What is Gilenya - Fingolimod?
Gilenya is a medicine that contains the active substance fingolimod. It is available as 0.5 mg capsules.
What is Gilenya - Fingolimod used for?
Gilenya is used to treat adult patients with high activity 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 - Fingolimod used?
Treatment with Gilenya should be started and supervised by a doctor 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 work well and attacks parts of the central nervous system (the brain and spinal cord). The active ingredient in Gilenya, fingolimod, reduces the ability of T cells (a type of white blood cell involved in the immune system) to move from the lymph nodes to the brain and spinal cord, thus limiting the damage they cause in MS cases. Fingolimod blocks the action of a T cell receptor, sphingosine 1-phosphate, which contributes to the regulation of the displacement of these cells in the body.
What studies have been carried out on Gilenya - Fingolimod?
The effects of Gilenya were first tested in experimental models before being studied in humans.
Two main studies were carried out on patients with MS and 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 interferon beta treatment for one year in 1 292 patients. In both studies the main evidence of efficacy was based on the number of relapses seen by patients 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 one. In the first study, the number of relapses per year among patients treated with Gilenya was about half that seen in patients treated with placebo. In the second study, too, the number of relapses among patients treated with Gilenya was about half as compared to that seen in patients treated with interferon beta.
What are the risks associated with Gilenya - Fingolimod?
The most frequent side effects of Gilenya (seen in more than 1 patient in 10) are flu, headache, cough, diarrhea, back pain and increased liver enzyme level. For the full list of all side effects reported with Gilenya, see the Package Leaflet.
Gilenya should not be used in people who may be hypersensitive (allergic) to fingolimod or any of the other ingredients. Gilenya should not be used in patients who risk infections related to the weakening of the immune system, suffering from a severe or long-term infection such as hepatitis, cancer (except a type of skin neoplasm called "basal cell carcinoma") or with severe liver problems. Women should avoid pregnancy while taking Gilenya and for two months after the end of 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 further noted that the medicine has the advantage of taking it by mouth. However, due to its safety profile, the committee concluded that Gilenya should only be used by patients who have a real need, ie when they have not responded to treatment with interferon beta 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 Gilenya-based company must ensure that all physicians who intend to prescribe the medicine receive an information package containing important safety information, including a checklist of the risks associated with Gilenya, and on the checks and monitoring to be performed on the patients. The package must also contain information on the register that the company will create to collect data on children born to women treated with Gilenya and a reminder with the main information on patient safety.
More information on Gilenya - Fingolimod
On 17 March 2011, the European Commission issued a marketing authorization valid throughout the European Union for Gilenya to Novartis Europharm Ltd. The marketing authorization is valid for five years, after which it can be renewed.
For more information on Gilenya therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 02-2011.
