Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Opdivo

OPDIVO 300 mg solution for injection OPDIVO 600 mg solution for injection · Abschnitt 4.8 · PDF-Seite 173

HOS-133477 · Präparat HOS-097426

In patients treated with nivolumab in combination with ipilimumab (with or without chemotherapy), the incidence of liver function test abnormalities was 21.2% (556/2626). Grade 2, Grade 3, and Grade 4 cases were reported in 5.0% (132/2626), 8.3% (218/2626), and 1.3% (34/2626) of patients, respectively. Seven patients (0.3%) had a fatal outcome. Median time to onset was 1.5 months (range: 0.0-36.6). Resolution occurred in 482 patients (87.0%) with a median time to resolution of 5.9 weeks (range: 0.1-175.9+). Among patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg for melanoma, the incidence of liver function test abnormalities was 30.1% including Grade 2 (6.9%), Grade 3 (15.8%), and Grade 4 (1.8%). Among patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg for HCC, the incidence of liver function test abnormalities was 34.3% including Grade 2 (8.4%), Grade 3 (14.2%), and Grade 4 (2.7%).

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