Fingolimod Oral capsule

What is this medicine?

FINGOLIMOD (fin GOL i mod) may help prevent relapses of multiple sclerosis. 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.

What should I tell my health care provider before I take this medicine?

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

• diabetes

• heart disease

• high blood pressure

• history of irregular heartbeat

• history of stroke

• immune system problems

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• lung or breathing disease, like asthma

• uveitis

• an unusual or allergic reaction to fingolimod, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

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 pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've 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?

It is important not to miss any doses. If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• arsenic trioxide

• certain antipsychotics like pimozide, thioridazine, ziprasidone

• certain medicines for irregular heart beat like amiodarone, disopyramide, dofetilide, ibutilide, procainamide, propafenone, quinidine, sotalol

• certain medicines used for nausea like chlorpromazine, droperidol

• certain medicines used to treat infections like chloroquine, clarithromycin, erythromycin, pentamidine

• cisapride

• dextromethorphan; quinidine

• dronedarone

• methadone

• posaconazole

• saquinavir

This medicine may also interact with the following medications:

• beta-blockers like metoprolol and propranolol

• citalopram

• digoxin

• diltiazem

• haloperidol

• ketoconazole

• live virus vaccines

• medicines that lower your chance of fighting infection

• mitoxantrone

• natalizumab

• verapamil

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 medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

After the first dose, you will be watched for at least 6 hours. If you miss more than 1 dose within the first 2 weeks of treatment, if you do not take it for more than 7 days during weeks 3 or 4 of treatment, or if you do not take this medicine for at least 2 weeks after taking it for at least a month, do not start taking it again without talking with your doctor. You will need to be watched again for at least 6 hours after the first dose.

This medicine may stay in your body for up to 2 months after your last dose. Tell your doctor about any unusual symptoms. If you're a woman, do not get pregnant for at least 2 months after your last dose. If you do get pregnant, tell your doctor.

Tell your doctor or health care professional right away if you have any change in your eyesight.

Talk with your doctor if you have not had chickenpox or the vaccine for chickenpox.

Your vision and blood may be tested before and during use of this medicine.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• chest pain or palpitations

• dark urine

• dizziness or fainting

• feeling faint or lightheaded, falls

• fever or chills, sore throat

• general ill feeling or flu-like symptoms

• light-colored stools

• loss of appetite

• nausea

• right upper belly pain

• unusually slow heartbeat

• unusually weak or tired

• yellowing of the eyes or skin

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

• back pain

• cough

• diarrhea

• headache

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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

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.