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Generic Name: fingolimod (fin-GOL-i-mod)
Brand Name: Gilenya

Gilenya is used for:

Reducing the number of relapses and delaying disability in certain patients with multiple sclerosis (MS).

Gilenya is a sphingosine 1-phosphate receptor modulator. Exactly how it works is not known, but it is thought to work by decreasing the number of certain white blood cells (lymphocytes) that enter the central nervous system (CNS).

Do NOT use Gilenya if:

  • you are allergic to any ingredient in Gilenya
  • you have an active infection, including a long-term infection
  • you have had a heart attack, unstable angina, stroke, transient ischemic attack (TIA) ("mini-stroke"), or certain types of heart failure in the last 6 months
  • you have a history of certain types of irregular heartbeat (eg, heart block, sick sinus syndrome) and you do not have a pacemaker
  • you have a certain type of irregular heartbeat (prolonged QT interval, congenital QT prolongation)
  • you are taking certain antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, sotalol)

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Gilenya:

Some medical conditions may interact with Gilenya. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have or have had a history of a slow heart rate, high or low blood pressure, low blood potassium or magnesium levels, or heart problems (eg, irregular heartbeat, heart block, heart failure)
  • if you have a history of heart attack, angina, stroke, TIA, or blood vessel problems (eg, in the heart or brain)
  • if you have a history of an infection that keeps coming back, fainting, eye problems (eg, an inflammation called uveitis, macular edema), lung or breathing problems (eg, sleep apnea), liver or kidney problems, high cholesterol or triglyceride levels, or diabetes
  • if you have a weakened immune system or a fever, an infection, or you have not had chickenpox or the chickenpox vaccination
  • if you have had a vaccine within 1 month before you start Gilenya or if you are scheduled to have a vaccine
  • if you have recently received or will be receiving chemotherapy or radiation treatments, or you are taking corticosteroids (eg, prednisone)
  • if you have taken another medicine for MS (eg, natalizumab) within the past 2 to 3 months
  • if you are taking any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Gilenya. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, sotalol), beta-blockers (eg, atenolol, metoprolol), beta-2 receptor agonists (eg, salmeterol), chloroquine, chlorpromazine, cholinesterase inhibitors (eg, galantamine), citalopram, digoxin, diltiazem, domperidone, fluoxetine, haloperidol, macrolide antibiotics (eg, erythromycin), methadone, ondansetron, pilocarpine, quinine, quinolone antibiotics (eg, ciprofloxacin), tacrolimus, tetracyclic antidepressants (eg, maprotiline), tricyclic antidepressants (eg, amitriptyline), tyrosine kinase inhibitors (eg, sunitinib), verapamil, or vorinostat because the risk of slow or irregular heartbeat may be increased
  • Medicine for cancer, corticosteroids (eg, prednisone), medicine that may weaken your immune system, or other medicines for MS (eg, interferon beta, mitoxantrone, natalizumab) because the risk of infection may be increased
  • Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin), protease inhibitors (eg, ritonavir), or telithromycin because they may increase the risk of Gilenya's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gilenya may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gilenya:

Use Gilenya as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Gilenya comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Gilenya refilled.
  • Take Gilenya by mouth with or without food.
  • Your first dose of Gilenya will be given in a doctor's office, hospital, or clinic. You will be observed for at least 6 hours following your first dose.
  • Take Gilenya on a regular schedule to get the most benefit from it. Taking Gilenya at the same time each day will help you remember to take it.
  • Continue to take Gilenya even if you feel well. Do not miss any doses.
  • If you miss a dose of Gilenya, call your doctor to find out what to do.

Ask your health care provider any questions you may have about how to use Gilenya.

Important safety information:

  • Do not drive or perform other possibly unsafe tasks during the first day of treatment until you know how you react to Gilenya.
  • Slow heartbeat may occur after you start Gilenya, especially after your first dose. Your health care provider will watch you for symptoms of slow heartbeat for at least 6 hours after your first dose. Symptoms can happen up to 24 hours after you take your first dose of Gilenya. If you experience slow heartbeat, your heart rate will usually return to normal within 1 month after you start Gilenya. Tell your doctor right away if you experience chest, pain, dizziness, seizures, slow or irregular heartbeat, or unusual tiredness.
  • Do NOT take more than the recommended dose, change your dose, or stop taking Gilenya without checking with your doctor.
  • Gilenya may lower the ability of your body to fight infection while you take it and for up to 2 months after you stop taking it. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Gilenya and for up to 2 months after you stop taking it. Talk with your doctor before you receive any vaccine.
  • A serious and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has occurred with the use of Gilenya. Contact your doctor at once if you develop symptoms like vision problems, confusion, trouble thinking, severe headache, or seizures. Talk with your doctor for more information.
  • Women who may become pregnant should use an effective form of birth control while they take Gilenya and for 2 months after they stop taking Gilenya. If you have questions about effective birth control, talk with your doctor.
  • Tell your doctor or dentist that you use Gilenya before you receive any medical or dental care, emergency care, or surgery.
  • Gilenya may interfere with certain lab tests, including peripheral blood lymphocyte counts. Be sure your doctor and lab personnel know you are taking Gilenya.
  • You will need to watch your heart rate and blood pressure as your doctor has told you.
  • Lab tests, including electrocardiograms (ECGs), complete blood cell counts, pulse and blood pressure, lung function, liver function, and eye exams, may will be performed while you use Gilenya. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Gilenya may cause harm to the fetus. Do not become pregnant while you are using it or for 2 months after you stop using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gilenya while you are pregnant. It is not known if Gilenya is found in breast milk. Do not breast-feed while taking Gilenya.

Possible side effects of Gilenya:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; diarrhea; flu-like symptoms; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the skin; chest pain; confusion; depression; dizziness; eye pain; fainting; feeling cold in the hands or feet; new or worsening breathing problems (eg, shortness of breath); one-sided weakness; severe or persistent headache; slow or irregular heartbeat; skin or nail infection (eg, skin discharge, redness, swelling, or warmth); slurred speech; symptoms of infection (eg, fever, chills, cough, sore throat, body aches, nausea or vomiting, increased or painful urination); symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; severe or persistent nausea, vomiting, or stomach pain; yellowing of the skin or eyes); unexpected weight loss; unusual tiredness or weakness; vision changes (eg, blurred vision, shadows, blind spot, sensitivity to light, unusually colored or tinted vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Gilenya:

Store Gilenya at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in the original blister pack away from heat, moisture, and light. Do not store in the bathroom. Keep Gilenya out of the reach of children and away from pets.

General information:

  • If you have any questions about Gilenya, please talk with your doctor, pharmacist, or other health care provider.
  • Gilenya is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Gilenya or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Gilenya. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gilenya. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Gilenya.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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