Classes
DEA Class; Rx
Common Brand Names; Ellence
- Antineoplastics, Anthracycline
Description
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
Indications
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.
Contraindications
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)
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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.
How supplied
Epirubicin hydrochloride
- 2mg/mL as single dose vial containing 50mg/25mL or 200mg/100mL