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Anthracycline (specialist) Pregnancy: Can cause fetal harm based on mechanism of action and animal findings; avoid during the 1st trimester. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Teratogenic and embryotoxic in animals.

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: Single agent: 60 to 75 mg/m2 intravenously every 21 days. In combination with other chemotherapy: 40 to 75 mg/m2 intravenously every 21 to 28 days. Adjuvant breast cancer: 60 mg/m2 as an IV bolus on day 1 of each 21-day cycle, in combination with cyclophosphamide, for a total of four cycles.
Route: Intravenous injection (through a central line or secure, free-flowing peripheral line), given over 3 to 10 minutes
Frequency: Every 21 days (single agent) or every 21 to 28 days (combination)
Max: Cumulative doses above 550 mg/m2 increase cardiomyopathy risk (dose-limiting cumulative exposure)
US FDA labelling (specialist/oncology use — cytotoxic, hazardous drug). Consider the lower dose or longer intervals for heavily pretreated, elderly or obese patients. Cumulative doses above 550 mg/m2 are associated with increased risk of cardiomyopathy; include prior anthracycline/anthracenedione doses in cumulative totals. Discontinue if signs or symptoms of cardiomyopathy develop. Hepatic impairment dose modification by serum total bilirubin: 1.2-3 mg/dL give 50% of dose; 3.1-5 mg/dL give 75% of dose; greater than 5 mg/dL do not initiate/discontinue. Contraindicated in severe hepatic impairment (Child-Pugh Class C or bilirubin >5 mg/dL). Do NOT administer in combination with trastuzumab (increased cardiac dysfunction risk).

Dose adjustments

Renal

Not stated in this source (US label gives hepatic-impairment dose modifications only)

Dose auto-extracted from 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

  • Severe myocardial insufficiency
  • Recent (within the past 4-6 weeks) myocardial infarction
  • Severe persistent drug-induced myelosuppression
  • Severe hepatic impairment (Child-Pugh Class C or serum bilirubin >5 mg/dL)
  • Severe hypersensitivity reaction to doxorubicin hydrochloride, including anaphylaxis

Side effects

  • Most common (>10%): alopecia, nausea and vomiting
  • Cardiomyopathy and arrhythmias (including acute left ventricular failure; risk proportional to cumulative dose)
  • Severe myelosuppression
  • Extravasation and tissue necrosis
  • Secondary malignancies; tumor lysis syndrome; radiation sensitisation and radiation recall

Interactions

  • Avoid concomitant use with inhibitors of CYP3A4, CYP2D6 or P-gp (increased doxorubicin concentrations, more/severe adverse reactions)
  • Avoid concomitant use with inducers of CYP3A4, CYP2D6 or P-gp (decreased doxorubicin concentration)
  • Paclitaxel given prior to doxorubicin increases doxorubicin/metabolite plasma concentrations — administer doxorubicin before paclitaxel if used concomitantly
  • Do not administer with trastuzumab (increased risk of cardiac dysfunction)

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.

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