Gilenya

Pronunciation: fin-GOL-i-mod
Generic Name: Fingolimod
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

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

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 taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a slow heart rate (less than 55 beats per minute), high blood pressure, or heart problems (eg, irregular heartbeat, heart block, sick sinus syndrome, prolonged QT interval, heart failure)


• if you have a history of long-term infection or an infection that keeps coming back, fainting, eye problems (eg, an inflammation called uveitis, macular edema), lung or breathing problems, liver or kidney problems, or diabetes


• if you have a weakened immune system, a fever, or you have not had chickenpox or the chickenpox vaccination


• if you have had a vaccine within 1 month before you start Gilenya

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, procainamide, quinidine, sotalol), beta-blockers (eg, atenolol), or calcium channel blockers (eg, diltiazem) because the risk of slow or irregular heartbeat may be increased


• Medicine for cancer, medicine that may weaken your immune system, or other medicines for MS (eg, mitoxantrone, natalizumab) because the risk of infection may be increased


• Ketoconazole because it 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 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, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss taking Gilenya for more than 2 weeks, contact your doctor before you start to take it again.

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

Important safety information:

• 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 6 hours after your first dose. 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 dizziness, slow or irregular heartbeat, or unusual tiredness.


• Do NOT take more than the recommended dose 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.


• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.


• 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.


• Cases of a certain type of blood cancer (lymphoma) have occurred in patients taking Gilenya. It is not known if these cases were related to Gilenya. Contact your doctor with any questions or concerns.


• 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.


• Gilenya may interfere with certain lab tests, including peripheral blood lymphocyte counts. Be sure your doctor and lab personnel know you are taking Gilenya.


• Lab tests, including electrocardiogram (ECG), complete blood cell counts, blood pressure, lung function, liver function, and eye exams, may 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.


• Gilenya should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• 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; cough; diarrhea; headache; mild hair loss; weakness.

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); chest pain; confusion; dizziness; eye pain; new or worsening breathing problems (eg, shortness of breath); one-sided weakness; severe or persistent headache; slow or irregular heartbeat; slurred speech; symptoms of infection (eg, fever, chills, sore throat, severe or persistent cough, 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, decreased clearness of vision, 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.

See also: Gilenya side effects (in more detail)

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. Symptoms may include chest tightness or discomfort.

Proper storage of Gilenya:

Store Gilenya at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. 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 is a summary only. It does not contain all information about Gilenya. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Gilenya resources

• Gilenya Side Effects (in more detail)
• Gilenya Use in Pregnancy & Breastfeeding
• Gilenya Drug Interactions
• Gilenya Support Group
• 14 Reviews for Gilenya - Add your own review/rating

• Gilenya Prescribing Information (FDA)


• Gilenya Monograph (AHFS DI)


• Gilenya Advanced Consumer (Micromedex) - Includes Dosage Information


• Gilenya Consumer Overview

Compare Gilenya with other medications

• Multiple Sclerosis