Revised SPC: Gilenya (fingolimod) 0.5mg hard capsules -

Revised SPC: Gilenya (fingolimod) 0.5mg hard capsules
Information type: Drug prescribing
Source: Glenmark Pharmaceuticals Europe Ltd
Specialities: Neurological disorders
Summary
SPC now states progressive multifocal leukoencephalopathy (PML) has been reported with fingolimod. A baseline MRI should be done before treatment initiation and during routine MRI, check for PML lesions. If PML is suspected, MRI should be performed and treatment suspended.
UKMi comment
In Dec 2015, the European Medicines Agency (EMA) issued new recommendations to minimise the risk of PML in patients treated with fingolimod.
Related links: EMA advice