FAQs about Gilenya
The U.S. Food and Drug Administration (FDA) first approved Gilenya in 2010 to treat adults with relapsing forms of MS. These include clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The FDA then expanded the approval in 2018 to cover children as young as age 10.
Gilenya has not been well-studied in humans during pregnancy, but animal data suggest that it can harm a developing fetus. Patients who have the potential to become pregnant are recommended to use effective contraception while on Gilenya, and for at least two months after stopping treatment.
There is no known interaction between alcohol and Gilenya. However, since alcohol can interfere with some medications and disease symptoms, it is recommended that patients talk about this issue with their healthcare providers.
Some patients may see results as early as six months after starting treatment. In the FREEDOMS trials, which collectively compared Gilenya against a placebo in more than 2,000 patients with relapsing-remitting MS, a significantly smaller brain volume loss was evident with Gilenya as soon as six months after treatment start. However, each multiple sclerosis patient is unique and may have different manifestations of the disease; individuals also may respond differently to the medication. A discussion with their healthcare team can help patients understand how the medication may help in their specific case.
Changes in body weight were not reported in clinical trials as side effects of Gilenya, but some people who received the medication in the FREEDOMS trials experienced hair loss. Patients who experience unanticipated effects of treatment should discuss these with their care team.