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Fingolimod (Gilenya)- patient information



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Brand Name


What it is

A disease-modifying oral agent that is indicated to reduce the frequency of MS exacerbations and to delay the progression of physical disability in patients with relapsing forms of MS.  


What it does

Gilenya is a disease-modifying drug used as monotherapy to reduce exacerbations and accumulation of disability in relapsing forms of MS. Two major clinical trials were done to assess the efficacy and safety of the drug. One tested Gilenya versus a placebo, the other tested Gilenya versus interferon. One trial demonstrated a significant delay in disability progression and both trials showed a significantly lower relapse rate.


How it works

The mechanism of Gilenya is not fully understood.  It binds to receptors in the body that block progression of lymphocytes (white blood cells) into the blood and may reduce the movement of lymphocytes into the central nervous system (brain and spinal cord).  Lymphocytes are part of the auto-immune response in MS; they play a role in inflammation and the demyelination (removal of protective covering) of axons. 


How it’s taken


Gilenya 0.5 mg orally once daily.


-Take the tablet whole. Do not break, crush, chew, or dissolve before swallowing as this may increase the risk for side effects.

-May be taken with or without food.

-Do not discontinue Gilenya without first talking to your physician. 

-If you miss a dose, take when you remember, but if it is too close to the next dose DO NOT DOUBLE UP.  You will be monitored for six hours after the first dose for signs of bradycardia (slow heart rate).  

-If you are taking an anti-arrhythmic medication (including calcium channel blockers and beta-blockers) or have other cardiac risk factors such as congestive heart failure an EKG will be obtained prior to beginning therapy.

-If you have not had chickenpox before or a varicella zoster virus (VZV) vaccine, you may be tested for antibodies to VZV.  If you do not have antibodies to VZV, you may be asked to receive the vaccination prior to starting therapy. 

-A complete blood count, bilirubin, and liver function tests will be obtained before initiation of therapy.

-An eye exam will be administered before initiation of therapy and 3-4 months into therapy. 

Possible Side Effects



-Influenza (flu)


-Back pain


-Increase in liver enzymes




-AV block and bradyarrhythmia

-Macular Edema




All side effects should be reported to your physician. You may report side effects to the FDA at 1-800-FDA-1088.



-If discontinued for more than two weeks, re-initiation of therapy will require another six-hour monitoring period after the re-initiation dose. 

-Certain vaccines should be avoided while on Gilenya and two months following discontinuation of therapy.

-Gilenya greatly increases your risk of infections.  Report any signs of infection (fever, sore throat, cough, etc) to your healthcare provider. 

-Gilenya may cause macular edema; a serious condition of the eye.  Please notify your physician of any changes in vision.  If you are diabetic or have a history of uveitis, your risk is increased. 

-Inform your physician if you have any shortness of breath.

-Gilenya may affect your liver enzymes.  Inform your doctor if you have any nausea, vomiting, stomach pain, weight loss, yellowness of eyes, or dark urine. 

-Do not change the dose or dosing schedule without speaking with your physician.

Animal studies of Gilenya  have demonstrated harm to the fetus. Effective birth control is recommended while taking Gilenya and two months after discontinuing.

-Gilenya remains in your system two months after discontinuation.  Lymphocytes may continue to be low during these two months. 

-Notify your physician and pharmacist before starting any new prescription medications, over the counter medications or herbal supplements. Certain heart medications and anti-fungal drugs may strongly interact with Gilenya and need to be monitored. 

-Your progress with this drug will need to be monitored. It is important to keep all scheduled appointments.


Pregnancy Risk

-Gilenya is classifed as pregnancy risk category C, which means there are no adequate and well-controlled studies in pregnant women. Animal studies demonstrated fetal toxicity. Women taking this medication should practice adequate birth control.

-Gilenya should be stopped for at least 2 months prior to conceiving.


When to contact your healthcare provider

-If you become pregnant

-If you are experiencing or have experienced:

Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.

Any signs of infection (fever, sore throat, cough, etc)

Changes in vision

Shortness of breath

Nausea, vomiting, stomach pain, weight loss, yellowness of eyes, dark urine


Who to contact

For problems or concerns please call the MS Center at 617-525-6550 Monday through Friday 9am –5:00pm. During off-hours, please call the on-call doctor at 617-732-5656 then beeper #11378.

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