Gilenya (fingolimod) is an immunosuppressant. It works by keeping immune cells trapped in your lymph nodes so they can"t reach the central nervous system (brain and spinal cord).
Gilenya is used to treat relapsing multiple sclerosis (MS) in adults.
Gilenya will not cure MS, it will only decrease the frequency of relapse symptoms.
Important information
You should not use Gilenya if you have certain serious heart conditions, especially severe heart failure, "AV block," sick sinus syndrome (unless you have a pacemaker), if you take certain heart rhythm medicines, or if you have recently had a heart attack, stroke, chest pain, or other serious heart problem.
Before taking this medicine
You should not use Gilenya if you are allergic to fingolimod, or if you have certain serious heart conditions, especially:
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severe heart failure (that required you to be in the hospital);
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"AV block" or sick sinus syndrome (unless you have a pacemaker);
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a recent (within the past 6 months) heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other serious heart problem; or
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if you take any of these heart rhythm medications--amiodarone, disopyramide, dofetilide, flecainide, dronedarone, ibutilide, mexiletine, procainamide, propafenone, quinidine, or sotalol.
Before you take Gilenya, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking fingolimod.
To make sure Gilenya is safe for you, tell your doctor if you have:
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an active or chronic infection;
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a very slow heart rate (fewer than 55 beats per minute);
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low blood pressure or a history of fainting;
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high blood pressure, heart disease, congestive heart failure;
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a history of Long QT syndrome;
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diabetes;
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liver or kidney disease;
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asthma, sleep apnea, or other breathing disorder;
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history of an eye condition called uveitis; or
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if you also take ketoconazole.
It is not known whether Gilenya will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control while you are using this medication and for at least 2 months after your treatment ends.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Gilenya on the baby.
Fingolimod can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using fingolimod.
Gilenya is not approved for use by anyone younger than 18 years old.
How should I take Gilenya?
Take Gilenya exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Before you start taking Gilenya, your blood will need to be tested. Your heart function will also need to be checked using an electrocardiograph or ECG (sometimes called an EKG).
You will receive your first dose of Gilenya in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects. Your blood pressure and heart rate will be constantly monitored for at least 6 hours after your first dose.
You may take Gilenya with or without food.
Gilenya can increase you risk of infection for up to 2 months after you stop taking the medicine. Call your doctor if you develop any signs of a new infection.
To be sure this medication is not causing harmful effects, your blood cells, blood pressure, liver function, and lung function will need to be tested often. You may also need to eye exams. Gilenya can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood tests or eye exams.
You should not stop using this medicine suddenly. Stopping suddenly may make your condition worse.
If you stop taking Gilenya for 2 weeks or longer, do not start taking it again without asking your doctor. You will need to restart the medication in a hospital setting under observation.
Store in the original package at room temperature away from moisture and heat.
Gilenya dosing information
Usual Adult Dose for Multiple Sclerosis:
0.5 mg orally once daily
Comments: Monitor with first dose (see WARNINGS section).
Use: For the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include chest tightness.
What should I avoid while taking Gilenya?
Do not receive a "live" vaccine while using Gilenya. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Gilenya side effects
Get emergency medical help if you have signs of an allergic reaction to Gilenya: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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slow heart rate, dizziness, feeling very weak or tired;
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fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat, cold sores, sores on your genital or anal area;
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chest tightness, trouble breathing;
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sudden headache, confusion, change in mental status, vision loss, seizure (convulsions);
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vision problems, blurred vision, eye pain, increased sensitivity to light, or having a blind spot or shadows in the center of your vision (vision problems may occur 3 to 4 months after you start taking Gilenya);
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sudden numbness or weakness, sudden severe headache, seizure (convulsions); or
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liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Gilenya side effects may include:
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headache, back pain;
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stomach pain, diarrhea;
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pain in your arms or legs;
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cough, stuffy nose, flu symptoms; or
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abnormal liver function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Gilenya?
Gilenya can cause a serious heart problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Gilenya.
Other drugs may interact with fingolimod, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
