Nebenwirkungen · Tecfidera
Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules · Abschnitt 4.8 · PDF-Seite 11
HOS-127608 · Präparat HOS-096433
In addition, in an uncontrolled, prospective, post-marketing study, at week 48 of treatment with Tecfidera (n=185), CD4+ T cells were moderately (counts ≥ 0.2 × 109/L to < 0.4 × 109/L) or severely (<0.2 × 109/L) decreased in up to 37% or 6% of patients, respectively, while CD8+ T cells were more frequently reduced with up to 59% of patients at counts < 0.2 × 109/L and 25% of patients at counts < 0.1 × 109/L. In controlled and uncontrolled clinical studies, patients who discontinued Tecfidera therapy with lymphocyte counts below the LLN were monitored for recovery of lymphocyte count to the LLN (see section 5.1).
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