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. 

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.

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 Zeposia capsule whole.
• Take the capsule with or without food. But you should avoid certain foods that are high (over 150 mg) in tyramine such as aged, fermented, cured, smoked and pickled foods. Eating these foods while taking Zeposia may increase your blood pressure.
• 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.

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)

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.

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;
• 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 a 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.

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.

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

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.

Get emergency medical help if you have signs of an allergic reaction to Zeposia: hives, rash; difficult 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);
• 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
• symptoms of infection - fever, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light.

Common Zeposia 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.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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;
• an antidepressant;
• 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.