Fingolimod (fin-GOL-i-mod)

Treats flare-ups of multiple sclerosis (MS).

Brand Name(s):

Gilenya, Tascenso ODT

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Dissolving Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Your doctor will give you the first dose of this medicine. You may need to stay in the hospital or clinic for at least 6 hours after the first dose to check for unwanted effects.
• Disintegrating tablet: Do not open the blister pack until you are ready to take the tablet. Make sure your hands are dry and peel back the foil to remove the tablet. Do not push the tablet through the foil. Place the tablet on your tongue and let it melt. Do not take the medicine with liquid.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you missed a 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 this medicine together with 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, digoxin, diltiazem, erythromycin, haloperidol, ketoconazole, methadone, mitoxantrone, natalizumab, teriflunomide, verapamil
  • Beta-blockers
  • Medicine the weakens the immune system (including beta interferon, glatiramer acetate, cancer medicine, steroid medicine)
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Avoid receiving live vaccines during treatment with this medicine and for 2 months after the last dose.

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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use effective birth control during treatment and for 2 months after your last dose.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, diabetes, any type of infection (including chickenpox) or an infection that keeps coming back, or a history of uveitis (swelling 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 other 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:
  • Heart rhythm problems
  • Macular edema (swelling in the eye)
  • Progressive multifocal leukoencephalopathy (PML, a brain infection that can be life-threatening)
  • Posterior reversible encephalopathy syndrome (swelling in the brain)
  • Lung or breathing problems
  • Liver problems
  • High blood pressure
  • Increased risk of skin cancer (including basal cell carcinoma, melanoma, squamous cell carcinoma) or lymphoma
  • Brain problems, including posterior reversible encephalopathy syndrome (PRES)
• Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.
• This medicine may cause a severe increase in disability (including worsening of MS symptoms) for at least 12 to 24 weeks after stopping the medicine. Talk to your doctor if you have concerns about this.
• 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.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor will also check your skin for any changes before and during treatment with this medicine.
• 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
• Difficulty controlling your bladder or bowels, trouble walking, swallowing, or speaking, numbness or tingling in your arms, legs, or face
• 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 these less serious side effects, talk with your doctor:

• Diarrhea, stomach pain
• Pain in the arms, legs, or back

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