Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Enhertu

Enhertu 100 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11

HOS-144515 · Präparat HOS-099200

Dose interruptions due to adverse reactions occurred in 54.1% of patients treated with Enhertu 5.4 mg/kg in combination with pertuzumab. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia (15.5%), upper respiratory tract infection (12.3%), anaemia (7.2%), fatigue (7.2%), ILD (7.0%), hypokalaemia (6.3%), diarrhoea (5.8%), thrombocytopenia (5.3%), pneumonia (4.6%), leukopenia (3.9%), increased transaminases (3.7%), cough (2.6%), increased blood bilirubin (2.3%), decreased appetite (2.1%), pyrexia (2.1%) and vomiting (2.1%). Dose reductions occurred in 38.5% of patients treated with Enhertu 5.4 mg/kg in combination with pertuzumab. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue (11.6%), neutropenia (7.4%), nausea (6.5%), diarrhoea (6.0%), ILD (3.2%), thrombocytopenia (3.2%), vomiting (3.0%), increased transaminases (2.8%), decreased weight (2.3%) and febrile neutropenia (2.1%). The permanent discontinuation of any drug due to an adverse reaction occurred in 15.5% of patients treated with Enhertu 5.4 mg/kg in combination with pertuzumab. The most frequent adverse reaction (>2%) associated with permanent discontinuation was ILD (6.3%).

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