Daunorubicin
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Daunorubicin wherever you encounter it, plus the key facts at a glance.
- Generic name
- Daunorubicin
- Development code
- daunomycin
- Drug class
- Anthracycline chemotherapy
- Manufacturer
- Generic manufacturers (Hikma and others)
- How it's taken
- IV infusion on days 1 to 3 of induction
The 3 in 7+3: an anthracycline given by vein on 3 days of induction with 7 days of cytarabine, sold only as generics since the Cerubidine brand was discontinued. Approved in 1979 for remission induction in acute nonlymphocytic leukemia (AML) in adults, it is the chemotherapy partner in the RATIFY, QuANTUM-First and ALFA-0701 regimens and one half of Vyxeos.
We'll email you when Daunorubicin's FDA label changes, when the FDA acts on it, and when new trials for Acute Myeloid Leukemia open. Unsubscribe anytime.
You'll get new recruiting trials, changes to trials, FDA decisions and condition news for Acute Myeloid Leukemia. Turn any of these off from the link in every email.
Where Daunorubicin fits
The standard anthracycline in 7+3; idarubicin is the alternative. Both are only for people fit enough for intensive chemotherapy.
How Daunorubicin works
Daunorubicin wedges itself between the bases of DNA and traps topoisomerase II, the enzyme that unwinds DNA for copying, which leaves breaks in the strands and kills dividing leukemia cells. It also generates reactive oxygen molecules, which contribute to its effect and to its damage to heart muscle[1].
Mechanism: Anthracycline that slips between DNA bases and blocks topoisomerase II, so dividing cells cannot copy their DNA
Side effects and safety
The daunorubicin label carries boxed warnings: it must be given into a fast-running IV line and never into muscle or under the skin because leakage causes severe tissue death; it can cause heart muscle damage and potentially fatal heart failure, with the risk rising as the lifetime total dose approaches 550 mg/m2 (lower with chest radiation or other heart-toxic drugs); it causes severe marrow suppression; doses must be reduced in liver or kidney impairment; and it should be given by experienced physicians[1]. Other effects include nausea, vomiting, mouth sores, hair loss, red-colored urine for a day or two and, rarely, a second cancer years later.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Daunorubicin
In 7+3 induction, daunorubicin 60 mg/m2 a day (sometimes 45 or 90 mg/m2) is infused on days 1 to 3 with 7 days of continuous cytarabine; a second induction, if needed, uses 2 days[2][3]. Heart function is checked by echocardiogram or MUGA scan before starting and the cumulative dose is tracked for life[1].
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Clinical trial results
Development history
Cerubidine was approved by the FDA on December 19, 1979 (NDA 050484); the brand is discontinued and generic daunorubicin hydrochloride injection remains available[5].
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Common questions about Daunorubicin
▸What is Daunorubicin?
The 3 in 7+3: an anthracycline given by vein on 3 days of induction with 7 days of cytarabine, sold only as generics since the Cerubidine brand was discontinued. Approved in 1979 for remission induction in acute nonlymphocytic leukemia (AML) in adults, it is the chemotherapy partner in the RATIFY, QuANTUM-First and ALFA-0701 regimens and one half of Vyxeos.
▸How does Daunorubicin work?
Daunorubicin wedges itself between the bases of DNA and traps topoisomerase II, the enzyme that unwinds DNA for copying, which leaves breaks in the strands and kills dividing leukemia cells. It also generates reactive oxygen molecules, which contribute to its effect and to its damage to heart muscle[1].
▸What are the side effects of Daunorubicin?
The daunorubicin label carries boxed warnings: it must be given into a fast-running IV line and never into muscle or under the skin because leakage causes severe tissue death; it can cause heart muscle damage and potentially fatal heart failure, with the risk rising as the lifetime total dose approaches 550 mg/m2 (lower with chest radiation or other heart-toxic drugs); it causes severe marrow suppression; doses must be reduced in liver or kidney impairment; and it should be given by experienced physicians[1]. Other effects include nausea, vomiting, mouth sores, hair loss, red-colored urine for a day or two and, rarely, a second cancer years later.
▸How is Daunorubicin taken?
In 7+3 induction, daunorubicin 60 mg/m2 a day (sometimes 45 or 90 mg/m2) is infused on days 1 to 3 with 7 days of continuous cytarabine; a second induction, if needed, uses 2 days[2][3]. Heart function is checked by echocardiogram or MUGA scan before starting and the cumulative dose is tracked for life[1].
▸Is Daunorubicin FDA approved?
Yes, Daunorubicin is FDA approved (1979) for the treatment of Acute Myeloid Leukemia.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- openFDA · 2024-02-15. Daunorubicin hydrochloride injection prescribing information (Hikma). https://api.fda.gov/drug/label.json?search=set_id:%22227784a8-ce68-4dd4-8ac5-a65265969677%22
- Novartis via openFDA · 2026-06-08. Rydapt (midostaurin) capsules prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%2211fa3fc9-6776-49a6-b1c1-653f627c3e58%22
- Pfizer via openFDA · 2025-12-19. Mylotarg (gemtuzumab ozogamicin) for injection prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%2232fd2bb2-1cfa-4250-feb8-d7956c794e05%22
- Jazz Pharmaceuticals via openFDA · 2026-01-30. Vyxeos (daunorubicin and cytarabine) liposome for injection prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%227ea701ce-e7d3-4349-a9c2-642a501d45c8%22
- FDA. Cerubidine approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050484