Nebenwirkungen · Enhertu
Enhertu 100 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 14–15
HOS-144525 · Präparat HOS-099200
14 In patients treated with Enhertu 6.4 mg/kg in clinical studies across multiple tumour types (n = 1133), ILD, pneumonitis, organising pneumonia, and acute interstitial pneumonitis were reported by the investigator in 16.9% of patients. ILD/pneumonitis was confirmed by adjudication in 15.4% of patients, leading to drug discontinuation in 10.1% of patients and drug interruption in 4.7% of patients. Most ILD/pneumonitis cases were Grade 1 (4.1%) and Grade 2 (8.6%). Grade 3 cases occurred in 1.1% and one Grade 4 case occurred. Grade 5 (fatal) events occurred in 1.6% of patients. Median time to first onset was 4.1 months (range: -0.5 to 21.0), including two patients adjudicated as having pre- existing ILD. Recovery was not reported for 37.4% of patients with adjudicated ILD/pneumonitis at a median follow up of 251 days (see sections 4.2 and 4.4).
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 2026-10-20T16:27:00Z · SHA-256 3c4c744afc1ef29bbcad254e39bd7fd8b4be34bb4ddecf254258c2ab2c9863c8 · Passage 8a9895398035bef99ae18c984fd72289f62808bf1e5a33f24f3211fc71eb54d0 · Zeichen 24439–25295 im Abschnitt