanism of action, half life, administration, and more. Certain foods that contain very high amounts (more than 150 mg) of tyramine could cause high blood pressure while you're taking Zeposia (ozanimod). Does Ozanimod Oral interact with other medications? Upper respiratory tract infections and elevations in liver . The safety of ZEPOSIA was evaluated in 882 people during a one-year and two-year clinical study. ZEPOSIAa once-daily pill approved to treat adults with: Moderate to severe ulcerative colitis (UC), ZEPOSIA (ozanimod) Co-Pay Program Terms and Conditions. Gamma-glutamyl transferase increased, and. Orthostatic hypotension (decreases in blood pressure when standing up or sitting down) Urinary tract infection. How does it work? Progressive multifocal leukoencephalopathy (PML). Mayo Clinic on Incontinence - Mayo Clinic Press, NEW The Essential Diabetes Book - Mayo Clinic Press, NEW Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. You may get infections more easily, even serious or fatal infections. You may need to get the full course of the vaccine and wait 1 month before taking ZEPOSIA, have an irregular or abnormal heartbeat (arrhythmia), have or have had heart problems, including a heart attack or chest pain, have breathing problems, including during your sleep, have eye problems, especially an inflammation of the eye called uveitis, are or plan to become pregnant or if you become pregnant within 3 months after you stop taking ZEPOSIA. It is not known if this medicine is safe and effective in children. Side-effects For ozanimod Common or very common Bradycardia; hypertension; increased risk of infection; lymphopenia; postural hypotension Conception and contraception For ozanimod Exclude pregnancy before treatment; females of childbearing potential should use effective contraception during treatment and for 3 months after last dose. . Generic name: ozanimod [oh-ZAN-i-mod] Ask a doctor if it is safe to breastfeed while using this medicine. You may report side effects to the FDA at 1-800-FDA-1088. Aside from the nonspecific side effects of headache and nasopharyngitis (actually less than in placebo), there was some orthostatic hypotension reported on the first day of dosing more commonly with ozanimod. Available for Android and iOS devices. Monitor for respiratory effects (reductions in forced expiratory volume [FEV 1 ] and forced vital . 90% of people taking ZEPOSIA remained on treatment throughout the clinical studies. Ozanimod can slow your heart rate when you start taking it. Learn How Genetics Make Some Fans of Fear, Dr. Whyte's Book: Take Control of Your Cancer Risk, How Breast Cancer Changed My Life and Me, Health News and Information, Delivered to Your Inbox, Treating Opioid Use Disorder With Medications, Constipated? These are not all of the side effects that may occur. Select a condition to view a list of medication options. Your doctor may change your treatment plan if you also use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol. When the relapse is over, the symptoms may disappear completely, but some problems may also remain. 1998-2022 Mayo Foundation for Medical Education and Research (MFMER). The most common side effects of ZEPOSIA can include: upper respiratory tract infections low blood pressure when you stand up ( orthostatic hypotension) back pain Uses: Ulcerative Colitis (UC): ZEPOSIA is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults. Of those who stopped taking ZEPOSIA, 3% did so because of a side effect they experienced. Call your doctor for medical advice about side effects. DOSE TITRATION REGIMEN: Talk to your healthcare provider before taking ZEPOSIA if you have any of these conditions or do not know if you have any of these conditions. coughing up blood. Should I avoid certain foods while taking Ozanimod Oral? ZEPOSIA can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. What are the new drugs used for multiple sclerosis (MS). ZEPOSIA may cause vaccines to be less effective, before you start ZEPOSIA, your healthcare provider may give you a chickenpox (Varicella Zoster Virus) vaccine if you have not had one before, have had chickenpox or have received the vaccine for chickenpox. Such therapies often prove insufficient alone and highlight the need for more targeted MS treatments with reduced systemic side effect profiles. Call your healthcare provider for medical advice about side effects. What are the new drugs used for multiple sclerosis (MS)? Continue reading, Ozanimod (Zeposia) works quickly in people with MS, within a few months, although it may take up to a year for the full effects of significantly less disease progression, fewer relapses, and less brain atrophy than standard care to be seen. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. [5] Copyright 2022 IBM Watson Health. Minor/Significance Unknown. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. This content does not have an English version. This website is intended for U.S. residents 18 years of age orolder. You also should not use ozanimod if you have severe untreated sleep apnea. Tell your doctor if you have received any vaccine within the past 30 days, or if you are scheduled to receive a vaccine. Symptoms of PML get worse over days to weeks. Frequency not reported: Hypersensitivity[Ref], Frequency not reported: Cryptococcal meningitis (CM)[Ref], Common (1% to 10%): Back pain, arthralgia[Ref], Uncommon (0.1% to 1%): Macular edema[Ref], Common (1% to 10%): Urinary tract infection[Ref], Very common (10% or more): Aminotransferase elevations (e.g., alanine aminotransferase increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, hepatic enzyme increased, liver function test abnormal, transaminases increased) (10%)[Ref], Frequency not reported: Malignancies (e.g., melanoma, basal cell carcinoma, breast cancer, seminoma, cutaneous malignancies)[Ref], Very common (10% or more): Upper respiratory tract infection (e.g., nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, rhinitis, respiratory tract infection viral, viral upper respiratory tract infection, rhinorrhea, tracheitis, laryngitis) (26%), Common (1% to 10%): Dose-dependent reductions in absolute FEV1 and FVC[Ref], Frequency not reported: Severe exacerbation of disease (e.g., disease rebound)[Ref], Rare (0.01% to 0.1%): Progressive multifocal leukoencephalopathy (PML)[Ref], Common (1% to 10%): Hypertension (e.g., hypertension, essential hypertension, orthostatic hypertension), peripheral edema, Frequency not reported: Atrioventricular conduction delays[Ref], Frequency not reported: Rash, urticaria[Ref], Common (1% to 10%): Upper abdominal pain, nausea[Ref]. Medically reviewed by Philip Thornton, DipPharm. Ozanimod Dosage Medically reviewed by Drugs.com. We comply with the HONcode standard for trustworthy health information. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Ozanimod is a novel S1P (sphingosine-1-phosphate) receptor modulator used for the treatment of clinically isolated syndrome, relapsing-remitting, and secondary progressive forms of multiple sclerosis. Call your doctor for instructions. -Days 1 through 4: 0.23 mg orally once a day Tell your doctor if you have any signs of worsening MS. Common ozanimod side effects may include: cold symptoms such as stuffy nose, sneezing, sore throat. MAINTENANCE DOSE: 0.92 mg orally once daily starting on Day 8 If you stop taking ozanimod or miss a dose during the first 2 weeks, ask your doctor before you start taking the medicine again. All rights reserved. Continue reading for additional possible serious side effects of ZEPOSIA. You should follow the dosing schedule as prescribed by your doctor. You will need frequent medical tests, and your risk of infection could last for 3 months after you stop taking this medicine. Zeposia (ozanimod)." Ozanimod can cause a serious heart problem. -Days 5 through 7: 0.46 mg orally once daily Other side effects are usually rare but are very serious and require immediate medical help. Ozanimod is also used to treat adults with moderately to severely active ulcerative colitis. You are about to leave this website for another external website. The common, manageable side-effects of taking Zeposia include: Upper respiratory infection (bronchitis, laryngitis, pharyngitis, and other infections of upper airways). Call your doctor if you have a fever, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light. This is more common when you first start taking ozanimod. Your MS symptoms may return and become worse than before or during treatment with this medicine. Before you take ozanimod, tell your doctor if you have never had chickenpox or received a varicella vaccine (Varivax). 12 Medicines That Could Help. You should not receive a live vaccine within 1 month before taking ozanimod, while taking it, and for at least 3 months after you stop taking it. 2084-US-220076506/22, You are now leaving this Bristol Myers Squibbsite. These are some of the side effects reported by people taking ZEPOSIA during both of the clinicalstudies. Patients who move from commercial plans to state or federal healthcare programs will no longer be eligible, Patients pay as little as $0 in out-of-pocket costs per prescription, subject to a maximum benefit of $18,000 during a calendar year. UC trials ( 4%): Liver enzyme elevations, upper respiratory infection, headache. We comply with the HONcode standard for trustworthy health information. Data sources include IBM Watson Micromedex (updated 2 Dec 2022), Cerner Multum (updated 7 Dec 2022), ASHP (updated 11 Nov 2022) and others. Before taking ZEPOSIA, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Call your doctor if you have a fever, chills, aches, tiredness, cough, rash, painful and frequent urination, confusion, neck stiffness, or increased sensitivity to light. Some heart rhythm medications can cause unwanted or dangerous effects when used with ozanimod. Zeposia (ozanimod) is a disease-modifying treatment used for relapsing forms of MS. It is not known if ZEPOSIA is safe and effective in children. For people with UC, improvements in symptoms such as rectal bleeding and stool frequency were seen as early as week 2 and significant differences in clinical remission, clinical response, and endoscopicimprovement compared to placebo were noted within 10 weeks of starting ozanimod. You should not receive live vaccines during treatment with ZEPOSIA, for at least 1 month before taking ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Ozanimod is a not a biologic it is a small-molecule S1P receptor modulator that binds specifically to two S1P receptors and is thought to block the ability of lymphocytes to escape out of the lymph nodes reducing their numbers in the blood, gut, CNS, and inflamed tissue. MS Treatment Chart: Comparing Disease-Modifying Therapies. This list is not complete and many other drugs may interact with ozanimod. Drug information provided by: IBM Micromedex. Although not all of these side effects may occur, if they do occur they may need medical attention. What should I know regarding pregnancy, nursing and administering Ozanimod Oral to children or the elderly? Common side effects may include: back pain; urination problems; high or low blood pressure; abnormal liver function tests; or. The Program includes a prescription benefit offer for out-of-pocket drug costs and a medical assessment benefit offer for out-of-pocket costs for the initial blood tests, ECG screening, and eye exam, where the full cost is not covered by patient's insurance, Patients are not eligible for the prescription benefit offer if they have prescription insurance coverage through a state or federal healthcare program, including but not limited to Medicare, Medicaid, MediGap, CHAMPUS, TRICARE, Veterans Affairs (VA), or Department of Defense (DoD) programs. You may get infections more easily, even serious or fatal infections. Using ZEPOSIA with other medicines can cause serious side effects. Many of these side effects can be managed, and some may go away on their own over time. If you notice any other effects, check with your healthcare professional. Medically reviewed by Judith Stewart, BPharm. Learn more about its uses, indications, and side effects. Patients are responsible for any costs that exceed the maximum amounts, To receive the medical assessment benefit, an Explanation of Benefits (EOB) form must be submitted, along with copies of receipts for any payments made. Tell your doctor about all your other medicines, especially: alemtuzumab, clopidogrel, eltrombopag, gemfibrozil, rifampin; drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection; medicine to treat Parkinson's disease; or. discontinue ozanimod. ZEPOSIA may cause serious side effects, including: Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with ZEPOSIA and for 3months after your last dose of ZEPOSIA: Your healthcare provider may delay starting or may stop your ZEPOSIA treatment if you have an infection. Wait at least 14 days after stopping an MAO inhibitor before you take this medicine. Absorption. Things to remember when you fill your prescription. Side effects include: MS trials (4%): Upper respiratory infection, liver enzyme elevations, orthostatic hypotension, urinary tract infection, back pain, hypertension. Your doctor will test you for this genotype. Zeposia may cause side effects such as breathing problems, headache, back pain, and increased levels of liver enzymes. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use ozanimod only for the indication prescribed. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Headache. 2022 Bristol-Myers Squibb Company. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including: weakness on one (1) side of your body, changes in your vision, changes in your thinking or memory, confusion, changes in your personality, loss of coordination in your arms or legs, decreased strength, and/or problems with balance. It requires a 7 day titration period and reduces lymphocyte counts to within 45% of baseline values. INDICATIONS. An overdose of this drug likely results in adverse effects such as somnolence, fatigue, headache, dizziness, bradyarrhythmia, cardiac . Is ozanimod a biologic? Celgene Corporation (2020): Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. When starting a treatment, its important to understand what side effects are possible. Last updated on Nov 22, 2022. Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Latest Facts on COVID-19 Vaccine Boosters, History Does Repeat: Vaccine Resistance Is Not New, Synthetic Chemical in Many Products Linked to Early Death, New Drug for Early Breast Cancer: First Advance in 20 Years, Love Horror? Mayo Clinic does not endorse companies or products. ZEPOSIA (ozanimod) is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults. Last updated on Aug 19, 2022. Store at room temperature away from moisture and heat. Tell your doctor if you have a fever or infection, or if you have ever had: a weak immune system (caused by disease or by using certain medicine); ozanimod may harm an unborn baby. ZEPOSIA can cause serious side effects, including: The most common side effects of ZEPOSIA can include: These are not all of the possible side effects of ZEPOSIA. Humira, Stelara, Colazal, Pentasa, Dipentum, Azulfidine, Asacol, Rowasa, Lialda, Apriso. All rights reserved. Exercise caution if initiating treatment with other agents 4 weeks after the last dose of ozanimod. You may take ozanimod with or without food. The following side effects have been reported by at least 1% of people taking this medication. Follow all directions on your prescription label and read all medication guides or instruction sheets. You may report them to the FDA. . Call your doctor for medical advice about side effects. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. These side effects usually go away on their own and do not require any medical attention. Wait at least 14 days after stopping an MAO inhibitor before you take ozanimod. For at least 4 weeks after your last dose, tell any doctor who treats you that you have used this medicine. Too much bilirubin in the blood. Your healthcare provider may do a blood test for the chickenpox virus. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Patients pay as little as $0 in out-of-pocket costs for the medical assessment, subject to a maximum benefit of $2000. You may need to use a starter pack again, to gradually increase your dose. Your risk of infection could last for 3 months after you stop taking this medicine. Avoid getting a vaccine without first asking your doctor. blood in the urine or stools. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education, dizziness, faintness, or lightheadedness when getting up from lying or sitting position, Painful blisters on the trunk of the body, painful cold sores or blisters on the lips, nose, eyes, or genitals, swelling of the eyelids, face, lips, hands, or feet. Ozanimod is an S1P receptor modulator that may be used to treat relapsing forms of multiple sclerosis or ulcerative colitis in adults. Bottom Line. Do not use ozanimod if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. There were no serious infectious or cardiac adverse effects, and no cases of macular edema with ozanimod. You may report side effects to FDA at 1-800-FDA-1088. All drugs may cause side effects. Drug class: Selective immunosuppressants. The rest left the studies for a variety of other reasons. Call your healthcare provider if you experience the following symptoms of slow heart rate: Follow directions from your healthcare provider when starting ZEPOSIA and when you miss a dose. 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