Nebenwirkungen · Herwenda
Herwenda 150 mg powder for concentrate for solution for infusion Herwenda 420 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 14
HOS-149392 · Präparat HOS-100044
In the pivotal metastatic studies of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9% and 12% when it was combined with paclitaxel compared with 1% – 4% for paclitaxel alone. For monotherapy, the rate was 6% – 9%. The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27%), and was significantly higher than for anthracycline/cyclophosphamide alone (7% – 10%). In a subsequent study with prospective monitoring of cardiac function, the incidence of symptomatic CHF was 2.2% in patients receiving trastuzumab and docetaxel, compared with 0% in patients receiving docetaxel alone. Most of the patients (79%) who developed cardiac dysfunction in these studies experienced an improvement after receiving standard treatment for CHF.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-08-18T17:30:00Z · SHA-256 0420b6f06ca3e337d4516096fe98f47fc8d3f966fddcad79ddc2566b63477530 · Passage 2ace3dba2d17139b8293fad8424151bf5f379074e5a27d5d0f8f742a1e2ade4b · Zeichen 17358–18195 im Abschnitt