Nebenwirkungen · Zolsketil pegylated liposomal
ZOLSKETIL pegylated liposomal 2 mg/mL concentrate for dispersion for infusion · Abschnitt 4.8 · PDF-Seite 15
HOS-146370 · Präparat HOS-099502
In patients with solid tumours, including a subset of patients with breast and ovarian cancers, treated at a dose of 50 mg/m2/cycle with lifetime cumulative anthracycline doses up to 1,532 mg/m2, the incidence of clinically significant cardiac dysfunction was low. Of the 418 patients treated with doxorubicin pegylated liposomal 50 mg/m2/cycle, and having a baseline measurement of left ventricular ejection fraction (LVEF) and at least one follow-up measurement assessed by MUGA scan, 88 patients had a cumulative anthracycline dose of > 400 mg/m2, an exposure level associated with an increased risk of cardiovascular toxicity with conventional doxorubicin. Only 13 of these 88 patients (15%) had at least one clinically significant change in their LVEF, defined as an LVEF value less than 45% or a decrease of at least 20 points from baseline. Furthermore, only 1 patient (cumulative
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Version 2026-04-16T15:10:00Z · SHA-256 749f25cb02ef3c2557fff9c44c8608815445daccd9aad038fce4e840c7fa1845 · Passage 4137ab2b4e74df03c037ec94e2e5b9891fe2510d9c7f7e539c693de8b584db33 · Zeichen 16146–17033 im Abschnitt