Nebenwirkungen · Enhertu
Enhertu 100 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 15
HOS-144526 · Präparat HOS-099200
Enhertu 5.4 mg/kg in combination with pertuzumab In patients treated with Enhertu 5.4 mg/kg in combination with pertuzumab (n = 431), ILD, pneumonitis, organising pneumonia and acute interstitial pneumonitis were reported by the investigator in 16.7% of patients. ILD was confirmed by adjudication in 13.0% of patients, leading to drug discontinuation in 6.3% of patients and drug interruption in 7.0% of patients. Most ILD cases were Grade 1 (3.9%) and Grade 2 (8.4%). Grade 3 cases occurred in 0.2%. No Grade 4 case occurred. Grade 5 (fatal) events occurred in 0.5% of patients. Median time to first onset was 8.1 months (range: 0.6 to 33.8). Recovery was not reported for 26.8% of patients with adjudicated ILD/pneumonitis at a median follow up of 336 days (see sections 4.2 and 4.4).
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