Anthracycline (specialist)
Pregnancy: Doxorubicin should not be given during pregnancy and is contraindicated in pregnancy and lactation. Cytostatics should only be given in pregnancy on strict indication, with benefit to the mother weighed against possible hazards to the foetus; animal studies show embryo-, foeto- and teratogenic effects. Men and women should use effective contraception during and for up to 6 months after treatment. Breast-feeding should be discontinued during treatment.
Doxorubicin hydrochloride
Brand names: Adriamycin, Caelyx (pegylated liposomal), Myocet
Doxorubicin hydrochloride is an anthracycline cytotoxic antibiotic used to treat a wide range of haematological and solid tumours.
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: 60-75 mg/m2 body surface area as a single dose, or in divided doses on 2-3 consecutive days
Route: Intravenous — the concentrate is injected via the tubing of a freely-running intravenous infusion (sodium chloride 0.9% or dextrose 5%) over 2-15 minutes; this minimises the risk of thrombophlebitis or perivenous extravasation. A direct push injection is NOT recommended because of the risk of extravasation. The same product is also given by intravesical instillation for superficial bladder cancer (see notes).
Frequency: At 21-day intervals
Max: The cumulative total lifetime dose of doxorubicin (including related drugs such as daunorubicin) should not exceed 450-550 mg/m2 body surface area. 450 mg/m2 should not be exceeded in patients with previous radiation of the mediastinum, or previous or concomitant treatment with potentially cardiotoxic agents.
Treatment should be started by or after consultation with a doctor with extensive experience of cytostatic treatment. The dose depends on the dosage regimen, general status and previous treatment of the patient — several dosage regimens exist. Give the LOWER dose to patients with bone marrow depression. IN COMBINATION with other cytostatics the dose should be reduced to 30-60 mg/m2. For patients who cannot receive the full dose (e.g. immunosuppression, old age), an alternative dosage is 15-20 mg/m2 body surface per week. HEPATIC IMPAIRMENT — the SPC table is headed 'Recommended dose': serum bilirubin 20-50 micromol/L = 50% of the normal dose; serum bilirubin greater than 50 micromol/L = 25% of the normal dose (i.e. the figures are the fraction of the normal dose to GIVE). INTRAVESICAL ADMINISTRATION (treatment of superficial cancer of the bladder and prevention of relapse after transurethral resection): 30-50 mg in 25-50 ml physiological saline per instillation; the solution should remain in the bladder for 1-2 hours, with the patient turned 90 degrees every 15 minutes; the patient should be told not to drink anything for 12 hours before the instillation; the instillation may be repeated at intervals of 1 week to 1 month depending on whether treatment is therapeutic or prophylactic. Intravesical instillation is CONTRAINDICATED in invasive bladder tumours. MONITORING: measure liver function (AST, ALT, ALP, bilirubin) and renal function before starting; assess left ventricular ejection fraction by ultrasound or heart scintigraphy before treatment starts and after each accumulated dose of approximately 100 mg/m2. PAEDIATRIC: the SPC gives no numeric paediatric dose — it states only 'Dosage in children may need to be reduced, please refer to treatment protocols and the specialist literature'; verify against the relevant treatment protocol and a children's formulary. PRODUCT SCOPE: source SPC is 'Doxorubicin 2 mg/ml Concentrate for solution for infusion' — the conventional (non-liposomal) product. This bundle contains NO source for pegylated liposomal doxorubicin; that formulation's dosing differs and must be sourced separately.
Dose adjustments
Renal
In renal insufficiency with a GFR less than 10 ml/min, 75% of the calculated dose should be administered.
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 doxorubicin, other anthracyclines or anthracenediones
- Intravenous route — remaining myelosuppression or severe stomatitis which appeared during previous cytotoxic treatment; general infection; severe impaired liver function
- Intravenous route — severe arrhythmia, impaired heart function, previous cardiac infarct
- Intravenous route — previous treatment with anthracyclines with maximal cumulative doses
- Intravesical route — invasive tumours that have penetrated the bladder (beyond T1), urinary tract infections, inflammation of the bladder, problems with catheterisation
- Pregnancy and lactation
Side effects
- Bone-marrow suppression — the acute dose-limiting adverse effect, mostly transient; maximal at 10-14 days with counts usually normalised by day 21; may cause fever, infection, sepsis/septic shock, haemorrhage, tissue hypoxia or death
- Cardiomyopathy (2%; e.g. decrease of LVEF, dyspnoea) and ECG changes (sinus tachycardia, tachyarrhythmia, ventricular tachycardia, bradycardia, bundle branch block)
- Nausea, vomiting, mucositis, anorexia, diarrhoea
- Alopecia — nausea, vomiting and alopecia are seen in almost all patients
- Local reactions (chemical cystitis) with intravesical treatment; rarely conjunctivitis, urticaria, exanthema, local erythematous reactions along the injection vein, hyperpigmentation of skin and nails, onycholysis, anaphylactic reactions, and rarely secondary acute myeloid leukaemia
Interactions
- (US label — no eMC section 4.5 was retrieved in this bundle) Inhibitors of CYP3A4, CYP2D6 or P-glycoprotein increase doxorubicin concentrations and may increase the incidence and severity of adverse reactions — avoid concomitant use
- (US label) Inducers of CYP3A4, CYP2D6 or P-gp may decrease the concentration of doxorubicin — avoid concomitant use
- (US label) Paclitaxel given before doxorubicin increases plasma concentrations of doxorubicin and its metabolites — administer doxorubicin before paclitaxel if used concomitantly
- (US label) Trastuzumab — concomitant use results in an increased risk of cardiac dysfunction; do not administer in combination
- (eMC section 4.8) In combination with cytarabine, ulceration and necrosis of the colon, in particular the caecum, have been reported
Clinical monograph
How it works
It intercalates into DNA and inhibits topoisomerase II, and generates free radicals, disrupting DNA synthesis and replication in dividing cells.
Prescribing in practice
- Cumulative dose-related cardiotoxicity is the defining hazard, so lifetime cumulative exposure must be tracked and cardiac function assessed before and during treatment.
- It is a potent vesicant and extravasation causes severe tissue necrosis, so it is administered via secure intravenous access by experienced staff.
- Dose modification is required in hepatic impairment as it is largely cleared by the liver.
Monitoring
Monitor full blood count, cardiac function (including ejection fraction) and liver function, and keep a record of cumulative anthracycline dose.
Counselling the patient
- Your urine may turn red for a day or two after treatment, which is harmless.
- Report breathlessness or ankle swelling, and tell the team at once if you feel pain or burning at the infusion site.
Evidence & guidelines
Doxorubicin is a long-established component of many standard chemotherapy regimens, with cumulative cardiotoxicity well characterised in the literature.
Reference: ESMO breast/lymphoma/sarcoma guidelines; UKONS extravasation; 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.