What is Gilenya - Fingolimod?
Gilenya is a medicine that contains the active substance fingolimod. It is available in the form of 0.5 mg capsules.
What is Gilenya - Fingolimod used for?
Gilenya is used to treat adult patients with highly active multiple sclerosis (MS). MS is a nerve disease characterized by "inflammation that destroys the protective sheath around nerve cells. Gilenya is used for the type of MS known as" relapsing-remitting "when the patient suffers from attacks (relapses) alternating with periods with decreased symptoms (remissions) The medicine is used when the disease has not responded to treatment with interferon beta (another type of medicine used for MS), or when the disease is severe and rapidly evolving.
The medicine can only be obtained with a prescription.
How is Gilenya used?
Gilenya treatment should be initiated and supervised by a physician experienced in multiple sclerosis. The recommended dose is one capsule taken orally once a day.
How does Gilenya - Fingolimod work?
In MS, the immune system does not function well and attacks parts of the central nervous system (the brain and spinal cord). The active substance in Gilenya, fingolimod, reduces the ability of T cells (a type of white blood cell involved in the immune system) to travel from the lymph nodes to the brain and spinal cord, thereby limiting the damage they do in MS. Fingolimod blocks the action of a T cell receptor, sphingosine 1-phosphate, which helps regulate the movement of these cells in the body.
How has Gilenya - Fingolimod been studied?
The effects of Gilenya were first tested in experimental models before being studied in humans.
Two main studies have been performed in MS patients treated with Gilenya in two doses (0.5 mg and 1.25 mg). In the first study Gilenya was compared to placebo for two years in 1,272 patients with relapsing-remitting multiple sclerosis. In the second study Gilenya was compared to treatment with beta interferon for one year in 1,292 patients. In both studies, the main evidence for efficacy was based on the number of relapses the patients experienced each year.
What benefit has Gilenya - Fingolimod shown during the studies?
Gilenya was more effective than placebo and interferon beta in reducing the number of relapses. The lowest dose was as effective as the highest. In the first study, the number of relapses per year among Gilenya-treated patients was about the half that seen in patients treated with placebo.In the second study, the number of relapses among patients treated with Gilenya was also about half that seen in patients treated with interferon beta.
What are the risks associated with Gilenya - Fingolimod?
The most frequent side effects with Gilenya (seen in more than 1 in 10 patients) are flu, headache, cough, diarrhea, back pain and an increase in the level of liver enzymes. For the full list of side effects reported with Gilenya, see the Package Leaflet.
Gilenya must not be used in people who are hypersensitive (allergic) to fingolimod or any of the other ingredients. Gilenya must not be used in patients who are at risk of infections related to a weakened immune system, who have a severe or long-term infection such as hepatitis, who have cancer (except a type of skin cancer called "basal cell carcinoma") or who have severe liver problems. Women should avoid becoming pregnant while taking Gilenya and for two months after stopping treatment.
Why has Gilenya - Fingolimod been approved?
The CHMP (Committee for Medicinal Products for Human Use) concluded that the efficacy of Gilenya has been demonstrated and also noted that the medicine has the advantage of taking it orally. However, due to its safety profile, the Committee concluded that Gilenya should only be used by patients who have a real need, i.e. when they have not responded to treatment with beta interferon or when their disease is severe and rapidly evolving. . The Committee therefore decided that Gilenya's benefits are greater than its risks and recommended that it be given marketing authorization.
What measures are being taken to ensure the safe use of Gilenya - Fingolimod?
The company that makes Gilenya must ensure that all doctors wishing to prescribe the medicine receive an information packet containing important safety information, including a checklist of the risks associated with Gilenya, and on the checks and monitoring to be performed on patients. it must also contain information on the registry that the company will create to collect data on children born to women undergoing treatment with Gilenya and a reminder with key safety information for patients.
Other information about Gilenya - Fingolimod
On 17 March 2011, the European Commission granted Novartis Europharm Ltd a "Marketing Authorization" for Gilenya, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For more information on Gilenya therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 02-2011.
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