warning: Fingolimod (Gilenya): first reported case of progressive multifocal leukoencephalopathy

Fingolimod (Gilenya): first reported case of progressive multifocal leukoencephalopathy (PML) in a multiple sclerosis patient taking Fingolimod without previous treatment by natalizumab or other immunosuppressive medicines Dear Healthcare Professional, In agreement with European Medicines Agency (EMA) and the Health Productcs Regulatory Authority (HPRA), Novartis would like to inform you of a first case report of PML in a patient taking fingolimod for multiple sclerosis without previous treatment by natalizumab or other immunosuppressive medicines Summary • A case of PML was reported in February 2015 in a patient who had been taking fingolimod for more than 4 years. • This is the first case report of PML in a multiple sclerosis patient taking fingolimod who had not previously received natalizumab (Tysabri) or other immunosuppressive medicines. • PML was suspected on a routine brain MRI scan and confirmed by positive JC virus DNA in cerebrospinal fluid (CSF) using quantitative PCR. Fingolimod was stopped immediately and to date, the patient has not experienced any clinical signs or symptoms related to PML. • Prescribers are recommended to be vigilant for the risk of PML in patients treated with fingolimod. The treatment should be permanently discontinued in case of PML.