Nebenwirkungen · Braftovi
Braftovi 50 mg hard capsules Braftovi 75 mg hard capsules · Abschnitt 4.8 · PDF-Seite 13
HOS-140072 · Präparat HOS-098444
The safety of encorafenib (300 mg orally once daily) in combination with cetuximab and FOLFOX was evaluated in 259 patients with BRAF V600E-mutant metastatic colorectal cancer, based on the study C4221015 – BREAKWATER (hereafter referred to as the pooled EC+FOLFOX population, i.e all patients who received encorafenib and cetuximab (EC)+FOLFOX in the different portions of the study). The most common ADRs (>25%) reported in this population were: neuropathy peripheral, neutropenia, nausea, fatigue, anaemia, diarrhoea, vomiting, decreased appetite, rash, thrombocytopenia, abdominal pain, haemorrhage, arthralgia/musculoskeletal pain, pyrexia, constipation, mucosal inflammation and infection. The rate of all study drug discontinuation due to any adverse reaction was 3.5 % in patients treated with encorafenib 300 mg in combination with cetuximab and FOLFOX.
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