Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Hefiya

Hefiya 20 mg solution for injection in pre-filled syringe Hefiya 40 mg solution for injection in pre-filled syringe Hefiya 40 mg solution for injection in pre-filled pen Hefiya 80 mg solution for injection in pre-filled syringe Hefiya 80 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 82

HOS-142623 · Präparat HOS-098832

In controlled Phase 3 studies of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1 % of adalimumab-treated patients and 1.3 % of control-treated patients. Most ALT elevations occurred with concomitant methotrexate use. No ALT elevations ≥ 3 x ULN occurred in the Phase 3 study of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to < 4 years.

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