Nebenwirkungen · Perjeta
Perjeta 420 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11
HOS-126850 · Präparat HOS-096317
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 Perjeta was given the day before trastuzumab and docetaxel to allow for the examination of Perjeta- associated reactions. On the first day when only Perjeta was administered, the overall frequency of infusion-related reactions was 9.8% in the placebo-treated group and 13.2% in the Perjeta-treated group, with the majority of infusion-related reactions being mild or moderate. The most common infusion-related reactions (≥ 1.0%) in the Perjeta-treated group were pyrexia, chills, fatigue, headache, asthenia, hypersensitivity and vomiting.
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Version 2026-04-28T17:02:00Z · SHA-256 6016d8c18bd6393fee3263a4c99284c28598b1dd932428fe0deafc6401ff5816 · Passage 1d1b2bc167c27ae2f25ac151eda011bbd18a04fd4a11990b6457a8ca66b8516a · Zeichen 10349–11229 im Abschnitt