Epirubicin

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

Adults

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

Geriatric

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

Adolescents

Safety and effectiveness have not been established.

Children

Safety and effectiveness have not been established.

Epirubicin hydrochloride

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

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