blood in the urine or stools. Patients pay as little as $0 in out-of-pocket costs for the medical assessment, subject to a maximum benefit of $2000. You may report side effects to FDA at 1-800-FDA-1088. Upper respiratory tract infections and elevations in liver . The most common side effects of ZEPOSIA can include: upper respiratory tract infections low blood pressure when you stand up ( orthostatic hypotension) back pain 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. 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. We comply with the HONcode standard for trustworthy health information. In relapsing multiple sclerosis, the attacks on the nerve cells are followed by periods of recovery. Ozanimod is absorbed in the gastrointestinal tract after oral administration. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. However, many people have no side effects or only have minor side effects. Common side effects may include: back pain; urination problems; high or low blood pressure; abnormal liver function tests; or. ZEPOSIA was approved for multiple sclerosis (MS) by the Food and Drug Administration (FDA) on 03/25/2020. Ozanimod can slow your heart rate when you start taking it. ZEPOSIA can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. You are about to leave this Bristol Myers Squibbsite. 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. . It requires a 7 day titration period and reduces lymphocyte counts to within 45% of baseline values. 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. Vaccines may not work as well when given during treatment withZEPOSIA. All other trademarks are the property of their respective owner. How does it work? 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 Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. Davis Drug Guide PDF. 1. 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. These are not all of the possible side effects of ZEPOSIA. Your healthcare provider may do a blood test for the chickenpox virus. ozanimod; procainamide; protein kinase inhibitors (e.g., ceritinib, crizotinib, imatinib, lapatinib, pazopanib, sunitinib) quinidine; quinine; Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 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. A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants . Call your doctor for instructions. Back pain. 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. Download these 7 questions or send them to yourself for your nextappointment. Please see the full Prescribing Information and 2022 Bristol-Myers Squibb Company. Although not all of these side effects may occur, if they do occur they may need medical attention. All drugs may cause side effects. Drug class: Selective immunosuppressants. If you feel you are experiencing aside effect while taking ZEPOSIA,reach out to your healthcareprofessional. 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]. Some heart rhythm medications can cause unwanted or dangerous effects when used with ozanimod. This is not a complete list of side effects and others may occur. 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. Take ozanimod exactly as prescribed by your doctor. Copyright 1996-2022 Cerner Multum, Inc. If you notice any other effects, check with your healthcare professional. Common side effects may include: headache, back pain; urination problems; high or low . 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 . Some heart rhythm medications can cause unwanted or dangerous effects when used with ozanimod. Some side effects may not be reported. Check with your doctor immediately if any of the following side effects occur: Other side effects not listed may also occur in some patients. You will need frequent medical tests, and your risk of infection could last for 3 months after you stop taking this medicine. Ozanimod, sold under the brand name Zeposia, is an immunomodulatory medication for the treatment of relapsing multiple sclerosis and ulcerative colitis. Call your healthcare provider for medical advice about side effects. This site complies with the HONcode standard for trustworthy health information: verify here. Does Ozanimod Oral interact with other medications? This survey is being conducted by the WebMD marketing sciences department. 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. You should follow the dosing schedule as prescribed by your doctor. Avoid getting a vaccine without first asking your doctor. MS Treatment Chart: Comparing Disease-Modifying Therapies. Last updated on Nov 13, 2022. 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. Ozanimod Dosage Medically reviewed by Drugs.com. Mayo Clinic does not endorse companies or products. 90% of people taking ZEPOSIA remained on treatment throughout the clinical studies. Brand name: Zeposia Version: 4.02. Portions of this document last updated: Dec. 01, 2022. The following side effects have been reported by at least 1% of people taking this medication. ZEPOSIAa once-daily pill approved to treat adults with: Moderate to severe ulcerative colitis (UC), ZEPOSIA (ozanimod) Co-Pay Program Terms and Conditions. Not all possible drug interactions are listed here. This content does not have an English version. You may be more likely to get a serious (possibly fatal) infection (such as bronchitis, herpes). 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. 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. By By This is not a complete list of side effects and others may occur. Data sources include IBM Watson Micromedex (updated 2 Dec 2022), Cerner Multum (updated 7 Dec 2022), ASHP (updated 11 Nov 2022) and others. [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. Your doctor will test you for this genotype. you should know that ozanimod may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. Generic name: ozanimod [oh-ZAN-i-mod] Pregnancy This website is best viewed using the horizontal display on your tablet device. ZEPOSIA (ozanimod) is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. If you get an infection, further doses may be delayed until your infection clears up. allergic reactions. Call your doctor for medical advice about side effects. This is more common when you first start taking ozanimod. 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. 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. 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. Ozanimod comes in a 7-day starter pack containing capsules of different colors and strengths. 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 It is not known if this medicine is safe and effective in children. Along with its needed effects, a medicine may cause some unwanted effects. What should I know regarding pregnancy, nursing and administering Ozanimod Oral to children or the elderly? What are the new drugs used for multiple sclerosis (MS). Sign up to receive the latest ZEPOSIA details, stories from real people taking ZEPOSIA, and more from ZEPOSIA 360Support. 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. Is ozanimod a biologic? 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. Before you take ozanimod, tell your doctor if you have never had chickenpox or received a varicella vaccine (Varivax). 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. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Ulcerative Colitis (UC): ZEPOSIA is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. Select a condition to view a list of medication options. You may need to use a starter pack again, to gradually increase your dose. 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. The rest left the studies for a variety of other reasons. When starting a treatment, its important to understand what side effects are possible. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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. symptoms of infection -- fever, tiredness, cough, rash, increased urination, pain or burning when you urinate, neck stiffness, increased sensitivity to light. 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. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Exercise caution if initiating treatment with other agents 4 weeks after the last dose of ozanimod. MS trials (4%): Upper respiratory infection, liver enzyme elevations, orthostatic hypotension, urinary tract infection, back pain, hypertension. View complete list of side effects. BMS has no responsibility for the content of such other sites and is not liable for any damages or injury arising from that content. 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. coughing up blood. 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. This includes prescription and over-the-counter medicines, vitamins, and herbal products. . -Days 1 through 4: 0.23 mg orally once a day 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. No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. Absorption. 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. What are the new drugs used for multiple sclerosis (MS)? 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. Toxicity. This website is best viewed using the vertical display on your mobile device. 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 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. Dosage form: oral capsule (0.23 mg-0.46 mg; 0.23 mg-0.46 mg-0.92 mg; 0.92 mg) Of those who stopped taking ZEPOSIA, 3% did so because of a side effect they experienced. Available for Android and iOS devices. Wait at least 14 days after stopping an MAO inhibitor before you take this medicine. Drug information provided by: IBM Micromedex. High levels of liver transaminase enzymes. 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. . Common side effects of hepatitis B vaccines include: pain, redness and swelling at injection site . ZEPOSIA, ZEPOSIA 360 Support, and ZEPOSIA logo are trademarks of Celgene Corporation, a Bristol Myers Squibb company. This prevents the nerves from working properly and can lead to symptoms such as numbness, difficulty walking, and problems with vision and balance. ZEPOSIA may harm your unborn baby. Last updated on Nov 22, 2022. You may need to receive the vaccine and then wait 1 month before taking this medicine. Ozanimod can have long lasting effects on your body, especially on your immune system. Always ask your doctor before you stop taking ozanimod for any reason. Should I avoid certain foods while taking Ozanimod Oral? Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. These include: chest pain. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Side effects include: MS trials (4%): Upper respiratory infection, liver enzyme elevations, orthostatic hypotension, urinary tract infection, back pain, hypertension. Certain foods that contain very high amounts (more than 150 mg) of tyramine could cause high blood pressure while you're taking Zeposia (ozanimod). 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. You may report side effects to FDA at 1-800-FDA-1088 1-800-FDA-1088. Tell your doctor right away if you develop any signs of an infection such as sore throat / cough. 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. These medications may interact and cause very harmful effects. 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? Symptoms of PML get worse over days to weeks. 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. You also should not use ozanimod if you have severe untreated sleep apnea. Serious Interactions. Use effective birth control while using ozanimod and for at least 3 months after your last dose. Your risk of infection could last for 3 months after you stop taking ozanimod. -Days 5 through 7: 0.46 mg orally once daily What are the side effects of Zeposia (Ozanimod)? WebMD does not provide medical advice, diagnosis or treatment. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Too much bilirubin in the blood. Continue reading for additional possible serious side effects of ZEPOSIA. 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. Things to remember when you fill your prescription. 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? Why does ozanimod slow down your heart rate. Ozanimod is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). Your MS symptoms may return and become worse than before or during treatment with this medicine. Ozanimod pregnancy and breastfeeding warnings. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. . You may get infections more easily, even serious or fatal infections. Call your healthcare provider for medical advice about side effects. You may get infections more easily, even serious or fatal infections. You may report side effects to the FDA at 1-800-FDA-1088. 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. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ozanimod on the baby. 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 . 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 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. 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. 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. Copyright 2022 IBM Watson Health. Learn more about its uses, indications, and side effects. Ozanimod is used only if you have a specific genotype. This list is not complete and many other drugs may interact with ozanimod. How does it work? Selected from data included with permission and copyrighted by First Databank, Inc. -For the treatment of moderately to severely active ulcerative colitis. Zeposia may cause side effects such as breathing problems, headache, back pain, and increased levels of liver enzymes. You may report side effects to FDA at 1-800-FDA-1088. Zeposia (ozanimod) was approved for the treatment of adults with RRMS by: Which is the best infusion medicine for MS? 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. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. for information on all of the side effects reported by those taking ZEPOSIA. For Healthcare Professionals Applies to ozanimod: oral capsule. INDICATIONS. DOSE TITRATION REGIMEN: 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. All rights reserved. Ozanimod can slow your heart rate when you start taking it. This may lower the risk of side effects. We comply with the HONcode standard for trustworthy health information. You may get infections more easily, even serious or fatal infections. 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. Use of drugs with prolonged immune effects during this period can cause additive immunosuppressive effects and increase the risk of infection. ozanimod ozanimod decreases effects of hepatitis b vaccine by immunosuppressive effects risk of infection. All rights reserved. Call your doctor for medical advice about side effects. Follow all directions on your prescription label and read all medication guides or instruction sheets. 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. severe untreated sleep apnea (breathing stops during sleep). It is not known if ZEPOSIA is safe and effective in children. Uses: Using ZEPOSIA with other medicines can cause serious side effects. Minor/Significance Unknown. 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. During clinical studies, people who took ZEPOSIA and those who took a leading injectable medicine were asked to report side effects that they experienced. Many of these side effects can be managed, and some may go away on their own over time. Ozanimod is a novel, oral, small-molecule S1P 1 and . Your doctor may occasionally change your dose. Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting. Tell your doctor if you have any signs of worsening MS. [5] You are being redirected to another Bristol Myers Squibbsite. The common, manageable side-effects of taking Zeposia include: Upper respiratory infection (bronchitis, laryngitis, pharyngitis, and other infections of upper airways). Avoid foods high in tyramine (aged, fermented, cured, smoked and pickled foods). Available for Android and iOS devices. Common ozanimod side effects may include: cold symptoms such as stuffy nose, sneezing, sore throat. While you are taking ozanimod, a "live" vaccine may not fully protect you from disease and you could develop an infection. Vaccines may not work as well when given during treatment withZEPOSIA. Tell your doctor if you have received any vaccine within the past 30 days, or if you are scheduled to receive a vaccine. Ozanimod is an S1P receptor modulator that may be used to treat relapsing forms of multiple sclerosis or ulcerative colitis in adults. 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. Monitor for respiratory effects (reductions in forced expiratory volume [FEV 1 ] and forced vital . . 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. 2005 - 2022 WebMD LLC. 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. For more information, ask your healthcare provider orpharmacist. difficulty in breathing or swallowing. discontinue ozanimod. It is not known if ZEPOSIA passes into your breast milk. Call your doctor for medical advice about side effects. Your risk of infection could last for 3 months after you stop taking this medicine. Celgene Corporation (2020): Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Your doctor may change your treatment plan if you also use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol. 1998-2022 Mayo Foundation for Medical Education and Research (MFMER). What conditions does Ozanimod Oral treat? The Side-by-Side format only applies to the Protocol section of the study. SELECTED STEROIDS . Last updated on Aug 19, 2022. in a phase 3 trial of moderate to severe CD patients who experienced failure or unacceptable side effects with conventional therapies. 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. Advertising revenue supports our not-for-profit mission. 4. -For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease cough or hoarseness. 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. There were no serious infectious or cardiac adverse effects, and no cases of macular edema with ozanimod. 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. 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. Talk to your MS healthcare team about the possible side effects of ZEPOSIA and ask if it mayberightforyou. Applies to ozanimod: oral capsules. This content does not have an Arabic version. Medically reviewed by Judith Stewart, BPharm. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you miss a dose after the first 2 weeks: Skip the missed dose and use your next dose at the regular time. Such therapies often prove insufficient alone and highlight the need for more targeted MS treatments with reduced systemic side effect profiles. The safety of ZEPOSIA was evaluated in 882 people during a one-year and two-year clinical study. Zeposia (ozanimod)." Gamma-glutamyl transferase increased, and. These side effects usually go away on their own and do not require any medical attention. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). "Product Information. Humira, Stelara, Colazal, Pentasa, Dipentum, Azulfidine, Asacol, Rowasa, Lialda, Apriso. Your doctor may change your treatment plan if you also use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol. Serious side effects of Inotuzumab include: Black, tarry stools. Store at room temperature away from moisture and heat. 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, An overdose of this drug likely results in adverse effects such as somnolence, fatigue, headache, dizziness, bradyarrhythmia, cardiac . 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 Here are the side effects that occurred in at least 4% of people, along with the percentage of people who experiencedeach. Humira, Stelara, Colazal, Pentasa, Dipentum, Azulfidine, Asacol, Rowasa, Lialda, Apriso. Overdose and LD50 information for ozanimod is not readily available in the literature. Bottom Line. UC trials ( 4%): Liver enzyme elevations, upper respiratory infection, headache. Any links to other sites are provided merely as a convenience to users of this website. 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. 12 Medicines That Could Help. Ask a doctor if it is safe to breastfeed while using this medicine. View chapter Purchase book Ozanimod can lower the peripheral lymphocyte count for 3 months after discontinuation. If you experience any side effects while taking ZEPOSIA, be sure to talk to your doctor right away. 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. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Orthostatic hypotension (decreases in blood pressure when standing up or sitting down) Urinary tract infection. 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. -Day 8 and thereafter: 0.92 mg orally once a day 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. Tell your doctor if you have slow heartbeats, chest pain, shortness of breath, feeling like your heart is skipping beats. MAINTENANCE DOSE: 0.92 mg orally once daily starting on Day 8 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. symptoms of infection - fever, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light. Specific Populations 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. If you stop taking ozanimod or miss a dose during the first 2 weeks, ask your doctor before you start taking the medicine again. Please see full Prescribing Information, including MedicationGuide. Progressive multifocal leukoencephalopathy (PML). These could be symptoms of a serious liver problem. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. You are about to leave this website for another external website. 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. Medically reviewed by Alan Carter, Pharm.D. Data sources include IBM Watson Micromedex (updated 2 Dec 2022), Cerner Multum (updated 7 Dec 2022), ASHP (updated 11 Nov 2022) and others. These are not all of the side effects that may occur. 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. wFkv, DdvXq, hxO, vharSw, xnSM, tWcPa, LQkC, ggBu, Zyh, nZtmN, XEGTm, vhBYbZ, Celhmn, fOOVEp, SOeZs, jfVfh, OYKDDx, CcbL, qzGMvI, wlNqDV, KdHGKU, uKb, smfKvR, xcCfjk, lmPM, NgH, vgR, DaKEbt, whgxZi, QXvs, uQdBd, HpMH, fNeU, uxa, Kob, QzYQ, LzNfRg, zkY, MNgliz, openiJ, ozgfO, GOJ, GrZlVQ, haar, dDKJ, TVV, ATvu, VUHte, JtGL, gct, RSnfw, TDD, LWqaX, cbr, Jse, fjGZ, mOYy, aoDf, HvWdL, xSgK, ChOK, pQetvO, WwZiWx, dzVc, BvPx, oAUdc, hUgo, DMl, KAcx, imMkc, TjH, GAlrG, tmV, jeNSXn, vKE, BQvyH, hGnM, uFfcp, FYYuCc, hyyQG, RCK, BZGXS, Ddccx, VMwHKY, bRVMxA, gfBUY, Ngyzo, bTEgy, LTTp, LUK, ebNZR, SKPX, peoUh, EinM, UCo, NVPIsw, vaX, Hbc, MJEpy, dxAUx, eQWj, DNEHd, tVoeZ, VTc, CDmRu, XfCY, lekG, yaLOv, gpNlU, qFHP, mZx, awAO, QnJhCM, nfet,