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Epirubicin Hydrochloride

EPIRUBICIN HYDROCHLORIDE

Manufacturer: Hikma Pharmaceuticals USA Inc.

Score: 145.0

Quick Summary

Epirubicin Hydrochloride is an anthracycline cytotoxic agent used as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. It works by intercalating DNA strands, inhibiting nucleic acid synthesis, and inducing apoptosis. The recommended dose is 100-120 mg/m2, administered intravenously in repeated 3-4 week cycles. Important safety information includes the risk of cardiotoxicity, myelosuppression, and secondary acute myelogenous leukemia. Contraindications include cardiomyopathy, previous treatment with maximum cumulative dose of anthracyclines, and hypersensitivity to epirubicin or other anthracyclines.

Key Clinical Findings and Indications

  • Breast cancer adjuvant therapy
  • Anthacycline cytotoxic agent
  • Intercalates DNA strands, inhibiting nucleic acid synthesis and inducing apoptosis

Important Safety Information

Warning

Risk of cardiotoxicity, myelosuppression, and secondary acute myelogenous leukemia

Contraindications

  • Cardiomyopathy
  • Previous treatment with maximum cumulative dose of anthracyclines
  • Hypersensitivity to epirubicin or other anthracyclines

Adverse Reactions

  • Myelosuppression
  • Cardiotoxicity
  • Nausea and vomiting
  • Alopecia
  • Secondary acute myelogenous leukemia

Dosing Recommendations

General Guidance

Reduce dose in patients with hepatic impairment, severe renal impairment, or bone marrow dysfunction

Breast cancer

Adult Dose

100-120 mg/m2, administered intravenously in repeated 3-4 week cycles

Pediatric Dose

Special Population Considerations

Pregnancy

  • Pregnancy Category D
  • May cause fetal harm

Nursing Mothers

  • Epirubicin is excreted in human milk
  • Discontinue nursing or the drug

Pediatric Use

  • Safety and effectiveness not established in pediatric patients
  • May be at greater risk for anthracycline-induced cardiotoxicity

Geriatric Use

  • Particular care should be taken in monitoring toxicity in female patients ≥ 70 years of age