Generic name: ozanimod [ oh-ZAN-i-mod ]
Dosage form: oral capsule (0.23 mg; 0.46 mg; 0.92 mg)
Drug class: Selective immunosuppressants

Medically reviewed by Melisa Puckey, BPharm. Last updated on Sep 6, 2024.

What is Zeposia?

Zeposia (ozanimod) capsules are used to treat adults with types relapsing forms of multiple sclerosis (MS) and moderately to severely active ulcerative colitis (UC). Zeposia helps to reduce the relapse rate and the number and size of brain lesions in multiple sclerosis. For ulcerative colitis, Zeposia is used to reduce symptoms, and it can also help achieve and maintain remission.

Zeposia is FDA-approved to treat adults with moderately to severely active ulcerative colitis and also FDA-approved to treat relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Multiple sclerosis and ulcerative colitis are both autoimmune disorders where the immune cells (lymphocytes) are thought to incorrectly start attacking your healthy tissue, thinking that it is a foreign substance. In multiple sclerosis, the immune system attacks and damages the myelin sheath that covers the nerves in the brain and spinal cord (CNS). This disrupts the brain from sending signals to the rest of the body and causes symptoms including numbness and tingling in the face, arms, feet, and legs, balance issues and trouble walking, vision problems, bowel and bladder problems, fatigue, and problems thinking and concentrating.

In ulcerative colitis, the immune system attacks and causes inflammation in the lining of the colon which causes the symptoms of abdominal pain, rectal bleeding, bowel urgency, diarrhea, and tiredness. 

How does Zeposia work?

Zeposia is thought to work by preventing immune cells (lymphocytes) from entering the intestines and central nervous system (CNS). It does this by trapping the immune cells in the lymph nodes, which may stop them from causing harmful inflammation in the CNS (in the case of multiple sclerosis) and the colon (in the case of ulcerative colitis). By reducing inflammation that would have been caused by the lymphocytes, the symptoms of these conditions may improve. 

Zepsosia is from a class of medicines called sphingosine 1-phosphate (S1P) receptor modulators. Zeposia has its effect by binding to the S1P1 receptors on a range of cells which is thought to stop the lymphocytes from being able to leave the lymph nodes.

Related/similar drugs

Entyvio, Stelara, Kesimpta, Avonex, dexamethasone, Humira, Remicade

Zeposia side effects

The most common Zeposia side effects are:

• headache, back pain;
• urination problems;
• high or low blood pressure;
• abnormal liver function tests, including high liver enzymes; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

Get emergency medical help if you have signs of an allergic reaction to Zeposia: hives, rash; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• 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;
• pounding in your neck or ears;
• liver problems - nausea, vomiting, upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• vision problems such as increased sensitivity to light, blurred vision, having a blind spot or shadows in the center of your vision, or unusual color to your vision (may occur 3 to 4 months after you start taking Zeposia). S1P receptor modulators, including Zeposia, have been associated with an increased risk of macular edema. Your healthcare provider should send you for an eye examination before starting treatment, 3 to 4 months into treatment, periodically thereafter, and any time there is a vision change. Patients with diabetes or a history of uveitis are more at risk;
• a new darkened area on your skin, a sore that does not heal, a mole that has changed in size or color, or a bump that looks shiny, pearly, or pink. The risk of certain skin cancers, such as basal cell carcinoma and melanoma, is increased in people who take S1P receptor modulators such as Zeposia;
• symptoms of infection - fever, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light.

Serious side effects and warnings

Zeposia may cause the following serious side effects.

Infections: You may get infections more easily, even serious or fatal infections. 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. Your risk of infection could last for 3 months after you stop taking this medicine.

Heart rate: This medicine can slow your heart rate when you start taking it. Tell your doctor if you have slow heartbeats, chest pain, shortness of breath, or feeling like your heart is skipping beats.

Progressive multifocal leukoencephalopathy (PML): Zeposia can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. PML is more likely to happen in people with weakened immune systems but has happened in people who do not have weakened immune systems. Symptoms of PML get worse over days to weeks. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including weakness on one side of your body, loss of coordination in your arms or legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion or changes in your personality.

Liver problems.   Zeposia may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start taking Zeposia and periodically during treatment. Call your healthcare provider right away if you have any of the following symptoms:

• unexplained nausea 
• loss of appetite
• vomiting
• yellowing of the whites of your eyes or skin
• stomach area (abdominal) pain
• dark colored urine
•  tiredness.

Zeposia may increase your blood pressure.  Your healthcare provider should check your blood pressure during treatment with Zeposia.

Breathing problems.  Some people who take Zeposia have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems.

A problem with your vision called macular edema.  Macular edema can cause some of the same vision symptoms as a multiple sclerosis (MS) attack (optic neuritis). You may not notice any symptoms with macular edema. Your healthcare provider should test your vision around the time you start taking Zeposia, periodically while you continue taking Zeposia, and at any time you notice vision changes during treatment with Zeposia. Your risk for macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis. Call your healthcare provider right away if you have any of the following symptoms:

• blurriness or shadows in the center of your vision
• a blind spot in the center of your vision
• sensitivity to light
• unusually colored vision.

Types of skin cancer, including basal cell carcinoma, melanoma, and squamous cell carcinoma.  Tell your healthcare provider if you have any changes in the appearance of your skin, including changes in a mole, a new darkened area on your skin, a sore that does not heal, or growths on your skin, such as a bump that may be shiny, pearly white, skin-colored, or pink. Your doctor should check your skin for any changes at the start of and during treatment with Zeposia. Limit the time you spend in sunlight and ultraviolet (UV) light. Wear protective clothing and use sunscreen with a high sun protection factor.

Swelling and narrowing of blood vessels in your brain.  A condition called PRES (Posterior Reversible Encephalopathy Syndrome) is a rare condition that has happened with Zeposia and with drugs in the same class. Symptoms of PRES usually get better when you stop taking Zeposia. If left untreated, it may lead to a stroke. Your healthcare provider will do a test if you have any symptoms of PRES. Call your healthcare provider right away if you have any of the following symptoms:

• sudden severe headache
• sudden loss of vision or other changes in your vision
• sudden confusion
• seizures.

Severe worsening of multiple sclerosis (MS) after stopping Zeposia.  When Zeposia is stopped, symptoms of MS may return and become worse compared to before or during treatment. Always talk to your healthcare provider before you stop taking Zeposia for any reason. Tell your healthcare provider if you have worsening symptoms of MS after stopping Zeposia.

These are not all of the possible side effects of Zeposia. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking this medicine

You should not use Zeposia if you are allergic to the active ingredient ozanimod or any of the inactive ingredients. To check for a complete list of ingredients, click here: Zeposia ingredients. 

You should not use Zeposia 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
• severe untreated sleep apnea (breathing stops during sleep).

Some heart rhythm medications can cause unwanted or dangerous effects when used with this medicine. Your doctor may change your treatment plan if you also use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol.

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. Wait at least 14 days after stopping an MAO inhibitor before you take Zeposia.

You should not receive live vaccines during treatment with Zeposia, for at least 1 month before starting treatment, and for 3 months after you stop treatment. Vaccines may not work as well when given during treatment with Zeposia.

You may need medical tests before and while taking this medicine including blood tests, tests to check your heart function, blood pressure, vision exams, liver function tests, and skin exams.

Tell your doctor if you have received any vaccine within the past 30 days or if you are scheduled to receive a vaccine.

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);
• a very slow heart rate;
• heart rhythm problems, long QT syndrome;
• a heart attack, stroke, or chest pain;
• high blood pressure;
• sleep apnea or other breathing problems;
• diabetes;
• skin cancer;
• liver disease; or
• an eye condition called uveitis.

Before taking this medicine, you should have a complete blood count, a cardiac evaluation, liver function tests, and an ophthalmic assessment. Your doctor will check your current or prior medication, your vaccination history, and whether you have a confirmed history of chickenpox.

Pregnancy

Zeposia may harm an unborn baby. Tell your doctor if you are planning a pregnancy or are pregnant. Use effective birth control while using this medicine and for at least 3 months after your last dose.

If you become pregnant while taking Zeposia pregnant, talk to your healthcare provider about registering with the Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby's health.

Breastfeeding

It is not known if Zeposia passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you taking this medicine.

How should I take Zeposia?

Take Zeposia exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

This medicine can slow your heart rate when you start taking it. Before your first dose, your heart function will be checked using an electrocardiograph or ECG (sometimes called an EKG).

Zeposia comes in a 7-day starter pack containing capsules of different colors and strengths. You should follow the dosing schedule as prescribed by your doctor. This may lower the risk of side effects.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests, and your risk of infection could last for 3 months after you stop taking this medicine.

If you get an infection, further doses may be delayed until your infection clears up.

Always ask your doctor before you stop taking this medicine for any reason. Your symptoms may return and become worse than before or during treatment with this medicine. Tell your doctor if you have any signs of worsening symptoms.

Zeposia Instructions

• You will receive a 7-day starter pack. You must start this medicine by slowly increasing doses over the first week. See the table below for more detailed information.
• Take Zeposia 1 time each day.
• Swallow the Zeposia capsule whole.
• Take the capsule with or without food. 
• You should not stop treatment without talking with your healthcare provider first.
• Take your medicine every day - do not skip a dose.
• If you miss 1 or more days of your dose during the first 14 days of treatment, talk to your healthcare provider. You will need to begin with another 7-day starter pack.
• If you miss a dose after the first 14 days of treatment, take the next scheduled dose the following day.

Follow the dose schedule in the table below. This may reduce the risk of slowing of the heart rate.

Dosing information

Usual Adult Dose for Multiple Sclerosis

Dose titration regimen

• Day 1 to day 4: 0.23 mg capsule once a day.
• Day 5 to day 7: 0.46 mg capsule once daily.
• Day 8 and thereafter: 0.92 mg capsule once a day.

Maintenance dose:

•  0.92 mg capsule once daily starting on Day 8.

Uses:

• For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive. 

Usual Adult Dose for Ulcerative Colitis

Dose titration regimen

• Days 1 to day 4: 0.23 mg capsule once a day.
• Days 5 to day 7: 0.46 mg capsule once daily.
• Day 8 and thereafter: 0.92 mg capsule once a day.

Maintenance dose

• 0.92 mg capsule once daily starting on Day 8.

Uses:

• For the treatment of moderately to severely active ulcerative colitis.

Zeposia is available as

Capsules:

• 0.23 mg capsule (light grey opaque body/light grey opaque cap imprinted with black ink "OZA" on the cap and "0.23 mg" on the body)
• 0.46 mg capsule (light grey opaque body/orange opaque cap imprinted with black ink "OZA" on the cap and "0.46 mg" on the body)
• 0.92 mg capsule (orange opaque body/orange opaque cap imprinted with black ink "OZA" on the cap and "0.92 mg" on the body)

What happens if I miss a dose?

Call your doctor for instructions. 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.

If you miss a dose after the first 2 weeks: Skip the missed dose and use your next dose at the regular time.

Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Zeposia?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid getting a vaccine without first asking your doctor. While you are taking this medicine, a "live" vaccine may not fully protect you from disease and you could develop an infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). You should not receive a live vaccine within 1 month before taking Zeposia, while taking it, and for at least 3 months after you stop taking it.

What other drugs will affect Zeposia?

Zeposia can cause a serious heart problem and 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.

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;
• heart rhythm medicine;
• medicine to treat Parkinson's disease; or
• opioid pain medicine
• MAO inhibitors such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine. 
• amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol.

Zeposia can have long-lasting effects on your body, especially on your immune system. For at least 4 weeks after your last dose, tell any doctor who treats you that you have used this medicine.

This list is not complete and many other medications may also interact with Zeposia so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. To check for interactions with Zeposia click on the link below.

Ingredients

Active ingredient: ozanimod

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.

The capsule shell contains black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide.

Storage

• Store at room temperature between 68°F to 77°F (20°C to 25°C).

Manufacturer

Marketed by: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA.

Zeposia® is a trademark of Celgene Corporation, a Bristol-Myers Squibb company.

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