Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Kadcyla

Kadcyla 100 mg powder for concentrate for solution for infusion Kadcyla 160 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 13

HOS-125652 · Präparat HOS-096111

Haemorrhage Haemorrhagic events were reported in 34.8% of patients in MBC clinical studies with trastuzumab emtansine and the incidence of severe haemorrhagic events (Grade ≥ 3) occurred in 2.2%. Haemorrhagic events were reported in 29.2% of patients with EBC and the incidence of severe haemorrhagic events (Grade ≥ 3) was 0.4%, including one Grade 5 event. In some of the observed cases the patients had thrombocytopenia, or were also receiving anti-coagulant therapy or antiplatelet therapy; in others there were no known additional risk factors. Cases of bleeding events with a fatal outcome have been observed in both MBC and EBC.

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