Nebenwirkungen · Hemlibra
Hemlibra 30 mg/mL solution for injection Hemlibra 150 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 10
HOS-138552 · Präparat HOS-098208
The following adverse drug reactions (ADRs) are based on data from post-marketing surveillance and pooled data from five phase III clinical studies (adult and adolescent studies [BH29884 - HAVEN 1, BH30071 – HAVEN 3, and BO39182 – HAVEN 4], an all-age group study [BO41423 – HAVEN 6], and a paediatric study [BH29992 - HAVEN 2]), in which a total of 444 patients with haemophilia A received at least one dose of Hemlibra as routine prophylaxis (see section 5.1). Three hundred and seven (69.1 %) of the clinical study participants were adults (of which two were female), 61 (13.7 %) were adolescents (≥ 12 to < 18 years), 71 (16.0 %) were children (≥ 2 to < 12 years) and five (1.1 %) were infants and toddlers (1 month to < 2 years). The median duration of exposure across the studies was 32 weeks (range: 0.1 to 94.3 weeks).
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Version 2025-09-10T14:44:00Z · SHA-256 a8b20be3c4cbbb534d4c89f4bc9fce14de5f500ee77b5005f9098554ba0096ef · Passage 626fa301af7ebdd9ab7046ce09ebca1884c65934c53107c4882d5ea98ba01c8f · Zeichen 880–1706 im Abschnitt