Daunorubicin

Pronunciation: daw-noh-ROO-bi-sin.

Generic name
daunorubicin hydrochloride
Drug class
Anthracycline antibiotic antineoplastic (DNA-intercalating agent, topoisomerase II inhibitor)
Form
Solution for injection / powder for reconstitution, typically 20 mg vial
Route
Intravenous infusion only
Legal status
Prescription-only, hospital/oncology-specialist-administered, in every market reviewed

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Daunorubicin (as hydrochloride) (4) · Full directory

What daunorubicin hydrochloride is and how it works

Daunorubicin is an anthracycline antibiotic anticancer medicine, derived from the bacterium Streptomyces coeruleorubidis, that works by binding to DNA and inhibiting topoisomerase II, interrupting the synthesis of nucleic acids and stopping cancer cell division. It is given only by intravenous infusion in a hospital or specialist oncology setting, most often combined with other chemotherapy drugs to treat acute leukaemias. (1) (2)

Daunorubicin carries a serious, genuine FDA boxed warning -- the strongest safety warning the FDA issues -- because it can cause potentially fatal heart damage, severe reductions in blood cell counts, and severe tissue damage if it leaks outside the vein during administration. It must only be given, adjusted, continued, or stopped by an oncology team experienced in leukaemia chemotherapy, in a hospital equipped to manage these risks.

Mechanism of action: how daunorubicin hydrochloride works

Daunorubicin is an anthracycline antibiotic that intercalates into DNA and inhibits topoisomerase II, blocking DNA and RNA synthesis and arresting cell division; it is cell-cycle-phase-nonspecific with maximal effect in S-phase. (1) (5)

What daunorubicin hydrochloride is used for

Acute myeloid (nonlymphocytic) leukaemia

Used, usually combined with cytarabine, to help bring about remission in adults with acute myeloid leukaemia. (1) (5)

Acute lymphoblastic (lymphocytic) leukaemia

Used, usually combined with vincristine and a corticosteroid, to help bring about remission in children and adults with acute lymphoblastic leukaemia. (1) (2) (5)

Other cancers (select markets/historical use)

The Canadian product monograph also lists use in inducing remission in chronic myeloid leukaemia, reticulosarcoma, Ewing's tumour, Wilms' tumour, and lymphosarcoma; the New Zealand data sheet notes it has been investigated in disseminated neuroblastoma and rhabdomyosarcoma. These uses vary by market and clinical context. (3) (5)

Before taking daunorubicin hydrochloride

Do not take / not appropriate for

  • Must not be given to patients with a known hypersensitivity to daunorubicin or other anthracyclines. (all countries) (1) (2)
  • Must not be given to patients with myocardial (heart muscle) lesions, myocardial insufficiency, a recent heart attack, or severe arrhythmias. (Canada, United Kingdom) (3) (2)
  • The Canadian product monograph specifically contraindicates use in patients above 75 years of age because of cardiotoxicity risk. (Canada) (3)
  • Must not be given if a cumulative anthracycline dose of 500-600 mg/m2 (UK) or 25 mg/kg, exceptionally up to 30 mg/kg (Canada), has already been reached, because of cardiotoxicity risk. (United Kingdom, Canada) (2) (3)
  • Must not be given to patients with severe hepatic impairment (Child-Pugh Grade C) or severe renal impairment (GFR less than 10 mL/min or serum creatinine greater than 7.9 mg/dL). (New Zealand) (5)
  • Must not be given to patients with active chicken pox or herpes zoster, persistent myelosuppression, or severe infection. (United Kingdom) (2)
  • Must not be given during breastfeeding. (United Kingdom) (2)
  • Must never be given by the intramuscular or subcutaneous route. (all countries) (1) (5)

Tell your clinician about

  • Any history of heart disease, prior chest/mediastinal radiotherapy, or prior anthracycline treatment (e.g. doxorubicin, epirubicin, idarubicin) -- these raise cardiotoxicity risk and count toward lifetime cumulative dose limits.
  • Whether you are pregnant, could become pregnant, or are breastfeeding.
  • Any liver or kidney problems, since the dose must be reduced or withheld depending on severity.
  • Any current infection, fever, or recent chicken pox/shingles exposure.
  • All other medicines, especially other chemotherapy drugs that affect the bone marrow or heart.
(1) (2) (3) (5)

How to take daunorubicin hydrochloride

  • Given only as an intravenous infusion by a healthcare professional in a hospital or specialist oncology unit -- never taken as a tablet or given by injection into a muscle or under the skin.
  • Administered into a free-flowing IV line (usually with saline or dextrose) through a large vein, over at least 3-5 minutes; your care team will watch closely for any sign of leakage (extravasation) during the infusion.
  • Doses and treatment schedules are individualised by your oncology team based on your diagnosis, response, blood counts, and organ function -- there is no fixed patient-adjustable dose.
  • Your care team tracks your lifetime cumulative dose closely because of the cardiotoxicity risk, and will perform heart monitoring (such as ECG) before treatment and at intervals during it.
(1) (5)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

Not applicable in the usual patient-facing sense -- daunorubicin is given on a fixed treatment schedule determined and administered entirely by your oncology team in hospital. If a scheduled infusion needs to be delayed or adjusted (for example because of low blood counts or an infection), your care team will decide when and how to proceed; this is never a decision to make yourself.

Overdose

Because daunorubicin is only given by a healthcare professional under close monitoring, overdose is managed entirely by the treating hospital team, who will provide intensive supportive care (such as management of severe myelosuppression and cardiac monitoring) if it occurs. This is not a situation a patient or caregiver would need to respond to at home. (3)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Complete but reversible hair loss (alopecia).

What to notice: Complete but reversible hair loss (alopecia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (5)

Mild nausea, vomiting, and mouth sores (mucositis), typically appearing 3-7 days after a dose.

What to notice: Mild nausea, vomiting, and mouth sores (mucositis), typically appearing 3-7 days after a dose.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Red discolouration of urine for a short time after the infusion -- expected and not a cause for concern.

What to notice: Red discolouration of urine for a short time after the infusion -- expected and not a cause for concern.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (5)

Low blood cell counts (affecting nearly all patients), with the lowest point typically around 8-10 days after a dose and recovery within 2-3 weeks.

What to notice: Low blood cell counts (affecting nearly all patients), with the lowest point typically around 8-10 days after a dose and recovery within 2-3 weeks.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of heart problems (current or delayed, up to years later) — boxed_warning

Symptoms: Shortness of breath, swelling of the legs or ankles, unusual tiredness, or a rapid/irregular heartbeat -- these can appear during treatment or months to years after the last dose.

Action: Contact your oncology or cardiology team promptly for any of these symptoms, even long after treatment has finished -- daunorubicin's heart-toxicity risk is cumulative-dose-dependent and can be delayed and irreversible; do not wait for a routine visit if symptoms are new or worsening. (1) (2)

Signs of serious infection or bleeding from low blood counts — boxed_warning

Symptoms: Fever, chills, sore throat, unusual bruising or bleeding, or feeling extremely unwell.

Action: Seek urgent medical assessment immediately (contact your treating hospital's oncology unit or emergency department) -- severe myelosuppression from daunorubicin can lead to life-threatening infection or haemorrhage. (1)

Stinging, burning, or swelling at or around the IV site during the infusion — emergency

Symptoms: Pain, stinging, burning, redness, or swelling at the infusion site while the drip is running.

Action: Tell the nurse or doctor immediately -- this is the one situation where prompt patient reporting matters most, because daunorubicin can cause severe tissue damage (necrosis) if it leaks outside the vein (extravasation); the infusion team will stop and manage it right away. (5) (2)

Signs of a new blood cancer occurring after treatment (secondary leukaemia) — high caution

Symptoms: Unexplained bruising, persistent tiredness, recurrent infections, or abnormal blood counts noted at follow-up, occurring some time after daunorubicin treatment has finished.

Action: Attend all recommended long-term follow-up appointments -- secondary leukaemia is a recognised, genuine risk of daunorubicin and other topoisomerase II inhibitor chemotherapy, particularly when combined with other anticancer drugs or radiotherapy; your oncology team will monitor for this over time. (1) (2) (3)

Severe abdominal pain, diarrhoea, or fever suggesting bowel inflammation — high caution

Symptoms: Severe abdominal pain, watery or bloody diarrhoea, fever, and abdominal distension.

Action: Seek prompt medical assessment -- colitis, enterocolitis, and neutropenic enterocolitis (typhlitis) have been reported with daunorubicin and require immediate treatment discontinuation and medical management. (3)

Interactions

  • Combining daunorubicin with other anticancer drugs that also affect the bone marrow or the heart increases toxicity risk; your oncology team reduces individual drug doses accordingly when combination regimens are used. (3)
  • Prior treatment with other anthracyclines (such as doxorubicin, epirubicin, or idarubicin) or prior chest/mediastinal radiotherapy adds to lifetime cardiotoxicity risk and must be factored into cumulative-dose calculations. (2)
  • Tell your oncology team about all other medicines and supplements you take so interactions specific to your treatment regimen can be reviewed. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Daunorubicin is a cytotoxic chemotherapy agent; use during pregnancy requires individualised specialist oncology and obstetric assessment of risks and benefits. No source reviewed for this dossier authorised routine use in pregnancy. (1) (2) (3) (4) (5) (6)

Children

Used in children for acute lymphoblastic and acute myeloid leukaemia, with paediatric cumulative-dose limits that are lower than in adults (10 mg/kg under 2 years of age or under 0.5 m2 body surface area; 300 mg/m2 over 2 years of age), reflecting greater cardiotoxicity sensitivity in children. (1) (2) (3) (4) (5) (6)

Elderly

The Canadian product monograph contraindicates use above 75 years of age because of cardiotoxicity risk; the US label recommends a reduced dose (30 mg/m2/day instead of 45 mg/m2/day) for adults 60 and older. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Dose reduction required for impaired hepatic function; the New Zealand data sheet specifies the drug must not be given in severe impairment (Child-Pugh Grade C) and gives explicit dose reductions (one-half or one-quarter of the standard dose) based on bilirubin level for mild/moderate impairment. (1) (2) (3) (4) (5) (6)

Renal_impairment

Dose reduction required for impaired renal function; the New Zealand data sheet specifies the drug must not be given in severe impairment (GFR under 10 mL/min or serum creatinine over 7.9 mg/dL) and halves the dose in moderate impairment. (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-DAUNORUBICIN-2026,UK-EMC-DAUNORUBICIN-2026,CA-HC-CERUBIDINE-PM-2026,NZ-MEDSAFE-DAUNORUBICIN-2026 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Baseline heart assessment, including physical examination and ECG, and a review of any prior anthracycline exposure or chest radiotherapy.
  • Baseline full blood count and assessment of liver and kidney function.
  • Treatment of any active infection before starting daunorubicin.

During treatment

  • Regular full blood counts to monitor for severe myelosuppression, with the expected nadir around 8-10 days after a dose.
  • Ongoing cardiac monitoring (repeated ECG and clinical assessment), particularly as the cumulative dose approaches the cardiotoxicity threshold (around 15 mg/kg per the Canadian monograph, or 400-550 mg/m2 in adults per the US/UK labels).
  • Close visual monitoring of the IV site throughout each infusion for any sign of extravasation.
  • Ongoing monitoring for signs of infection, bleeding, and uric acid elevation (tumour lysis syndrome), especially early in treatment.
  • Long-term follow-up after treatment ends to monitor for delayed cardiotoxicity and secondary leukaemia.
(1) (2) (3)

Storage

Stored and handled entirely by hospital pharmacy and oncology staff according to manufacturer instructions and local cytotoxic-drug handling protocols; not a medicine stored or handled by patients at home.

Professional information

Clinician-facing context only, sourced from the current live US DailyMed label, the UK EMC SmPC, the Canadian product monograph, and the New Zealand Medsafe data sheet; verify against the current full label before prescribing.

United States

Indication: AML (with cytarabine) / ALL (with vincristine, prednisone)

Dose summary: AML: 45 mg/m2/day IV days 1-3 (course 1)/days 1-2 (later courses) under age 60; 30 mg/m2/day 60 and older. ALL: 25 mg/m2 IV weekly.

Renal context: Dose reduction required for hepatic or renal impairment (boxed warning); specific numeric thresholds not given in the US label reviewed. (1)

New Zealand

Indication: AML / ALL

Dose summary: Individualised 0.5-3 mg/kg per injection; lifetime cumulative dose ceiling 20 mg/kg.

Renal context: Contraindicated if GFR <10 mL/min or serum creatinine >7.9 mg/dL; halve dose if GFR 10-20 mL/min or serum creatinine ~3.4-7.9 mg/dL. Hepatic: contraindicated in Child-Pugh C; halve dose (bilirubin 1.2-3 mg/dL) or quarter dose (bilirubin >3 mg/dL) in mild/moderate impairment. (5)

Mechanism of action

Hepatic guidance

See special_populations.hepatic_impairment and the New Zealand data sheet's explicit bilirubin-based dose-reduction table.

Overdose note

No specific antidote identified in the sources reviewed; manage with intensive supportive care (haematological and cardiac) under oncology direction. (1) (5)

Frequently asked questions

Is daunorubicin available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes, in all six markets, though the exact brand name and authorisation route vary: FDA-approved generic injection in the United States, MHRA/EMC-licensed generic (Zentiva) in the United Kingdom, nationally authorised across European Union member states (rather than as a single centrally-authorised EMA product -- Vyxeos, a distinct liposomal combination, is separately centrally authorised), Health Canada-approved as Cerubidine, TGA-registered in Australia (ARTG 12723, Pfizer), and Medsafe-registered in New Zealand (Pfizer). (1) (2) (6) (3) (4) (5)

Why does daunorubicin have a boxed warning?

Daunorubicin's US boxed warning covers five serious risks: it must only be given by rapid intravenous infusion (never into a muscle or under the skin), and severe tissue damage occurs if it leaks outside the vein; it can cause potentially fatal heart damage that increases with the total cumulative dose received over a lifetime and can appear months to years after treatment ends; it causes severe reductions in blood cell counts that can lead to serious infection or bleeding; it should only be given by physicians experienced in leukaemia chemotherapy in well-equipped facilities; and the dose must be reduced in patients with liver or kidney problems. (1)

Does daunorubicin increase the risk of a second cancer later on?

Yes -- a real, documented risk of secondary leukaemia has been reported in patients treated with daunorubicin and other topoisomerase II inhibitor chemotherapy, particularly when combined with other anticancer drugs or radiotherapy. This risk is separate from, and not part of, the five-point US boxed warning, but it is a genuine long-term risk your oncology team will discuss with you and monitor for during follow-up. (1) (2) (3)

What is the mechanism of action of daunorubicin hydrochloride?

Daunorubicin is an anthracycline antibiotic that intercalates into DNA and inhibits topoisomerase II, blocking DNA and RNA synthesis and arresting cell division; it is cell-cycle-phase-nonspecific with maximal effect in S-phase. (1) (5)

What is the generic name of Daunorubicin?

The generic name is daunorubicin hydrochloride. (1) (3)

What class of drug is daunorubicin hydrochloride?

Daunorubicin is classed as: Anthracycline antibiotic antineoplastic (DNA-intercalating agent, topoisomerase II inhibitor). (1) (3)

References

  1. DAUNOrubicin Hydrochloride Injection -- full prescribing information (current label)U.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Meitheal Pharmaceuticals · United States · accessed 2026-07-31 · source 1
  2. Daunorubicin 20 mg Powder for I.V. Injection -- Summary of Product Characteristics (emc)electronic medicines compendium (emc), United Kingdom -- Zentiva · United Kingdom · accessed 2026-07-31 · source 2
  3. CERUBIDINE (daunorubicin hydrochloride for injection) 20 mg/vial -- Canadian Product MonographHealth Canada -- Product Monograph, Searchlight Pharma Inc. (Erfa Canada 2012 Inc. is an earlier monograph holder for the same product) · Canada · accessed 2026-07-31 · source 3
  4. DAUNORUBICIN (as hydrochloride) 20 mg/10 mL injection vial -- ARTG entry 12723 (Pfizer Australia)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-31 · source 4
  5. Pfizer (Perth) Daunorubicin 2 mg/mL solution for injection -- New Zealand Data SheetMedsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-31 · source 5
  6. Active substance: daunorubicin -- list of nationally authorised medicinal products (PSUSA/00000936/201506)European Medicines Agency (EMA) -- list of nationally authorised medicinal products containing daunorubicin (PSUSA procedure) · European Union · accessed 2026-07-31 · source 6

Brand names by country

Single-ingredient daunorubicin hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Daunorubicin Hydrochloride Injection (generic; historical brand Cerubidine) (1)FDA approved currently labeled · 20 mg/4 mL vial · Meitheal Pharmaceuticals / Hikma Pharmaceuticals (generic manufacturers)

United Kingdom

  • Daunorubicin 20 mg Powder for I.V. Injection (2)MHRA licensed emc smpc confirmed · 20 mg powder for injection vial · Zentiva

Canada

  • CERUBIDINE

Australia

  • Daunorubicin (as hydrochloride) (4)TGA ARTG registered 1991-08-13 confirmed still active · 20 mg/10 mL injection vial, 18.7 mg powder for injection vial · Pfizer Australia Pty Ltd

New Zealand

  • Pfizer (Perth) Daunorubicin (5)Medsafe data sheet confirmed · 2 mg/mL solution for injection · Pfizer New Zealand Limited
View brands in additional countries.

European Union

Daunorubicin (national brand names vary by member state; nationally authorised, not a single EU-wide centrally-authorised product) (6)

This page provides general reference information about daunorubicin and is not a substitute for advice from the oncology team managing your treatment. Daunorubicin is a hospital-administered chemotherapy medicine with a serious risk of heart damage, severe blood-count reductions, and tissue damage if it leaks outside the vein; all treatment decisions must be made with your oncology team.

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