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Direct Healthcare Professional Communication (DHPC) on Tecfidera® (dimethyl fumarate): updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia
2020.11.09
Active substance: dimethyl fumarate
Biogen Netherlands B.V. would like to inform you in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) that cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia (lymphocyte count ≥ 0.8 ×109/L and below the lower limit of normal) have been reported in patients treated with Tecfidera; previously, PML had been confirmed only in the setting of moderate to severe lymphopenia.
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