Fingolimod oral capsules

What is this medicine?

FINGOLIMOD (fin GOL i mod) helps prevent relapses of multiple sclerosis. The medicine does not cure multiple sclerosis.

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. While this drug may be prescribed for children as young as 10 years, precautions do apply.

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

• confusion

• headache with fever, neck stiffness, sensitivity to light, nausea, or confusion

• loss of memory

• problems with balance, talking, or walking

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• change in your skin's appearance (color, change in a mole or freckle, new growth)

• seizures

• sudden numbness or weakness of the face, arm or leg

• unusually slow heartbeat

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

• diarrhea

• headache

• pain in legs or arms

• sinus trouble

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

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.

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.

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

• skin cancer

• recently received or scheduled to receive a vaccine

• uveitis

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

• pregnant or trying to get pregnant

• breast-feeding

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

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

After the first dose, you will be watched for at least 6 hours. Children will also be watched for at least 6 hours if their dose is increased. If you miss more than 1 dose, you may need to be watched by a health care professional when you take your next dose; do not start taking it again without talking with your doctor.

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

This medicine 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 use sunscreen. Do not use sun lamps or tanning beds/booths.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. If you are a female who can become pregnant, you should use effective birth control during your treatment with this medicine and for at least 2 months after you stop taking it. Talk to your health care professional or pharmacist for more information.

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