Epirubicin

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Cardiac Toxicity
• Secondary Malignancies
• Extravasation and Tissue Necrosis
• Severe Myelosuppression
• Tumor-Lysis Syndrome
• Thrombophlebitis and Thromboembolic Events
• Potentiation of Radiation Toxicity and Radiation Recall

Who should not take it

ELLENCE is contraindicated in patients with:

• Severe myocardial insufficiency
• Recent myocardial infarction or severe arrhythmias, or previous treatment with maximum cumulative dose of anthracyclines
• Severe persistent drug-induced myelosuppression
• Severe hepatic impairment (defined as Child-Pugh Class C or serum bilirubin level greater than 5 mg/dL)
• Severe hypersensitivity to ELLENCE, other anthracyclines, or anthracenediones

Storing it

Store refrigerated between 2°C and 8°C (36°F and 46°F). Do not freeze. Protect from light.

Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15–25°C). Solution for injection should be used within 24 hours after removal from refrigeration.

ELLENCE is a hazardous drug. Follow applicable special handling and disposal procedures 1.