Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Phesgo

Phesgo 600 mg/600 mg solution for injection Phesgo 1 200 mg/600 mg solution for injection · Abschnitt 4.8 · PDF-Seite 18

HOS-147111 · Präparat HOS-099594

In the pivotal trial CLEOPATRA, the majority of patients in both treatment groups experienced at least one leucopenic event (63 % of patients in the pertuzumab-treated group and 58.3 % of patients in the placebo-treated group), of which the majority were neutropenic events (see section 4.4). Febrile neutropenia occurred in 13.7 % of pertuzumab-treated patients and 7.6 % of placebo-treated patients. In both treatment groups, the proportion of patients experiencing febrile neutropenia was highest in the first cycle of therapy and declined steadily thereafter. An increased incidence of febrile neutropenia was observed among Asian patients in both treatment groups compared with patients of other races and from other geographic regions. Among Asian patients, the incidence of febrile neutropenia was higher in the Pertuzumab-treated group (25.8 %) compared with the placebo-treated group (11.3 %).

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