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Fingolimod (By mouth)

Fingolimod (fin-GOL-i-mod)

Reduces frequency of flare-ups (relapses) in people who have multiple sclerosis (MS).

Brand Name(s):

Gilenya

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you have had an allergic reaction to fingolimod. Do not use this medicine if you have had severe chest pain, heart failure, heart attack, or stroke within the past 6 months. You should not use this medicine if you also have a heart rhythm problem (such as QT prolongation) or have heart block or sick sinus syndrome (without a pacemaker). Do not use this medicine if you use medicine for heart rhythm problems, such as amiodarone, disopyramide, dofetilide, procainamide, quinidine, sotalol, Betapace®, Cardioquin®, Cordarone®, Norpace®, Procanbid®, Quinaglute®, or Tikosyn®.

How to Use This Medicine:

Capsule

  • Take your medicine as directed.
  • Your first dose of fingolimod will be given in a hospital or clinic where you will be observed for at least 6 hours or overnight. You may also be watched for any serious side effects for at least 6 hours after you take your second dose of this medicine the next day.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

  • You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.
  • Call your doctor right away if you miss a dose during the first 2 weeks you are taking this medicine. If you miss more than 7 doses in a row after the first 2 weeks, call your doctor right away.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

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

  • Make sure your doctor knows if you also use arsenic trioxide (Trisenox®), cisapride (Propulsid®), digoxin (Lanoxin®), ketoconazole (Nizoral®), certain blood pressure medicine (such as atenolol, diltiazem, metoprolol, propranolol, verapamil, Cardizem®, Inderal®, Tenormin®, or Toprol®), medicine for depression (such as amitriptyline, fluoxetine, nortriptyline, Elavil®, Pamelor®, Prozac®, Sarafem®, or Vivactil®), certain antibiotics (such as erythromycin, levofloxacin, moxifloxacin, sparfloxacin, Avelox®, Levaquin®, or Zagam®), or medicine to treat mental illness (such as haloperidol, mesoridazine, pimozide, prochlorperazine, quetiapine, thioridazine, ziprasidone, Compazine®, Geodon®, Haldol®, Mellaril®, Orap®, Serentil®, or Seroquel®).
  • Make sure your doctor knows if you are receiving a medicine that weakens your immune system. This may include cancer medicines or other medicines for multiple sclerosis (such as mitoxantrone, natalizumab, Novantrone®, or Tysabri®).
  • This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

  • You can harm your unborn baby if you use this medicine while you are pregnant. Use an effective form of birth control to avoid pregnancy. You should not become pregnant while you are taking this medicine and for 2 months after you stop taking it. Tell your doctor right away if you think you have become pregnant while you are using this medicine.
  • Make sure your doctor knows if you are breastfeeding or if you have kidney disease, liver disease, heart disease, congestive heart failure, high blood pressure, low potassium or magnesium in the blood, or a history of fainting. Tell your doctor if you have breathing problems (including sleep apnea), diabetes, a history of uveitis or eye problems, any infection, or have had chickenpox.
  • This medicine may cause your heart rate to slow down. After you take your first dose, you will be observed in a hospital or clinic for 6 hours for signs and symptoms of bradycardia (slow heartbeat). Symptoms may include chest pain, lightheadedness, dizziness, fainting, trouble breathing, or unusual tiredness. Check with your doctor right away if you have any of these symptoms while you are taking this medicine.
  • This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of infection. If you can, avoid people with infections. Check with your doctor immediately if you have any symptoms of an infection, such as a fever or chills, cough, sore throat, or painful or difficult urination.
  • You should receive a varicella zoster virus (VZV) vaccine at least 1 month before you start treatment with this medicine if you have not had chickenpox. Ask your doctor if you have any questions.
  • This medicine may cause macular edema (swelling of the back of the eye), especially during the first 3 to 4 months of treatment. Check with your doctor immediately if blurred vision, difficulty reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor to check your eyes.
  • Check with your doctor right away if you have upper stomach pain, pale stools, dark urine, loss of appetite, nausea, unusual tiredness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.Blood tests and tests for heart function may be needed to check for side effects.

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
  • Changes in vision
  • Dark-colored urine or pale stools
  • Fever, chills, cough, sore throat, and body aches
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach
  • Slow or uneven heartbeat
  • Trouble breathing
  • Yellow skin or eyes

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

  • Back pain
  • Diarrhea
  • Headache
  • Stuffy or runny nose

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: 7/4/2014


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