Cardiac Toxicity, Secondary Malignancies, Extravasation & Tissue Necrosis, and Severe Myelosuppression
- Myocardial damage, including acute left ventricular failure, can occur with epirubicin. 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 epirubicin.
- Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including epirubicin.
Extravasation and Tissue Necrosis
- Extravasation of epirubicin 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.
- Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Perform blood counts and liver function tests before and during each cycle administered. Repeated evaluations of left ventricular ejection fraction should be performed during therapy.
- Cumulative dose > 900 mg/m2 should be used with extreme caution.
- Cardiac risk increases with cumulative doses from 550 mg/m2 to 900 mg/m2