Nebenwirkungen · Benlysta
Benlysta 200 mg solution for injection in pre-filled pen. · Abschnitt 4.8 · PDF-Seite 10
HOS-123910 · Präparat HOS-095751
Infections: The overall incidence of infections in intravenous and subcutaneous pre-registration SLE studies was 63 % in both groups receiving Benlysta or placebo. Infections occurring in at least 3 % of patients receiving Benlysta and at least 1 % more frequently than patients receiving placebo were viral upper respiratory tract infection, bronchitis, and urinary tract infection bacterial. Serious infections occurred in 5 % of patients in both groups receiving Benlysta or placebo; serious opportunistic infections accounted for 0.4 % and 0 % of these, respectively. Infections leading to discontinuation of treatment occurred in 0.7 % of patients receiving Benlysta and 1.5 % of patients receiving placebo. Some infections were severe or fatal.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-08T14:51:00Z · SHA-256 c5a3f583695e2640a8d21bbd8da1102adfb181d1d2a9c5afe0028436c8fd2402 · Passage e9404feb0646afc6c4de85d9a46f6e340a81f934d280caf8b814bde80cb9cfb4 · Zeichen 7336–8086 im Abschnitt