daunorubicin hydrochloride: clinical use

Prescribing considerations

• Use only under specialist supervision with facilities to manage profound myelosuppression, infection, haemorrhage and extravasation.
• Review previous anthracycline exposure, other cardiotoxic treatment and mediastinal radiotherapy.
• Assess hepatic and renal impairment because reduced clearance may increase toxicity.
• Evaluate infection, marrow reserve, oral ulceration, tumour-lysis risk and fertility-preservation needs before treatment.
• Avoid live vaccines and review concomitant cardiotoxic, myelosuppressive, hepatotoxic and antiplatelet treatments.

Contraindications and cautions

• Hypersensitivity to daunorubicin, another anthracycline or an excipient
• Persistent myelosuppression or severe infection
• Severe hepatic or renal impairment
• Myocardial insufficiency, recent myocardial infarction or severe arrhythmia
• Current or recent chickenpox or herpes zoster exposure or infection
• Previous exposure reaching the permitted cumulative limit for daunorubicin or another cardiotoxic anthracycline
• Breastfeeding
• Intramuscular administration

Monitoring

• Full blood count before and during treatment, with rapid management of infection, bleeding or cytopenias
• Cardiac assessment before, during and after treatment, including ECG and left-ventricular function where appropriate
• Liver and kidney function
• Urate, electrolytes and renal markers when tumour lysis is a concern
• Infusion site throughout administration
• Long-term cardiac follow-up where clinically appropriate, particularly after childhood treatment
• Possible secondary malignancy during long-term follow-up

Clinical pharmacology

Daunorubicin is an anthracycline glycoside that intercalates into DNA and inhibits nucleic-acid synthesis. It is rapidly distributed into tissues, metabolised mainly in the liver to active daunorubicinol, and eliminated through biliary and urinary routes; it does not appreciably cross the blood–brain barrier.

Formulation and product differences

• The selected product is a red lyophilised powder containing mannitol, requiring reconstitution with water for injections and dilution with sodium chloride solution before intravenous administration.
• The reconstituted solution is incompatible with heparin sodium injection and dexamethasone sodium phosphate.
• It is a conventional intravenous daunorubicin preparation, not a ready-to-use oral, intramuscular or subcutaneous formulation.

Injection

Route: Parenteral

Strengths: 20 mg