Nebenwirkungen · Braftovi
Braftovi 50 mg hard capsules Braftovi 75 mg hard capsules · Abschnitt 4.8 · PDF-Seite 20
HOS-140109 · Präparat HOS-098444
Colorectal cancer Encorafenib and cetuximab combination In patients treated with encorafenib 300 mg in combination with cetuximab, dermatitis acneiform occurred in 33.3% (72/216) of patients and was mostly Grade 1 (25.5% (55/216) of patients), or 2 (6.9% (15/216) of patients). Dose reduction or interruption was reported in 2.3 % (5/216) of patients. No treatment discontinuation was reported. Dermatitis acneiform was generally reversible. Encorafenib with cetuximab and FOLFOX combination In the pooled EC+FOLFOX population, dermatitis acneiform occurred in 22.4% (58/259) of patients. Most of the events were Grade 1 or 2, and 0.8% (2/259) were Grade 3 events. Dose reduction or interruption was reported in 1.9 % (5/259) of patients. No treatment discontinuation was reported.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-07-01T15:53:00Z · SHA-256 47125c84bb304df39202c4dc14aefc287bbf903ef279d3e55fe42dc6648e375c · Passage 5bc67f805a8320c2becd679c490719f994ad1e07945d4f8611835f2b5af7b4e3 · Zeichen 26036–26817 im Abschnitt