Generic Name: fingolimod (fin GOE li mod)
Brand Names: Gilenya

What is Gilenya?

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. This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

Important information

You should not use Gilenya if you are allergic to fingolimod, or 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 (including "mini-stroke"), chest pain (unstable angina), or other serious heart problem.

Before you take Gilenya, tell your doctor if you have an infection, a very slow heart rate, low blood pressure or a history of fainting, high blood pressure, diabetes, liver or kidney disease, asthma or other breathing disorder, congestive heart failure, heart rhythm disorder, a serious heart condition, or if you have ever had an eye condition called uveitis.

Slideshow: Flashback: FDA Drug Approvals 2013

Also tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax).

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 of Gilenya. 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. Fingolimod can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood tests or eye exams.

Tell your doctor if you use any heart or blood pressure medications. Do not receive a "live" vaccine while using Gilenya.

Do not stop taking this medicine without first talking to your doctor. 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.

Before taking this medicine

You should not use Gilenya if you are allergic to fingolimod, or if you have certain serious heart conditions, especially:

  • severe heart failure (that required you to be in the hospital);

  • "AV block" or sick sinus syndrome (unless you have a pacemaker);

  • a recent (within the past 6 months) heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other serious heart problem; or

  • if you take any of these heart rhythm medications - amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), dronedarone (Multaq), ibutilide (Corvert), mexiletine (Mexitil), procainamide (Procan, Pronestyl), propafenone, (Rythmol), quinidine (Quin-G), or sotalol (Betapace).

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:

  • an active or chronic infection;

  • a very slow heart rate (fewer than 55 beats per minute);

  • low blood pressure or a history of fainting;

  • high blood pressure, heart disease, congestive heart failure;

  • a history of Long QT syndrome;

  • diabetes;

  • liver or kidney disease;

  • asthma or other breathing disorder; or

  • history of an eye condition called uveitis.

FDA pregnancy category C. It is not known whether Gilenya will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. Use effective birth control while you are using this medication and for at least 2 months after your treatment ends.

See also: Pregnancy and breastfeeding warnings (in more detail)

Fingolimod can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Gilenya.

Do not give this medication to anyone under 18 years old without medical advice.

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 of Gilenya.

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 Gilenya 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 any of these 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:

  • slow heart rate, dizziness, feeling very weak or tired;

  • fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat;

  • chest tightness, trouble breathing;

  • headache, confusion, change in mental status, vision loss, seizure (convulsions);

  • 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).

  • sudden numbness or weakness, sudden severe headache, seizure (convulsions); or

  • 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:

  • headache, back pain;

  • diarrhea;

  • flu symptoms; or

  • 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?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Gilenya, especially:

  • anagrelide, droperidol, ketoconazole, methadone, ondansetron;

  • an antibiotic - azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine;

  • cancer medicine - arsenic trioxide, vandetanib;

  • an antidepressant - citalopram, escitalopram;

  • anti-malaria medication - chloroquine, halofantrine;

  • drugs that weaken the immune system - cancer medicine, steroids, or medicines to treat an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;

  • heart or blood pressure medicine - amlodipine, atenolol, carvedilol, diltiazem, metoprolol, nifedipine, propranolol, verapamil, and others;

  • heart rhythm medicine - amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol; or

  • medicine to treat a psychiatric disorder - chlorpromazine, haloperidol, pimozide, thioridazine.

This list is not complete. Other drugs may interact with fingolimod, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Gilenya.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 4.01. Revision Date: 2014-09-04, 2:19:26 PM.

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