Nebenwirkungen · Tecfidera
Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules · Abschnitt 4.8 · PDF-Seite 11
HOS-127607 · Präparat HOS-096433
In clinical studies (both controlled and uncontrolled), 41% of patients treated with Tecfidera had lymphopenia (defined in these studies as < 0.91 × 109/L). Mild lymphopenia (counts ≥ 0.8 × 109/L to < 0.91 × 109/L) was observed in 28% of patients; moderate lymphopenia (counts ≥ 0.5 × 109/L to < 0.8 × 109/L) persisting for at least six months was observed in 11% of patients; severe lymphopenia (counts < 0.5 × 109/L) persisting for at least six months was observed in 2% of patients. In the group with severe lymphopenia, the majority of lymphocyte counts remained < 0.5 × 109/L with continued therapy.
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