Ozanimod Capsules

What is this medication?

OZANIMOD (oh ZAN i mod) treats multiple sclerosis (MS). It works by slowing down an overactive immune system, which prevents or delays worsening symptoms. It also decreases the number of flare-ups. It may also be used to treat ulcerative colitis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ZEPOSIA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Eye conditions, such as eye inflammation
• Have had a heart attack, stroke, or mini-stroke
• Heart disease
• High blood pressure
• Infection, especially a viral infection, such as chickenpox, cold sores, or herpes
• Irregular heartbeat or rhythm
• Liver disease
• Recent or upcoming vaccine
• Skin cancer or melanoma
• Sleep apnea
• Weakened immune system
• An unusual or allergic reaction to ozanimod, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss 1 or more doses during the first 14 days of treatment, talk to your care team. You will need to begin another starter pack.

If you miss a dose after the first 14 days of treatment, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Dengue vaccine
• Dronedarone
• Ketoconazole
• Levoketoconazole
• Linezolid
• MAOIs, such as Marplan, Nardil, and Parnate
• Pimozide
• Rasagiline
• Safinamide
• Selegiline
• St. John's wort
• Thioridazine

This medication may also interact with the following:

• Certain medications for blood pressure, heart disease, irregular heartbeat
• Live virus vaccines
• Medications that lower your chance of fighting infection

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

Your vision may be tested before and during use of this medication. Tell your care team right away if you have any change in your eyesight.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Talk to your care team if you have not had chickenpox or the vaccine for chickenpox. To lower your risk of infection, you may need to get vaccinated before you start this medication.

This medication can decrease the response to a vaccine. If you need to get vaccinated, tell your care team if you have received this medication within the last 3 months. Talk to your care team to see if a different vaccination schedule is needed.

In some patients, this medication may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your care team right away. If you cannot reach your care team, urgently seek another source of medical care.

Talk to your care team about your risk of skin cancer. You may be more at risk for skin cancer if you take this medication. To lower your risk, keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

If you take this medication for multiple sclerosis (MS) and stop taking it, your symptoms may get worse. Talk to your care team right away if you have worsening muscle weakness or loss of balance or coordination.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 3 months after the last dose. Contraception is recommended while taking this medication and for 3 months after the last dose. Your care team can help you find the option that works for you.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Fever, neck pain or stiffness, sensitivity to light, headache, nausea, vomiting, confusion, which may be signs of meningitis
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Shortness of breath
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Back pain
• Headache
• Joint pain
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.