epirubicin hydrochloride: clinical use

Prescribing considerations

• Administer only under specialist supervision with facilities for managing cytotoxic complications and extravasation.
• Account for previous anthracycline exposure, prior mediastinal radiotherapy and concurrent or previous cardiotoxic therapy.
• Confirm recovery from important toxicity of previous cytotoxic treatment before administration.
• Review hepatic function because hepatobiliary clearance is the main elimination route.
• For intravesical use, exclude invasive disease and assess infection, bleeding, inflammation, residual urine and feasibility of catheterisation.
• Discuss contraception and fertility preservation before treatment where relevant.

Contraindications and cautions

• Hypersensitivity to epirubicin, other anthracyclines or anthracenediones, or formulation excipients; breastfeeding.
• Intravenous use: persistent myelosuppression, severe hepatic impairment, significant active cardiac disease, previous maximum cumulative anthracycline exposure or acute systemic infection.
• Some selected product information additionally contraindicates severe gastrointestinal mucosal inflammation.
• Intravesical use: urinary infection, cystitis, haematuria, invasive bladder tumour or catheterisation difficulty; one selected product additionally lists contracted bladder and a large residual urine volume.

Monitoring

• Full blood count before and during treatment.
• Baseline and ongoing cardiac assessment, considering delayed cardiomyopathy after treatment.
• Bilirubin and transaminases before and during treatment; renal function as clinically indicated.
• Urate, potassium, calcium, phosphate and creatinine where tumour-lysis syndrome is a concern.
• Administration site during intravenous treatment and subsequent tissue assessment after suspected extravasation.
• Renal function during intravesical treatment if vesicorenal reflux is present.

Clinical pharmacology

Epirubicin is an anthracycline cytotoxic antibiotic that binds DNA and inhibits nucleic-acid synthesis and mitosis. It undergoes extensive tissue distribution and predominantly hepatobiliary elimination. Systemic absorption after intravesical administration is usually low but may increase when bladder mucosa is damaged.

Formulation and product differences

• The selected products are red, preservative-free aqueous solutions intended for specialist intravenous or intravesical use; Pharmorubicin is specifically described as a solution for injection or infusion.
• The selected product information differs in licensed systemic cancer indications and some intravesical contraindications; prescribing and preparation should follow the information for the actual product supplied.
• Avoid prolonged contact with alkaline solutions and do not mix with heparin.

Injection

Route: Parenteral

Strengths: 2 mg/mL