Nebenwirkungen · Tecfidera
Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules · Abschnitt 4.8 · PDF-Seite 11
HOS-127610 · Präparat HOS-096433
Cases of infections with John Cunningham virus (JCV) causing PML have been reported with Tecfidera (see section 4.4). PML may be fatal or result in severe disability. In one of the clinical trials, 1 patient taking Tecfidera developed PML in the setting of prolonged severe lymphopenia (lymphocyte counts predominantly < 0.5 × 109/L for 3.5 years), with a fatal outcome. In the post- marketing setting, PML has also occurred in the presence of moderate and mild lymphopenia (> 0.5 × 109/L to < LLN, as defined by local laboratory reference range).
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