Daunorubicin
Daunorubicin is an anthracycline antibiotic chemotherapy agent used primarily to treat various types of leukemia, including acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). It works by inserting itself between DNA base pairs, preventing cancer cells from multiplying and causing cell death. This medication is typically administered intravenously in combination with other chemotherapy drugs.
Daunorubicin is a chemotherapy drug used to treat certain leukemias by interfering with cancer cell DNA to stop their growth and division.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01DB02
- RxNorm
- 3109
- Generic
- Daunorubicin
- Class
- atc-l01
- Brands
- Vyxeos
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
first trimesteravoid use
daunorubicin is contraindicated in pregnancy due to teratogenic potential; discuss treatment alternatives with oncology and obstetric teams
comprehensive fetal monitoring including ultrasound and fetal echocardiography
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesteravoid use if possible
use only if benefits clearly outweigh risks; consider delaying treatment until after delivery if possible
regular fetal growth ultrasounds and non-stress tests
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
do not breastfeed during treatment and for at least 10 days after last dose due to secretion in breast milk
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyreduce starting dose by 20-25%
use reduced doses initially and adjust based on tolerability; monitor cardiac function closely due to increased cardiotoxicity risk with age
baseline and periodic left ventricular ejection fraction (LVEF) assessment, renal function monitoring
Use with caution and monitor for adverse effects.
pediatric_age
children adolescentsweight-based dosing with careful monitoring
dosing based on body surface area; cumulative doses should be monitored to limit cardiotoxicity risk; use in pediatric acute lymphoblastic and myeloid leukemias
frequent cardiac monitoring (echocardiograms), complete blood counts, liver function tests
Use with caution and monitor for adverse effects.
renal_impairment
moderate severereduce dose by 25-50% in severe impairment
adjust dose based on creatinine clearance; monitor renal function and hematologic parameters closely
frequent renal function tests (creatinine, BUN), complete blood counts
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate severesignificant dose reduction or avoid use
daunorubicin is extensively metabolized in liver; avoid in severe hepatic impairment; reduce dose by 50% in moderate impairment
frequent liver function tests, bilirubin, and cardiac monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
FDA approval year
Vyxeos (CPX-351) liposomal formulation approval
Drug class
Anthracycline antineoplastic agent
Primary indication
Primary therapeutic use in adults
Mechanism of action
Antineoplastic mechanism
Acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and other hematologic malignancies. It is often used in combination regimens for both adult and pediatric patients with these conditions.
Daunorubicin works by intercalating between DNA base pairs and inhibiting topoisomerase II, an enzyme essential for DNA replication and cell division. This causes DNA strand breaks and prevents cancer cells from reproducing, ultimately leading to cell death.
This medication is given intravenously and can cause significant cardiotoxicity, requiring regular heart monitoring. It is a vesicant and must be administered carefully to avoid tissue damage. Common side effects include bone marrow suppression, nausea, and hair loss.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy