Gilenya (fingolimod)

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Gilenya (fingolimod) is a type of immunomodulatory drug called a sphingosine 1-phosphate receptor modulator. Made by Novartis, Gilenya is the first member of this class of drugs to be used as a disease-modifying treatment for MS and is available for oral administration as a capsule. Gilenya is indicated (approved for use) in the treatment of relapsing forms of MS to reduce the frequency of exacerbations and delay the progression of disability.

 

How does Gilenya work?

Gilenya is an immunomodulator which works by blocking a certain type of white blood cell called lymphocytes (lymphocytes play an important role in our body’s immune response) from leaving the lymph nodes, where they originate. This decreases the number of lymphocytes in the blood stream throughout the body. Although we don’t know exactly how Gilenya works to delay progression of disability and decrease the frequency of exacerbations in MS, it is thought that Gilenya may reduce the ability of lymphocytes to migrate or move into the CNS. Because lymphocytes play a role in inflammation that causes demyelination, a decrease of lymphocytes in the CNS may inhibit the abnormal immune response that is involved in MS.

 

How is Gilenya taken?

Gilenya is an oral pill taken by mouth once daily with a recommended dose of 0.5 mg. It can be taken with or without food. Because Gilenya can cause bradycardia (a decrease in heart rate), the first time you take the drug you will be monitored for about 6 hours. The symptoms of bradycardia include dizziness, tiredness, and feeling like your heart is beating slowly or skipping beats. While being monitored, your pulse and blood pressure will be measured and an electrocardiogram will be taken to make sure that Gilenya is not having an adverse effect on your heart function.

You should not stop taking Gilenya without first talking to your doctor. If you start taking Gilenya again after stopping for 2 or more weeks, you must restart Gilenya under supervision of your doctor.

 

Are there people who should not take Gilenya?

Persons who have had a heart attack, unstable angina, a stroke or warning stroke, or certain kinds of heart failure within the last 6 months, should not take Gilenya. Additionally, persons who have certain types of irregular or abnormal heart rhythms (called arrhythmia), including a problem called prolonged QT, or who are taking a medication to correct heart rhythm, should not take Gilenya.

Before starting Gilenya, you should tell your doctor if you have any of the heart problems described above. You should also tell your doctor if you have any of the following risk factors:

  • A history of repeated fainting, known as syncope
  • Diabetes
  • Eye problems, especially a type of inflammation of the eye called uveitis
  • Fever or infection, or the inability to fight infections
  • Have ever had chicken pox or the vaccine for chicken pox (if you haven’t had the vaccine, you may need to be vaccinated before you can start Gilenya)
  • Liver problems
  • Breathing problems, including those occurring during sleep
  • High blood pressure, or hypertension
  • Pregnant or planning to become pregnant as Gilenya may cause harm to an unborn baby
  • Breast feeding, as it is not known whether Gilenya can pass into breast milk and  harm your baby

You should also tell your doctor about all medications, prescription and nonprescription, you are taking, including supplements, vitamins, and herbal preparations.

 

What evidence do we have that Gilenya works?

The effectiveness of Gilenya in people with MS has been tested in two large randomized, double-blind, controlled studies. In a randomized double-blind, placebo-controlled study, some participants are given the treatment being tested while others are given fake treatment (placebo).  Neither the researchers nor the participants know which is being taken until the study ends (hence, “double-blind”). Assignment of participants to treatment or placebo is done randomly (hence, “randomized”). Randomized, double-blind, placebo-controlled studies are considered the best way to evaluate a medicine. Both studies included people with relapsing remitting MS (RRMS) who had had at least 2 relapses within the 2 years before the study started or 1 relapse in the year before the study started with evidence of a certain level of disability as measured by the Expanded Disability Status Scale (EDSS).

In the first study, a 2-year placebo-controlled study called FREEDOMS, Gilenya was compared with placebo. People who participated in this study had received no interferon beta medication or glatiramer acetate (Copaxone) for at least 3 months before the study and had not received natalizumab (Tysabri) for at least 6 months before the start of the study. Gilenya resulted in a significantly lower annual rate of relapses (54% lower) and a significant delay in progression of disability (30% lower) compared with placebo. People who received Gilenya also had fewer new or newly enlarged brain lesions as seen by magnetic resonance imaging (MRI) compared with placebo.

In the second study, a 1-year active-controlled study called TRANSFORMS, Gilenya was compared with  the interferon beta medication Avonex, instead of placebo. Gilenya resulted in significantly fewer relapses than Avonex (a 52% reduction). However, there was no difference between Gilenya and Avonex in how well they slowed the progression of disability. Gilenya resulted in a significantly greater reduction in disease activity as seen by MRI, including reductions in new and newly enlarging brain lesions and brain lesion activity, compared with Avonex.

 

Is there a generic version of Gilenya?

At this time, there is no generic version of Gilenya.

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