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.
Gilenya may also be used for purposes not listed in this medication guide.
Important information about Gilenya
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.
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. 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.
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 Gilenya 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 Gilenya
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 Gilenya.
To make sure you can safely take Gilenya, tell your doctor if you have any of these other conditions:
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;
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 medication. Use effective birth control while you are using Gilenya and for at least 2 months after your treatment ends. 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.
See also: Gilenya pregnancy and breastfeeding warnings (in more detail)
How should I take Gilenya?
Take Gilenya exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
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). This machine measures electrical activity of the heart.
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. Do not stop taking this medication 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.
Store Gilenya in original package at room temperature away from moisture and heat.
See also: Gilenya dosage (in more detail)
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), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu 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 a serious side effect such as:
slow heart rate, dizziness, feeling very weak or tired;
chest pain, pounding heartbeats or fluttering in your chest;
sudden numbness or weakness, severe headache, problems with speech or walking;
wheezing, chest tightness, trouble breathing, cough with yellow or green mucus;
fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat;
swelling, warmth, redness, oozing, itchy rash, or other signs of skin infection;
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
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).
Less serious Gilenya side effects may include:
headache, tired feeling;
stuffy nose, sinus pain, or cough.
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: Gilenya side effects (in more detail)
What other drugs will affect Gilenya?Tell your doctor if you use any heart or blood pressure medications, such as:
a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or
a calcium channel blocker such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others.
Tell your doctor about all other medicines you use, especially:
arsenic trioxide (Trisenox);
an antibiotic such as azithromycin (Zithromax, Zmax, Z-Pack), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);
an antidepressant such as amitriptylline (Elavil, Vanatrip, Limbitrol), citalopram (Celexa), clomipramine (Anafranil), or desipramine (Norpramin);
anti-malaria medications such as chloroquine (Aralen), halofantrine (Halfan), or mefloquine (Lariam);
heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), flecainide (Tambocor), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);
medicine to prevent or treat nausea and vomiting such as dolasetron (Anzemet), droperidol (Inapsine), or ondansetron (Zofran);
medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);
migraine headache medicine such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig);
narcotic medication such as methadone (Methadose, Diskets, Dolophine); or
drugs that weaken the immune system, such as cancer medicine, steroids, medicines to prevent rejection of a transplanted organ, and other drugs to treat MS.
This list is not complete and other drugs may interact with Gilenya. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Gilenya resources
Compare Gilenya with other medications
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.
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