When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to fingolimod.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use fingolimod if you also use medicine for heart rhythm problems.
• Some medicines can affect how fingolimod works. Tell your doctor if you are using any of the following:
  
  • Chlorpromazine, citalopram, erythromycin, haloperidol, ketoconazole, methadone, mitoxantrone, natalizumab, teriflunomide
  • Beta-blocker medicine or other medicine that affects your heart or blood pressure, including digoxin, diltiazem, or verapamil
  • Steroid medicine, including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for 2 months after you stop using it.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, diabetes, or a history of uveitis (inflammation in the eye).
• This medicine may cause slow or uneven heartbeat. Because of this side effect, tell your doctor about any heart or circulation problems you have, including heart disease, high blood pressure, heart attack, stroke, heart failure, heart block, angina, or rhythm problems (including sick sinus syndrome or long QT). Also tell your doctor if you have sleep apnea or a history of repeated fainting.
• This medicine may cause the following problems:
  
  • Macular edema (swelling in the eye)
  • Liver problems
  • Progressive multifocal leukoencephalopathy (PML, a brain infection that can be life-threatening)
  • Posterior reversible encephalopathy syndrome (swelling in the brain)
  • Basal cell carcinoma (skin cancer)
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick. Reported infections include bronchitis, pneumonia, varicella zoster, or herpes simplex. This risk could last up to 2 months after you stop fingolimod treatment.
• Do not stop taking this medicine and then start again without talking to your doctor. Your heartbeat may need to be monitored.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, trouble seeing, sensitivity to light, or other vision changes
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches, headache, stiff neck
• Lightheadedness, dizziness, fainting
• Skin growths, patches or sores on the skin that do not heal quickly
• Sudden and severe headache, confusion, seizures
• Swollen glands in your armpits, neck, or groin
• Trouble breathing
• Weakness on one side of your body, trouble thinking, trouble seeing, clumsiness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088