Zeposia Starter Kit (28-day) 0.23 mg-0.46 mg-0.92 mg capsules dosepack

The photos shown are samples only

Generic name:
Ozanimod - oral

Pronunciation
(oh-ZAN-i-mod)

Brand name(s)
Zeposia

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. Slow heartbeat may also occur, especially when you first start this medication. 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.

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.

Tell your doctor right away if you have any serious side effects, including:

signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
shortness of breath
unusual tiredness

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 of these side effects:

clumsiness
loss of coordination/balance
weakness
sudden change in your thinking (such as confusion, difficulty concentrating, memory loss)
difficulty talking/walking
seizure

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

very slow heartbeat
fast/irregular heartbeat
severe dizziness
fainting
eye pain/sensitivity to light
vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes)
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 breastfeeding.

Drug interactions