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 15–16

HOS-147088 · Präparat HOS-099594

15 the adjuvant (when Phesgo was administered alone) and in the follow-up phases. Asymptomatic or mildly symptomatic (NYHA class II) declines in LVEF of at least 10 %-points from baseline and to < 50 % (confirmed by secondary LVEF) were not reported in Phesgo-treated patients and were reported in 0.4% of intravenous pertuzumab and trastuzumab-treated patients during the neoadjuvant phase (see sections 4.2 and 4.4). There was no report of asymptomatic or mildly symptomatic (NYHA class II) declines in LVEF of at least 10 % points from baseline and to < 50 % (confirmed by secondary LVEF) in both arms in the adjuvant phase. In the follow up phase, 1.6 % of Phesgo treated patients and 3.6 % of intravenous pertuzumab and trastuzumab-treated patients had this type of cardiac event.

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