Uses

This medication is used to treat multiple sclerosis (MS). Ozanimod is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of disease worsening (relapses) and may prevent or delay disability.

Ozanimod is also used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain.

How To Use

Read the Medication Guide provided by your pharmacist before you start taking ozanimod and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once a day or every other day. Swallow the capsule whole.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time on the days you are scheduled to take the medication.

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Do not stop taking this medication without consulting your doctor. Your condition may become worse when this drug is suddenly stopped. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.

The manufacturer recommends you avoid certain foods and beverages that are high in tyramine, since these may increase your blood pressure while you are taking ozanimod. These include: aged cheeses, dried/aged meats and sausages (such as salami, liverwurst), preserved fish (such as pickled herring), products that contain large amounts of yeast (such as bouillon cubes, powdered soup/gravy, homemade or sourdough bread), fermented foods (such as sauerkraut, kim chee), most soybean products (such as soy sauce, tofu), broad/fava beans, red wine, sherry, tap beers, vermouth, among others. Ask your doctor or dietician for more details and for a list of foods to limit or avoid.

Tell your doctor if your condition gets worse.

Side Effects

Back pain, dizziness, and lightheadedness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

When you first start taking ozanimod, you may have temporary slowing of your heartbeat. To decrease your risk, your doctor may slowly increase your dose during the first 8 days of treatment (see also How to Use).

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

This medication may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as:

• nausea/vomiting that doesn't stop
• loss of appetite
• stomach/abdominal pain
• yellowing eyes/skin
• dark urine

This medication can weaken your immune system/increase the risk of infection while you are taking it and for 3 months after your last dose. You may be more likely to get a serious (possibly fatal) infection (such as bronchitis, herpes). Tell your doctor right away if you develop any signs of an infection such as sore throat/cough that doesn't go away, difficulty breathing, fever/chills, cold/flu symptoms, sores, or blisters. Do not start ozanimod if you already have an infection.

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Symptoms of PML can seem like a worsening MS attack. Get medical help right away if you have any new or worsening symptoms that have lasted for several days, such as clumsiness or problems with strength, balance, speech, eyesight, or thinking.

Get medical help right away if you have any very serious side effects, including:

• shortness of breath
• severe dizziness/fainting
• unusual tiredness/weakness
• eye pain/sensitivity to light
• vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes)
• mental changes (such as sudden confusion)
• seizure
• sudden/severe headache

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking ozanimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• breathing problems (such as asthma, bronchitis, emphysema, sleep apnea)
• current/recent/returning infection (including hepatitis and tuberculosis)
• diabetes
• certain eye problems (macular edema, uveitis)
• heart problems (such as slow/irregular heartbeat, heart failure, previous heart attack, chest pain, QT prolongation in the EKG)
• high blood pressure
• liver problems
• smoking
• stroke/mini-stroke

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Ozanimod can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. If a live vaccine is needed, it should be given at least one month before starting this medication. Tell your health care professional that you are using ozanimod before having any immunizations/vaccinations. Avoid getting a live vaccine while using this medication and for 3 months after the last dose of this medication. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ozanimod. Ozanimod may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 3 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab, alemtuzumab)

Do not take any MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, blood pressure, pulse, EKG, MRI, eye exams, liver function tests, lung/breathing tests) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

It is very important to follow your treatment schedule as directed by your doctor. Ask your doctor ahead of time what you should do if you miss a dose of ozanimod. If you miss a dose during the first 14 days of treatment, you may need to start at a lower dose again and slowly increase it. If you miss a dose after the first 14 days of treatment, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.