Drug information provided by: IBM Micromedex. 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. For Healthcare Professionals Applies to ozanimod: oral capsule. 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. discontinue ozanimod. Wait at least 14 days after stopping an MAO inhibitor before you take this medicine. blood in the urine or stools. Use of drugs with prolonged immune effects during this period can cause additive immunosuppressive effects and increase the risk of infection. Ask a doctor if it is safe to breastfeed while using this medicine. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. You may report them to the FDA. These side effects usually go away on their own and do not require any medical attention. Overdose and LD50 information for ozanimod is not readily available in the literature. Using ZEPOSIA with other medicines can cause serious side effects. You are about to leave this website for another external website. WebMD does not provide medical advice, diagnosis or treatment. Last updated on Nov 13, 2022. This website is best viewed using the vertical display on your mobile device. Continue reading. Zeposia (ozanimod) was approved for the treatment of adults with RRMS by: Which is the best infusion medicine for MS? This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. We comply with the HONcode standard for trustworthy health information. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). ZEPOSIA (ozanimod) is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults. Always ask your doctor before you stop taking ozanimod for any reason. Certain foods that contain very high amounts (more than 150 mg) of tyramine could cause high blood pressure while you're taking Zeposia (ozanimod). Uses: What are the side effects of Zeposia (Ozanimod)? Exercise caution if initiating treatment with other agents 4 weeks after the last dose of ozanimod. Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting. SELECTED STEROIDS . This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Copyright 1996-2022 Cerner Multum, Inc. 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. Sign up to receive the latest ZEPOSIA details, stories from real people taking ZEPOSIA, and more from ZEPOSIA 360Support. -Days 1 through 4: 0.23 mg orally once a day We comply with the HONcode standard for trustworthy health information. MS Treatment Chart: Comparing Disease-Modifying Therapies. There were no serious infectious or cardiac adverse effects, and no cases of macular edema with ozanimod. What are the new drugs used for multiple sclerosis (MS). Copyright 2022 IBM Watson Health. Other side effects are usually rare but are very serious and require immediate medical help. Upper respiratory tract infections and elevations in liver . These medications may interact and cause very harmful effects. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Ozanimod comes in a 7-day starter pack containing capsules of different colors and strengths. If you stop taking ozanimod or miss a dose during the first 2 weeks, ask your doctor before you start taking the medicine again. . Ozanimod is a novel, oral, small-molecule S1P 1 and . This is not a complete list of side effects and others may occur. symptoms of infection -- fever, tiredness, cough, rash, increased urination, pain or burning when you urinate, neck stiffness, increased sensitivity to light. Medically reviewed by Philip Thornton, DipPharm. It is not known if ZEPOSIA is safe and effective in children. 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 includes prescription and over-the-counter medicines, vitamins, and herbal products. This may lower the risk of side effects. How does it work? Why does ozanimod slow down your heart rate? 4. Monitor for respiratory effects (reductions in forced expiratory volume [FEV 1 ] and forced vital . Celgene Corporation (2020): Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Ozanimod can lower the peripheral lymphocyte count for 3 months after discontinuation. The rest left the studies for a variety of other reasons. These are not all of the side effects that may occur. Mayo Clinic does not endorse companies or products. UC trials ( 4%): Liver enzyme elevations, upper respiratory infection, headache. 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. If you experience any side effects while taking ZEPOSIA, be sure to talk to your doctor right away. 2005 - 2022 WebMD LLC. View chapter Purchase book Zeposia may cause side effects such as breathing problems, headache, back pain, and increased levels of liver enzymes. 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. Ozanimod is also used to treat adults with moderately to severely active ulcerative colitis. difficulty in breathing or swallowing. Ozanimod is used only if you have a specific genotype. Talk to your MS healthcare team about the possible side effects of ZEPOSIA and ask if it mayberightforyou. By By -For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease 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. symptoms of infection - fever, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light. coughing up blood. Is ozanimod a biologic? Bottom Line. Last updated on Nov 22, 2022. Ozanimod can have long lasting effects on your body, especially on your immune system. Some heart rhythm medications can cause unwanted or dangerous effects when used with ozanimod. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. All rights reserved. These are some of the side effects reported by people taking ZEPOSIA during both of the clinicalstudies. 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 if you have slow heartbeats, chest pain, shortness of breath, feeling like your heart is skipping beats. During clinical studies, people who took ZEPOSIA and those who took a leading injectable medicine were asked to report side effects that they experienced. Things to remember when you fill your prescription. You also should not use ozanimod if you have severe untreated sleep apnea. You may report side effects to the FDA at 1-800-FDA-1088. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. 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. 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 This survey is being conducted by the WebMD marketing sciences department. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. All rights reserved. . This prevents the nerves from working properly and can lead to symptoms such as numbness, difficulty walking, and problems with vision and balance. ozanimod; procainamide; protein kinase inhibitors (e.g., ceritinib, crizotinib, imatinib, lapatinib, pazopanib, sunitinib) quinidine; quinine; Toxicity. What are the new drugs used for multiple sclerosis (MS)? 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. What conditions does Ozanimod Oral treat? Common side effects may include: back pain; urination problems; high or low blood pressure; abnormal liver function tests; or. 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 An overdose of this drug likely results in adverse effects such as somnolence, fatigue, headache, dizziness, bradyarrhythmia, cardiac . ZEPOSIAa once-daily pill approved to treat adults with: Moderate to severe ulcerative colitis (UC), ZEPOSIA (ozanimod) Co-Pay Program Terms and Conditions. For at least 4 weeks after your last dose, tell any doctor who treats you that you have used this medicine. 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. 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. Learn more about its uses, indications, and side effects. Your doctor will test you for this genotype. You may report side effects to FDA at 1-800-FDA-1088 1-800-FDA-1088. Along with its needed effects, a medicine may cause some unwanted effects. Medically reviewed by Judith Stewart, BPharm. Ozanimod Dosage Medically reviewed by Drugs.com. 1998-2022 Mayo Foundation for Medical Education and Research (MFMER). 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. Available for Android and iOS devices. Any links to other sites are provided merely as a convenience to users of this website. allergic reactions. Brand name: Zeposia 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. Gamma-glutamyl transferase increased, and. Call your doctor for medical advice about side effects. Available for Android and iOS devices. 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. 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. BMS has no responsibility for the content of such other sites and is not liable for any damages or injury arising from that content. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ozanimod on the baby. These include: This content does not have an English version. Serious Interactions. All drugs may cause side effects. Zeposia (ozanimod) is a disease-modifying treatment used for relapsing forms of MS. You may need to receive the vaccine and then wait 1 month before taking this medicine. Ozanimod is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). You should follow the dosing schedule 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. Your doctor may occasionally change your dose. 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. Orthostatic hypotension (decreases in blood pressure when standing up or sitting down) Urinary tract infection. 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. Call your doctor for medical advice about side effects. Side effects include: MS trials (4%): Upper respiratory infection, liver enzyme elevations, orthostatic hypotension, urinary tract infection, back pain, hypertension. 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. Humira, Stelara, Colazal, Pentasa, Dipentum, Azulfidine, Asacol, Rowasa, Lialda, Apriso. 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. 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. If you miss a dose after the first 2 weeks: Skip the missed dose and use your next dose at the regular time. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. 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. Follow all directions on your prescription label and read all medication guides or instruction sheets. You may get infections more easily, even serious or fatal infections. 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. A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants . Selected from data included with permission and copyrighted by First Databank, Inc. The safety of ZEPOSIA was evaluated in 882 people during a one-year and two-year clinical study. 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 . No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. [5] INDICATIONS. 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. Applies to ozanimod: oral capsules. Continue reading for additional possible serious side effects of ZEPOSIA. Ozanimod is an S1P receptor modulator that may be used to treat relapsing forms of multiple sclerosis or ulcerative colitis in adults. Vaccines may not work as well when given during treatment withZEPOSIA. Dosage form: oral capsule (0.23 mg-0.46 mg; 0.23 mg-0.46 mg-0.92 mg; 0.92 mg) Here are the side effects that occurred in at least 4% of people, along with the percentage of people who experiencedeach. . Your doctor may change your treatment plan if you also use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol. Your doctor may change your treatment plan if you also use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol. You are being redirected to another Bristol Myers Squibbsite. Take ozanimod exactly as prescribed by your doctor. Call your healthcare provider for medical advice about side effects. Before your first dose, your heart function will be checked using an electrocardiograph or ECG (sometimes called an EKG). you should know that ozanimod may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. 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. Absorption. 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. Why does ozanimod slow down your heart rate. Ozanimod pregnancy and breastfeeding warnings. 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. If you feel you are experiencing aside effect while taking ZEPOSIA,reach out to your healthcareprofessional. When the relapse is over, the symptoms may disappear completely, but some problems may also remain. "Product Information. Zeposia (ozanimod)." 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. However, many people have no side effects or only have minor side effects. The common, manageable side-effects of taking Zeposia include: Upper respiratory infection (bronchitis, laryngitis, pharyngitis, and other infections of upper airways). . It is not known if ZEPOSIA passes into your breast milk. Davis Drug Guide PDF. How does it work? ozanimod ozanimod decreases effects of hepatitis b vaccine by immunosuppressive effects risk of infection. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. MS trials (4%): Upper respiratory infection, liver enzyme elevations, orthostatic hypotension, urinary tract infection, back pain, hypertension. Eating these foods while taking this medicine can raise your blood pressure. UC trials ( 4%): Liver enzyme elevations, upper respiratory infection, headache. For more information, ask your healthcare provider orpharmacist. Ozanimod can slow your heart rate when you start taking it. ZEPOSIA, ZEPOSIA 360 Support, and ZEPOSIA logo are trademarks of Celgene Corporation, a Bristol Myers Squibb company. Back pain. 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. ZEPOSIA can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. Data sources include IBM Watson Micromedex (updated 2 Dec 2022), Cerner Multum (updated 7 Dec 2022), ASHP (updated 11 Nov 2022) and others. 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. Of those who stopped taking ZEPOSIA, 3% did so because of a side effect they experienced. 1. Last updated on Aug 19, 2022. Some heart rhythm medications can cause unwanted or dangerous effects when used with 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. Please see full Prescribing Information, including MedicationGuide. 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. DOSE TITRATION REGIMEN: This site complies with the HONcode standard for trustworthy health information: verify here. 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 Progressive multifocal leukoencephalopathy (PML). Generic name: ozanimod [oh-ZAN-i-mod] Pregnancy This website is best viewed using the horizontal display on your tablet device. Tell your doctor right away if you develop any signs of an infection such as sore throat / cough. 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. Should I avoid certain foods while taking Ozanimod Oral? 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. 90% of people taking ZEPOSIA remained on treatment throughout the clinical studies. Some side effects may not be reported. Common ozanimod side effects may include: cold symptoms such as stuffy nose, sneezing, sore throat. This is not a complete list of side effects and others may occur. 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. You may take ozanimod with or without food. 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. This reduces how responsive the cardiac cells are and reduces their firing rate, which slows down the heart. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. 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. 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? for information on all of the side effects reported by those taking ZEPOSIA. 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. -Days 5 through 7: 0.46 mg orally once daily Your risk of infection could last for 3 months after you stop taking ozanimod. ZEPOSIA may harm your unborn baby. 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, Is ozanimod a biologic? Avoid getting a vaccine without first asking your doctor. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Medically reviewed by Alan Carter, Pharm.D. 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. Ulcerative Colitis (UC): ZEPOSIA is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults. 2084-US-220076506/22, You are now leaving this Bristol Myers Squibbsite. Wait at least 14 days after stopping an MAO inhibitor before you take ozanimod. ZEPOSIA was approved for multiple sclerosis (MS) by the Food and Drug Administration (FDA) on 03/25/2020. Your healthcare provider may do a blood test for the chickenpox virus. 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. Many of these side effects can be managed, and some may go away on their own over time. Avoid foods high in tyramine (aged, fermented, cured, smoked and pickled foods). Call your healthcare provider for medical advice about side effects. 11 Its delayed absorption reduces effects that may occur after the first dose, such as heart rate changes. 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. Medication Guide You may get infections more easily, even serious or fatal infections. 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? It requires a 7 day titration period and reduces lymphocyte counts to within 45% of baseline values. Please see the full Prescribing Information and Not all possible drug interactions are listed here. Use effective birth control while using ozanimod and for at least 3 months after your last dose. 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. Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. Call your doctor for instructions. Drug class: Selective immunosuppressants. 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. Patients pay as little as $0 in out-of-pocket costs for the medical assessment, subject to a maximum benefit of $2000. View complete list of side effects. 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 . 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. Store at room temperature away from moisture and heat. If you get an infection, further doses may be delayed until your infection clears up. 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. Download these 7 questions or send them to yourself for your nextappointment. 2022 Bristol-Myers Squibb Company. These could be symptoms of a serious liver problem. Vaccines may not work as well when given during treatment withZEPOSIA. Common side effects of hepatitis B vaccines include: pain, redness and swelling at injection site . Advertising revenue supports our not-for-profit mission. 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? These are not all of the possible side effects of ZEPOSIA. Common side effects may include: headache, back pain; urination problems; high or low . The most common side effects of ZEPOSIA can include: upper respiratory tract infections low blood pressure when you stand up ( orthostatic hypotension) back pain 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. If you notice any other effects, check with your healthcare professional. 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. You will need frequent medical tests, and your risk of infection could last for 3 months after you stop taking this medicine. The following side effects have been reported by at least 1% of people taking this medication. Version: 4.02. Ozanimod can cause a serious heart problem. This content does not have an Arabic version. Does Ozanimod Oral interact with other medications? When starting a treatment, its important to understand what side effects are possible. You are about to leave this Bristol Myers Squibbsite. You may need to use a starter pack again, to gradually increase your dose. You may get infections more easily, even serious or fatal infections. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Symptoms of PML get worse over days to weeks. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. MAINTENANCE DOSE: 0.92 mg orally once daily starting on Day 8 Tell your doctor if you have any signs of worsening MS. While you are taking ozanimod, a "live" vaccine may not fully protect you from disease and you could develop an infection. The Side-by-Side format only applies to the Protocol section of the study. 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. in a phase 3 trial of moderate to severe CD patients who experienced failure or unacceptable side effects with conventional therapies. -Day 8 and thereafter: 0.92 mg orally once a day Ozanimod, sold under the brand name Zeposia, is an immunomodulatory medication for the treatment of relapsing multiple sclerosis and ulcerative colitis. This is more common when you first start taking ozanimod. Tell your doctor if you have received any vaccine within the past 30 days, or if you are scheduled to receive a vaccine. Call your doctor for medical advice about side effects. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. This website is intended for U.S. residents 18 years of age orolder. severe untreated sleep apnea (breathing stops during sleep). Portions of this document last updated: Dec. 01, 2022. Your risk of infection could last for 3 months after you stop taking this medicine. . This list is not complete and many other drugs may interact with ozanimod. Such therapies often prove insufficient alone and highlight the need for more targeted MS treatments with reduced systemic side effect profiles. Minor/Significance Unknown. chest pain. -For the treatment of moderately to severely active ulcerative colitis. [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. You may report side effects to FDA at 1-800-FDA-1088. What should I know regarding pregnancy, nursing and administering Ozanimod Oral to children or the elderly? Before you take ozanimod, tell your doctor if you have never had chickenpox or received a varicella vaccine (Varivax). Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 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. Specific Populations 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. Humira, Stelara, Colazal, Pentasa, Dipentum, Azulfidine, Asacol, Rowasa, Lialda, Apriso. 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. 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. Too much bilirubin in the blood. 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. 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. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Although not all of these side effects may occur, if they do occur they may need medical attention. In relapsing multiple sclerosis, the attacks on the nerve cells are followed by periods of recovery. 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. Check with your doctor immediately if any of the following side effects occur: Other side effects not listed may also occur in some patients. Ozanimod can slow your heart rate when you start taking it. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Tell your doctor if you become pregnant. 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). 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 Headache. 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. cough or hoarseness. Serious side effects of Inotuzumab include: Black, tarry stools. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Your MS symptoms may return and become worse than before or during treatment with this medicine. High levels of liver transaminase enzymes. 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. 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]. All rights reserved. Select a condition to view a list of medication options. 12 Medicines That Could Help. Data sources include IBM Watson Micromedex (updated 2 Dec 2022), Cerner Multum (updated 7 Dec 2022), ASHP (updated 11 Nov 2022) and others. It is not known if this medicine is safe and effective in children. 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. All other trademarks are the property of their respective owner. 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