ozanimod side effects

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. Your doctor may occasionally change your dose. For Healthcare Professionals Applies to ozanimod: oral capsule. 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. Data sources include IBM Watson Micromedex (updated 2 Dec 2022), Cerner Multum (updated 7 Dec 2022), ASHP (updated 11 Nov 2022) and others. Headache. 90% of people taking ZEPOSIA remained on treatment throughout the clinical studies. . 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. MAINTENANCE DOSE: 0.92 mg orally once daily starting on Day 8 If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ozanimod on the baby. Such therapies often prove insufficient alone and highlight the need for more targeted MS treatments with reduced systemic side effect profiles. Last updated on Nov 22, 2022. Other side effects are usually rare but are very serious and require immediate medical help. Not all possible drug interactions are listed here. Gamma-glutamyl transferase increased, and. Tell your doctor if you have received any vaccine within the past 30 days, or if you are scheduled to receive a vaccine. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Some side effects may not be reported. Zeposia (ozanimod) was approved for the treatment of adults with RRMS by: Which is the best infusion medicine for MS? chest pain. Selected from data included with permission and copyrighted by First Databank, Inc. Your doctor will test you for this genotype. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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, These include: When the relapse is over, the symptoms may disappear completely, but some problems may also remain. Toxicity. Upper respiratory tract infections and elevations in liver . The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. Medically reviewed by Philip Thornton, DipPharm. 1998-2022 Mayo Foundation for Medical Education and Research (MFMER). 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 pregnancy and breastfeeding warnings. ZEPOSIAa once-daily pill approved to treat adults with: Moderate to severe ulcerative colitis (UC), ZEPOSIA (ozanimod) Co-Pay Program Terms and Conditions. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. For more information, ask your healthcare provider orpharmacist. This is not a complete list of side effects and others may occur. Serious Interactions. Use effective birth control while using ozanimod and for at least 3 months after your last dose. 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. This website is intended for U.S. residents 18 years of age orolder. 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 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. 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. Brand name: Zeposia Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting. in a phase 3 trial of moderate to severe CD patients who experienced failure or unacceptable side effects with conventional therapies. The rest left the studies for a variety of other reasons. 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. Call your doctor for medical advice about side effects. 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. You should follow the dosing schedule as prescribed by your doctor. 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. Copyright 1996-2022 Cerner Multum, Inc. What are the side effects of Zeposia (Ozanimod)? All drugs may cause side effects. 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 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. ZEPOSIA (ozanimod) is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults. You are about to leave this website for another external website. Does Ozanimod Oral interact with other medications? Select a condition to view a list of medication options. However, many people have no side effects or only have minor side effects. You may report them to the FDA. 2084-US-220076506/22, You are now leaving this Bristol Myers Squibbsite. Things to remember when you fill your prescription. 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 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. Some heart rhythm medications can cause unwanted or dangerous effects when used with ozanimod. Monitor for respiratory effects (reductions in forced expiratory volume [FEV 1 ] and forced vital . [5] View complete list of side effects. 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 reduces how responsive the cardiac cells are and reduces their firing rate, which slows down the heart. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. 11 Its delayed absorption reduces effects that may occur after the first dose, such as heart rate changes. 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? Data sources include IBM Watson Micromedex (updated 2 Dec 2022), Cerner Multum (updated 7 Dec 2022), ASHP (updated 11 Nov 2022) and others. Why does ozanimod slow down your heart rate? You may get infections more easily, even serious or fatal infections. A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants . discontinue ozanimod. ZEPOSIA can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. Call your doctor for instructions. "Product Information. MS trials (4%): Upper respiratory infection, liver enzyme elevations, orthostatic hypotension, urinary tract infection, back pain, hypertension. 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 Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. . High levels of liver transaminase enzymes. Your risk of infection could last for 3 months after you stop taking ozanimod. 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. Drug information provided by: IBM Micromedex. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Ozanimod, sold under the brand name Zeposia, is an immunomodulatory medication for the treatment of relapsing multiple sclerosis and ulcerative colitis. 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. During clinical studies, people who took ZEPOSIA and those who took a leading injectable medicine were asked to report side effects that they experienced. Avoid getting a vaccine without first asking your doctor. Continue reading for additional possible serious side effects of ZEPOSIA. 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]. Your healthcare provider may do a blood test for the chickenpox virus. 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. Wait at least 14 days after stopping an MAO inhibitor before you take ozanimod. 12 Medicines That Could Help. Is ozanimod a biologic? Last updated on Aug 19, 2022. Certain foods that contain very high amounts (more than 150 mg) of tyramine could cause high blood pressure while you're taking Zeposia (ozanimod). In relapsing multiple sclerosis, the attacks on the nerve cells are followed by periods of recovery. 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. 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. You may get infections more easily, even serious or fatal infections. blood in the urine or stools. 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. It is not known if ZEPOSIA is safe and effective in children. DOSE TITRATION REGIMEN: If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Please see the full Prescribing Information and This may lower the risk of side effects. What are the new drugs used for multiple sclerosis (MS)? Uses: difficulty in breathing or swallowing. Call your doctor for medical advice about side effects. Applies to ozanimod: oral capsules. We comply with the HONcode standard for trustworthy health information. You may take ozanimod with or without food. -Day 8 and thereafter: 0.92 mg orally once a day What are the new drugs used for multiple sclerosis (MS). Side effects include: MS trials (4%): Upper respiratory infection, liver enzyme elevations, orthostatic hypotension, urinary tract infection, back pain, hypertension. This content does not have an English version. It is not known if ZEPOSIA passes into your breast milk. Tell your doctor right away if you develop any signs of an infection such as sore throat / cough. You may report side effects to FDA at 1-800-FDA-1088 1-800-FDA-1088. Should I avoid certain foods while taking Ozanimod Oral? Your doctor may change your treatment plan if you also use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol. 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. Using ZEPOSIA with other medicines can cause serious side effects. 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. 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. 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. . Before your first dose, your heart function will be checked using an electrocardiograph or ECG (sometimes called an EKG). All rights reserved. Avoid foods high in tyramine (aged, fermented, cured, smoked and pickled foods). Is ozanimod a biologic? for information on all of the side effects reported by those taking ZEPOSIA. If you feel you are experiencing aside effect while taking ZEPOSIA,reach out to your healthcareprofessional. All rights reserved. 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. Along with its needed effects, a medicine may cause some unwanted effects. Copyright 2022 IBM Watson Health. Download these 7 questions or send them to yourself for your nextappointment. 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 . WebMD does not provide medical advice, diagnosis or treatment. Take ozanimod exactly as prescribed by your doctor. You may need to receive the vaccine and then wait 1 month before taking this medicine. All rights reserved. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Specific Populations 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Portions of this document last updated: Dec. 01, 2022. What should I know regarding pregnancy, nursing and administering Ozanimod Oral to children or the elderly? Of those who stopped taking ZEPOSIA, 3% did so because of a side effect they experienced. 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. Davis Drug Guide PDF. For at least 4 weeks after your last dose, tell any doctor who treats you that you have used this medicine. Get emergency medical help if you have signs of an allergic reaction: hives, rash; difficult breathing; swelling of your face, lips, tongue,. Drug class: Selective immunosuppressants. This is more common when you first start taking ozanimod. You will need frequent medical tests, and your risk of infection could last for 3 months after you stop taking this medicine. Bottom Line. You also should not use ozanimod if you have severe untreated sleep apnea. Use of drugs with prolonged immune effects during this period can cause additive immunosuppressive effects and increase the risk of infection. Ozanimod can have long lasting effects on your body, especially on your immune system. The most common side effects of ZEPOSIA can include: upper respiratory tract infections low blood pressure when you stand up ( orthostatic hypotension) back pain Medically reviewed by Judith Stewart, BPharm. [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. Call your healthcare provider for medical advice about side effects. ozanimod; procainamide; protein kinase inhibitors (e.g., ceritinib, crizotinib, imatinib, lapatinib, pazopanib, sunitinib) quinidine; quinine; If you miss a dose after the first 2 weeks: Skip the missed dose and use your next dose at the regular time. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Zeposia (ozanimod) is a disease-modifying treatment used for relapsing forms of MS. MS Treatment Chart: Comparing Disease-Modifying Therapies. This list is not complete and many other drugs may interact with ozanimod. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Ulcerative Colitis (UC): ZEPOSIA is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults. Tell your doctor if you become pregnant. 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. Any links to other sites are provided merely as a convenience to users of this website. 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 . Pregnancy 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. UC trials ( 4%): Liver enzyme elevations, upper respiratory infection, headache. If you get an infection, further doses may be delayed until your infection clears up. 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 Arabic version. This site complies with the HONcode standard for trustworthy health information: verify here. 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. Before you take ozanimod, tell your doctor if you have never had chickenpox or received a varicella vaccine (Varivax). Medically reviewed by Alan Carter, Pharm.D. Why does ozanimod slow down your heart rate. Some heart rhythm medications can cause unwanted or dangerous effects when used with ozanimod. What conditions does Ozanimod Oral treat? 1. Ozanimod can slow your heart rate when you start taking it. Your risk of infection could last for 3 months after you stop taking this medicine. symptoms of infection -- fever, tiredness, cough, rash, increased urination, pain or burning when you urinate, neck stiffness, increased sensitivity to light. Ozanimod can cause a serious heart problem. Ozanimod is absorbed in the gastrointestinal tract after oral administration. When starting a treatment, its important to understand what side effects are possible. Although not all of these side effects may occur, if they do occur they may need medical attention. Dosage form: oral capsule (0.23 mg-0.46 mg; 0.23 mg-0.46 mg-0.92 mg; 0.92 mg) 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 Always ask your doctor before you stop taking ozanimod for any reason. 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. Ozanimod is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). Medication Guide you should know that ozanimod may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. INDICATIONS. Ask a doctor if it is safe to breastfeed while using this medicine. 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. Serious side effects of Inotuzumab include: Black, tarry stools. 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. 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. Ozanimod Dosage Medically reviewed by Drugs.com. If you experience any side effects while taking ZEPOSIA, be sure to talk to your doctor right away. It is not known if this medicine is safe and effective in children. Ozanimod is used only if you have a specific genotype. 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. 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. Absorption. These medications may interact and cause very harmful effects. You may report side effects to the FDA at 1-800-FDA-1088. All other trademarks are the property of their respective owner. severe untreated sleep apnea (breathing stops during sleep). These side effects usually go away on their own and do not require any medical attention. Advertising revenue supports our not-for-profit mission. Exercise caution if initiating treatment with other agents 4 weeks after the last dose of ozanimod. Store at room temperature away from moisture and heat. ZEPOSIA, ZEPOSIA 360 Support, and ZEPOSIA logo are trademarks of Celgene Corporation, a Bristol Myers Squibb company. Many of these side effects can be managed, and some may go away on their own over time. 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. -Days 1 through 4: 0.23 mg orally once a day -For the treatment of moderately to severely active ulcerative colitis. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. It requires a 7 day titration period and reduces lymphocyte counts to within 45% of baseline values. There were no serious infectious or cardiac adverse effects, and no cases of macular edema with ozanimod. ZEPOSIA may harm your unborn baby. Orthostatic hypotension (decreases in blood pressure when standing up or sitting down) Urinary tract infection. The Side-by-Side format only applies to the Protocol section of the study. 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. 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. Last updated on Nov 13, 2022. ZEPOSIA was approved for multiple sclerosis (MS) by the Food and Drug Administration (FDA) on 03/25/2020. Tell your doctor if you have slow heartbeats, chest pain, shortness of breath, feeling like your heart is skipping beats. Minor/Significance Unknown. This website is best viewed using the vertical display on your mobile device. Ozanimod is also used to treat adults with moderately to severely active ulcerative colitis. If you stop taking ozanimod or miss a dose during the first 2 weeks, ask your doctor before you start taking the medicine again. The following side effects have been reported by at least 1% of people taking this medication. Wait at least 14 days after stopping an MAO inhibitor before you take this medicine. 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. Vaccines may not work as well when given during treatment withZEPOSIA. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 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. 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. Your MS symptoms may return and become worse than before or during treatment with this medicine. Ozanimod is a novel, oral, small-molecule S1P 1 and . You may report side effects to FDA at 1-800-FDA-1088. Back pain. Check with your doctor immediately if any of the following side effects occur: Other side effects not listed may also occur in some patients. 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. Zeposia may cause side effects such as breathing problems, headache, back pain, and increased levels of liver enzymes. Common side effects may include: back pain; urination problems; high or low blood pressure; abnormal liver function tests; or. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Available for Android and iOS devices. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. 2022 Bristol-Myers Squibb Company. Mayo Clinic does not endorse companies or products. These are not all of the possible side effects of ZEPOSIA. Humira, Stelara, Colazal, Pentasa, Dipentum, Azulfidine, Asacol, Rowasa, Lialda, Apriso. If you notice any other effects, check with your healthcare professional. UC trials ( 4%): Liver enzyme elevations, upper respiratory infection, headache. An overdose of this drug likely results in adverse effects such as somnolence, fatigue, headache, dizziness, bradyarrhythmia, cardiac . This is not a complete list of side effects and others may occur. BMS has no responsibility for the content of such other sites and is not liable for any damages or injury arising from that content. 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. symptoms of infection - fever, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light. Too much bilirubin in the blood. 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. The common, manageable side-effects of taking Zeposia include: Upper respiratory infection (bronchitis, laryngitis, pharyngitis, and other infections of upper airways). 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? Follow all directions on your prescription label and read all medication guides or instruction sheets. While you are taking ozanimod, a "live" vaccine may not fully protect you from disease and you could develop an infection. Eating these foods while taking this medicine can raise your blood pressure. 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. View chapter Purchase book Here are the side effects that occurred in at least 4% of people, along with the percentage of people who experiencedeach. 4. Ozanimod can slow your heart rate when you start taking it. Vaccines may not work as well when given during treatment withZEPOSIA. These could be symptoms of a serious liver problem. You may report side effects to FDA at 1-800-FDA-1088. You may be more likely to get a serious (possibly fatal) infection (such as bronchitis, herpes). 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. These are not all of the side effects that may occur. Ozanimod is an S1P receptor modulator that may be used to treat relapsing forms of multiple sclerosis or ulcerative colitis in adults. 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? 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. 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. Version: 4.02. 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. 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