Sorry, you need to enable JavaScript to visit this website.

ELLENCE® (epirubicin HCl) Boxed Warning

WARNING: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION

  • Cardiac Toxicity: Myocardial damage, including acute left ventricular failure, can occur with ELLENCE. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 0.9% at a cumulative dose of 550 mg/m2, 1.6% at 700 mg/m2, and 3.3% at 900 mg/m2. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with ELLENCE [see Warnings and Precautions (5.1)].
  • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including ELLENCE [see Warnings and Precautions (5.2)].
  • Extravasation and Tissue Necrosis: Extravasation of ELLENCE can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area [see Warnings and Precautions (5.3)].
  • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4)].

What's New

No Current Announcements.

Contact Pfizer Medical

Search

Please enter your search term(s) for ELLENCE®
×

Sollten Sie Probleme mit der Anmeldung über Ihr DocCheck Konto haben, deaktivieren Sie „Cross-Sitetracking verhindern“ unter Einstellungen / Safari / Datenschutz & Sicherheit.

×

Ihre derzeitige Browsereinstellung erlaubt keine Anmeldung über Ihr DocCheck Konto. Bitte wählen Sie den „Desktop-Version“ Modus unter dem Dreipunkt-Menu Ihres Browsers.

×

Safari-Nutzer: Sollten Sie Probleme mit der Anmeldung über Ihr DocCheck Konto haben, deaktivieren Sie „Cross-Sitetracking verhindern“ unter Einstellungen / Safari / Datenschutz & Sicherheit.