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Fingolimod (By mouth)

Fingolimod (fin-GOL-i-mod)

Treats flare-ups of multiple sclerosis.

Brand Name(s):

Gilenya

There may be other brand names for this medicine.

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, or if you have abnormal heart rhythms (such as QT prolongation, heart block, or sick sinus syndrome without a pacemaker) or had severe chest pain, a heart attack, or a stroke within the past 6 months.

How to Use This Medicine:

Capsule

  • Take your medicine as 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 this medicine if you also use certain medicine for heart rhythm problems.
  • Some medicines can affect how fingolimod works. Tell your doctor if you are using chlorpromazine, citalopram, digoxin, diltiazem, erythromycin, haloperidol, ketoconazole, methadone, mitoxantrone, natalizumab, verapamil, or a beta blocker.
  • 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 birth control to prevent pregnancy while you are taking this medicine and for 2 months after you stop taking it.
  • Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, heart disease, heart failure, high blood pressure, or a history of fainting. Tell your doctor if you have breathing problems (including sleep apnea), diabetes, a history of uveitis (inflamed eye), an infection, or if you had chickenpox or a vaccine to prevent chickenpox.
  • This medicine may cause the following problems:
    • Slow heart rate
    • Macular edema (swelling of the back of the eye)
    • Posterior reversible encephalopathy syndrome (a type of brain swelling)
    • Liver problems
  • This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Avoid people who are ill, and wash your hands often. Brush and floss your teeth gently, do not play rough sports, and be careful with sharp objects.
  • 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, sensitivity to light, or other vision changes
  • Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
  • Dizziness or tiredness
  • Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
  • Slow or uneven heartbeat
  • Sudden and severe headache, confusion, loss of vision, seizures
  • Trouble breathing

If you notice these less serious side effects, talk with your doctor:

  • Back pain
  • Diarrhea
  • Headache

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


Last Updated: 10/4/2014


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