UK Medicines Information
European Medicines Agency (EMA) issues updated recommendations to minimise risk of progressive multifocal leukoencephalopathy (PML) with dimethyl fumarate (Tecfidera)
Information type:
Safety alerts
Source:
European Medicines Agency
Specialities:
Infection and infectious diseases | Neurological disorders
Summary
EMA recommends complete blood count before starting treatment and every 3 months during treatment. A baseline MRI should be available (usually within 3 months) as a reference. If lymphocytes drop to very low levels for > 6 months, doctors should consider stopping Tecfidera.
UKMi comment
Further information can be found in the Biogen letter
Related links:
Biogen letter