Epirubicin Hydrochloride

What it is and how it works

Mechanism of Action Epirubicin is an anthracycline cytotoxic agent. Although it is known that anthracyclines can interfere with a number of biochemical and biological functions within eukaryotic cells, the precise mechanisms of epirubicin's cytotoxic and/or antiproliferative properties have not been completely elucidated. Epirubicin forms a complex with DNA by intercalation of its planar rings between nucleotide base pairs, with consequent inhibition of nucleic acid (DNA and RNA) and protein synthesis. Such intercalation triggers DNA cleavage by topoisomerase II, resulting in cytocidal activity.

Indications

is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer .

Dosage and administration (summary)

• The recommended starting dose of ELLENCE is 100 to 120 mg/m 2 . Dosage reductions are possible when given in certain combinations . • Administer intravenously in repeated 3- to 4-week cycles, either total dose on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle . • Consider use of antiemetics when given in conjunction with other emetigenic drugs . • Patients administered the 120 mg/m 2 regimen of ELLENCE should receive prophylactic antibiotic therapy . • Adjust dosage after the first treatment cycle based on hematologic and nonhematologic toxicities . • Reduce dose in patients with hepatic impairment ( 2.3 , 8.6 ).

Contraindications

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 • Severe myocardial insufficiency . • Recent myocardial infarction .

Warnings and precautions

• Use in Patients with Hepatic Impairment: Monitor serum total bilirubin and AST levels before and during treatment with ELLENCE. In patients with elevated serum AST or serum total bilirubin, dosage reductions or discontinuation may be required ( 2.3 , 5.5 ). • Tumor Lysis Syndrome: 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 .

Pregnancy

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

Storage and supply

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.

Source: Epirubicin Hydrochloride (Ellence) — US FDA prescribing information, 2026-07-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.