Ozanimod capsules

What is this medication?

OZANIMOD (oh ZAN i mod) helps prevent relapses of multiple sclerosis. It is also used to treat ulcerative colitis. This medicine is not a cure.

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 disease, such as uveitis
• heart disease
• high blood pressure
• immune system problems
• infection especially a viral infection such as chickenpox, cold sores, or herpes
• irregular heartbeat or rhythm
• liver disease
• low blood counts (white cells, platelets, or red blood cells)
• recent or upcoming vaccine
• skin cancer/melanoma
• sleep apnea
• stroke or transient ischemic attack
• an unusual or allergic reaction to ozanimod, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine 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 medicine. 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 health care provider 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 health care provider about the use of this medicine 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 healthcare provider. 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 medicine with any of the following medications:

• linezolid
• MAOIs like Azilect, Carbex, Eldepryl, Marplan, Nardil, Parnate, and Xadago

This medicine may also interact with the following medications:

• certain medicines for blood pressure, heart disease, irregular heart beat
• certain medicines for depression, anxiety, or psychotic disorders
• gemfibrozil
• live virus vaccines
• medicines that lower your chance of fighting infection
• other medicines that prolong the QT interval (abnormal heart rhythm)
• narcotic medicines for pain
• pseudoephedrine
• rifampin
• stimulant medicines for attention disorders, weight loss, or staying awake
• tyramine

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 while you are taking this medication.

Foods that contain very high amounts of tyramine, such as aged, fermented, cured, smoked and pickled foods, should be avoided while taking this medication. The combination may cause a dangerous rise in blood pressure. Ask your care team for a complete listing of foods and beverages that are high in tyramine. If you consume a food or beverage very rich in tyramine and do not feel well soon after eating, contact your care team.

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.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths.

Do not become pregnant while taking this medication or for 3 months after stopping it. Women should inform their care team if they wish to become pregnant or think they might be pregnant. There is potential for serious harm to an unborn child. Talk to your care team for more information.

If you stop taking this medication for MS, your symptoms may get worse. You may have more weakness, trouble using your arms or legs, or changes in balance. Talk to your care team right away if your symptoms get worse.

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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• changes in vision
• heartbeat rhythm changes (trouble breathing; chest pain; dizziness; slow, irregular heartbeat; feeling faint or lightheaded, falls)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• severe headache with confusion, changes in vision, or seizure
• trouble breathing

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

• back pain
• dizziness
• sinus trouble

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 medicine after the expiration date.

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

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine 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.