Nebenwirkungen · Benlysta
Benlysta 200 mg solution for injection in pre-filled syringe. · Abschnitt 4.8 · PDF-Seite 34
HOS-123964 · Präparat HOS-095751
In a randomised, double-blind, 52-week, post-marketing safety SLE study (BEL115467) which assessed mortality and specific adverse events in adults, serious infections occurred in 3.7 % of patients receiving Benlysta (10 mg/kg body weight intravenously) vs. 4.1 % of patients receiving placebo. However, fatal infections (e.g. pneumonia and sepsis) occurred in 0.45 % (9/2002) of Benlysta-treated patients vs. 0.15 % (3/2001) of patients receiving placebo, while the incidence of all-cause mortality was 0.50 % (10/2002) vs. 0.40 % (8/2001), respectively. Most fatal infections were observed during the first 20 weeks of treatment with Benlysta.
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