Ozanimod (oh-ZAN-i-mod)

Treats multiple sclerosis (MS) and ulcerative colitis.

Brand Name(s):

Zeposia, Zeposia 7-Day Starter Pack, Zeposia Starter Kit

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole. Do not crush or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you missed a dose during the first 2 weeks of treatment, you may need to restart taking the medicine. If you missed a dose after the first 2 weeks of treatment, take it as soon as you remember, then go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take this medicine if you are also using an MAO inhibitor (including linezolid, phenelzine, selegiline), or after receiving alemtuzumab within the past 14 days.
• Some foods and medicines can affect how ozanimod works. Tell your doctor if you are using any of the following:
  • Gemfibrozil, rasagiline, rifampin
  • Medicine for depression (including SNRIs, SSRIs, TCA)
  • Medicine for heart rhythm problems (including amiodarone, procainamide, quinidine, sotalol)
  • Medicine that weakens the immune system (including beta interferon, glatiramer acetate, cancer medicine, steroid medicine)
  • Narcotic medicine (including meperidine, methadone, tramadol)
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Live virus vaccines should be given at least 3 months after your last dose of this medicine.
• Avoid foods and drinks that are high in tyramine, because your blood pressure could get dangerously high. Your doctor should give you a complete list. In general, do not eat anything aged or fermented, such as most cheese, most alcohol, cured meat (such as salami), sauerkraut, and soy sauce. Check the expiration dates on packages. Tyramine levels get higher as food gets older or if it has not been refrigerated properly.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective birth control during treatment and for at least 3 months after the last dose of this medicine.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, breathing problems, high blood pressure, any type of infection (including chickenpox), a weak immune system, or a history of diabetes or uveitis (eye swelling).
• This medicine may cause the following problems:
  • Increased risk of infections, which may be life-threatening (including meningitis, herpes, progressive multifocal leukoencephalopathy)
  • Heart rhythm problems
  • Lung or breathing problems
  • Liver problems
  • Increased risk of macular edema (swelling at the back of your eye)
  • Increased risk of skin cancer (including basal cell carcinoma, melanoma, squamous cell carcinoma)
  • Brain problems, including posterior reversible encephalopathy syndrome (PRES)
• Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor will also check your skin for any changes before and during treatment with this medicine.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or other changes in vision
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, dizziness, lightheadedness
• Fast, slow, or uneven heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Painful blisters on trunk of the body
• Sudden or severe headache, confusion, seizures
• Trouble breathing, chest tightness
• Unusual bleeding, bruising, or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088