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    DEA Class; Rx

    Common Brand Names; Ellence

    • Antineoplastics, Anthracycline

    Anthracycline topoisomerase inhibitor
    Used for node-positive early breast cancer
    Contraindicated in patients with severe drug-induced myelosuppression, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, and severe hepatic impairment

    Indicated as a component of adjuvant therapy in patient with evidence of axillary node tumor involvement following resection of primary breast cancer

    For the treatment of breast cancer.

    Severe hypersensitivity to drug, other anthracyclines, or anthracenediones

    Baseline ANC<1500/mm³

    Cardiomyopathy and/or heart failure, recent MI, or severe arrhythmias

    Severe myocardial insufficiency

    Cumulative dose achieved in previous anthracycline treatment

    Severe persistent drug-induced myelosuppression

    Severe hepatic impairment (Child-Pugh Class C or serum bilirubin level greater than 5 mg/dL)

    • Alopecia (96%)
    • Nausea and vomiting (92%)
    • Leukopenia or neutropenia (80%)
    • Amenorrhea (72%)
    • Anemia (72%)
    • Mucositis (59%)
    • Thrombocytopenia (49%)
    • Lethargy (46%)
    • Hot flashes (39%)
    • Diarrhea (25%)
    • Conjunctivitis (15%)
    • Rash (9%)
    • Fever (5%)
    • Skin changes (5%)
    • Anorexia (3%)

    Lysis syndrome may occur; evaluate blood uric acid levels, potassium, calcium, phosphate, and creatinine after initial treatment; consider hydration, urine alkalinization, and prophylaxis with allopurinol to minimize potential complications of hyperuricemia and tumor lysis syndrome

    Thrombophlebitis and thromboembolic events, including pulmonary embolism (in some cases fatal) reported with therapy; venous sclerosis may result from an injection into small vessel or from repeated injections into same vein

    Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents may result in serious or fatal infections

    Administration after previous radiation therapy may induce an inflammatory recall reaction at site of irradiation

    Therapy can cause fetal harm; advise patients of potential risk to a fetus and to use effective contraception

    Women of child-bearing potential should be advised to avoid becoming pregnant during treatment and should use effective contraceptive methods

    Verify pregnancy status in female patients of reproductive potential prior to initiating

    Based on findings from animal studies and mechanism of action, drug can cause fetal harm when administered to a pregnant woman; avoid use during the 1st trimester

    There are no data on presence of drug in human milk, effects on breastfed child, or on milk production; drug is present in rat milk; when a drug is present in animal milk it is likely the drug will be present in human milk


    120 mg/m2 per dose as a single agent. The maximum cumulative dose of epirubicin is 900 mg/m2.


    120 mg/m2 per dose as a single agent. The maximum cumulative dose of epirubicin is 900 mg/m2.


    Safety and effectiveness have not been established.


    Safety and effectiveness have not been established.

    Epirubicin hydrochloride

    injectable solution
    • 2mg/mL as single dose vial containing 50mg/25mL or 200mg/100mL