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 13–14

HOS-125656 · Präparat HOS-096111

13 Infusion-related reactions Infusion-related reactions are characterised by one or more of the following symptoms: flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm and tachycardia. Infusion-related reactions were reported in 4.0% of patients in MBC clinical studies with trastuzumab emtansine, with six Grade 3 and no Grade 4 events reported. Infusion-related reactions were reported in 1.6% of patients with EBC, with no Grade 3 or 4 events reported. Infusion-related reactions resolved over the course of several hours to a day after the infusion was terminated. No dose relationship was observed in clinical studies. For dose modifications in the event of infusion-related reactions, see sections 4.2 and 4.4.

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