Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Opdivo

OPDIVO 10 mg/mL concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 41

HOS-133409 · Präparat HOS-097426

Elevated liver enzymes when nivolumab is combined with cabozantinib in RCC In a clinical study of previously untreated patients with RCC receiving nivolumab in combination with cabozantinib, a higher incidence of Grades 3 and 4 ALT increased (10.1%) and AST increased (8.2%) were observed relative to nivolumab monotherapy in patients with advanced RCC. In patients with Grade ≥ 2 increased ALT or AST (n=85): median time to onset was 10.1 weeks (range: 2.0 to 106.6 weeks), 26% received corticosteroids for median duration of 1.4 weeks (range: 0.9 to 75.3 weeks), and resolution to Grades 0-1 occurred in 91% with median time to resolution of 2.3 weeks (range: 0.4 to 108.1+ weeks). Among the 45 patients with Grade ≥ 2 increased ALT or AST who were rechallenged with either nivolumab (n=10) or cabozantinib (n=10) administered as a single agent or with both (n=25), recurrence of Grade ≥ 2 increased ALT or AST was observed in 3 patients receiving nivolumab, 4 patients receiving cabozantinib, and 8 patients receiving both nivolumab and cabozantinib.

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