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Anthracycline (specialist) Pregnancy: Crosses the placenta; mutagenic, carcinogenic and teratogenic in animals. Should not be used during pregnancy unless the woman's condition requires it and justifies the potential foetal risk. Women of childbearing potential must use effective contraception; men should use contraception during and up to 6 months after treatment and be counselled on sperm conservation. Contraindicated during breast-feeding.

Daunorubicin

Brand names: Cerubidin

Daunorubicin is an anthracycline cytotoxic antibiotic used principally in the induction treatment of acute leukaemias (both myeloid and lymphoblastic).

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 40-60 mg/m2 (induction); 45 mg/m2 for acute myelogenous leukaemia or acute lymphocytic leukaemia
Route: Intravenous (after dilution only)
Frequency: On alternate days for a course of up to three injections (for induction of remission)
Max: Cumulative: adults 500-600 mg/m2; children over 2 years 300 mg/m2; children under 2 years (or below 0.5 m2 BSA) 10 mg/kg. Exceeding the cumulative maximum markedly increases risk of life-threatening cardiac damage.
Adults: 40-60 mg/m2 on alternate days for a course of up to three injections for induction of remission; recommended dose for both acute myelogenous leukaemia and acute lymphocytic leukaemia is 45 mg/m2. Number of injections varies by patient and is determined by response and tolerance. Administer with caution when neutrophil count is <1,500/mm3; consider dose reduction in severe neutropenia. Extremely irritating to tissues - give only IV after dilution, through a large free-flowing vein. Elderly / inadequate bone marrow reserve: reduction of up to 50% recommended. Paediatric (over 2 years): dosage calculated on body surface area and adjusted to clinical response and haematological status; courses may be repeated after 3 to 6 weeks; consult current specialised protocols/guidelines.

Dose adjustments

Renal

Reduce dose 25% if serum creatinine 105-265 micromol/l; reduce 50% if creatinine above 265 micromol/l. (Hepatic: reduce 25% if bilirubin 20-50 micromol/l; 50% if bilirubin above 50 micromol/l.) Severe renal impairment is a contraindication.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, any anthracyclines or to any of the excipients
  • Recent exposure to, or existing, chicken pox or herpes zoster
  • Persistent myelosuppression
  • Severe infection
  • Severe hepatic or renal function impairment
  • Myocardial insufficiency, recent myocardial infarction, or severe arrhythmias
  • Must not be given by the intramuscular route; must not be used if cumulative maximum dose of daunorubicin or another cardiotoxic anthracycline already administered; breastfeeding

Side effects

  • Bone marrow failure, leucopenia, anaemia, granulocytopenia (neutropenia), thrombocytopenia
  • Serious infections including sepsis, septic shock and pneumonia
  • Cardiomyopathy and congestive heart failure, myocardial ischaemia/infarction, arrhythmias
  • Mucositis/stomatitis, oesophagitis, diarrhoea, nausea, vomiting, abdominal pain
  • Alopecia (reversible), skin/nail hyperpigmentation; red discolouration of urine for 1-2 days; extravasation causing severe tissue necrosis

Clinical monograph

How it works

It intercalates into DNA and inhibits topoisomerase II, causing DNA strand breaks, and also generates free radicals, leading to impaired DNA/RNA synthesis and cell death.

Prescribing in practice

  • It is cardiotoxic with a cumulative lifetime dose limit (risk of irreversible cardiomyopathy and heart failure), so prior anthracycline exposure and cardiac function must be assessed and cumulative dose tracked.
  • It is a potent vesicant causing severe necrosis on extravasation and produces marked myelosuppression.
  • A specialist cytotoxic given only within haemato-oncology protocols per the SPC.

Monitoring

Monitor cardiac function (including left ventricular ejection fraction), full blood count and cumulative anthracycline dose throughout treatment.

Counselling the patient

  • Report breathlessness, ankle swelling or palpitations, which may indicate effects on the heart.
  • The urine may turn red for a day or two after dosing, which is harmless.
  • Report any pain or swelling at the injection site at once, and use effective contraception.

Evidence & guidelines

Daunorubicin is a long-established component of acute leukaemia induction regimens, supported by extensive trial evidence and the SPC.

Reference: BSH AML; ESMO; UKONS; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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