Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Opdivo

OPDIVO 300 mg solution for injection OPDIVO 600 mg solution for injection · Abschnitt 4.8 · PDF-Seite 166

HOS-133454 · Präparat HOS-097426

Nivolumab in combination with chemotherapy In the pooled dataset of nivolumab 240 mg every 2 weeks or 360 mg every 3 weeks in combination with chemotherapy across tumour types (n = 1800), with a minimum follow-up ranging from 7.4 to 23.6 months, or following 3 cycles of treatment for resectable NSCLC, the most frequent adverse reactions (≥ 10%) were nausea (48%), fatigue (40%), peripheral neuropathy (33%), decreased appetite (31%), constipation (31%), diarrhoea (28%), vomiting (24%), rash (19%), abdominal pain (18%), stomatitis (18%), musculoskeletal pain (18%), pyrexia (16%), cough (13%), oedema (including peripheral oedema) (12%), and pruritus (11%). Incidences of Grade 3-5 adverse reactions were 69% for nivolumab in combination with chemotherapy, with 1.2% fatal adverse reactions attributed to nivolumab in combination with chemotherapy. Median duration of therapy was 6.14 months (95% CI: 5.78, 6.60) for nivolumab in combination with chemotherapy. For resectable NSCLC, ninety-three percent (93%) of patients received 3 cycles of nivolumab in combination with chemotherapy.

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