Nebenwirkungen · Poherdy
Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 11
HOS-153644 · Präparat HOS-101026
Infusion-related reactions (IRRs) An infusion-related reaction was defined in the pivotal trials as any event reported as hypersensitivity, anaphylactic reaction, acute infusion-related reaction or cytokine release syndrome occurring during an infusion or on the same day as the infusion. In the pivotal trial CLEOPATRA, the initial dose of pertuzumab was given the day before trastuzumab and docetaxel to allow for the examination of pertuzumab-associated reactions. On the first day when only pertuzumab was administered, the overall frequency of infusion-related reactions was 9.8% in the placebo-treated group and 13.2% in the pertuzumab-treated group, with the majority of infusion-related reactions being mild or moderate. The most common infusion-related reactions (≥ 1.0%) in the pertuzumab-treated group were pyrexia, chills, fatigue, headache, asthenia, hypersensitivity and vomiting.
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