An oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults.  Used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability.

Related Information

• FDA Drug Safety Communication: FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs
• FDA Drug Safety Communication: FDA investigating rare brain infection in patient taking Gilenya (fingolimod)
• FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)
• FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod)
• FDA investiga infección cerebral poco común en paciente que tomó Gilenya (fingolimod)

Labeling and Regulatory History from Drugs@FDA

• Fingolimod (marketed as Gilenya) Prescribing and Labeling Information