Idamycin PFS (idarubicin)
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Idarubicin wherever you encounter it, plus the key facts at a glance.
- Generic name
- Idarubicin
- Brand name
- Idamycin PFS
- Development code
- 4-demethoxydaunorubicin
- Drug class
- Anthracycline chemotherapy
- Manufacturer
- Pfizer (Idamycin PFS) and generic manufacturers
- How it's taken
- IV injection on days 1 to 3 of induction
An anthracycline used in place of daunorubicin in 7+3 induction, given by vein on 3 days with 7 days of cytarabine. Approved in 1990, and the only one of the 3 backbone chemotherapy drugs whose current label uses the words acute myeloid leukemia.
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Where Idarubicin fits
The alternative anthracycline to daunorubicin in 7+3 and the anthracycline in FLAG-IDA salvage chemotherapy.
How Idarubicin works
Like daunorubicin, idarubicin inserts between DNA bases and blocks topoisomerase II so leukemia cells cannot copy their DNA and die as they try to divide; it is more fat soluble than daunorubicin and enters cells faster[1].
Mechanism: Anthracycline that slips between DNA bases and blocks topoisomerase II
Side effects and safety
The idarubicin label carries boxed warnings for cardiomyopathy (heart muscle damage, including heart failure during or after treatment, more likely after earlier anthracyclines or with existing heart disease), secondary cancers such as treatment-related leukemia, and severe tissue damage if the drug leaks from the vein, along with severe marrow suppression and the need for dose reduction in liver or kidney impairment[1]. Common effects include infection, nausea, vomiting, hair loss, mouth sores, diarrhea, bleeding and red urine for a day or two.
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 Idarubicin
The usual dose is 12 mg/m2 a day by slow IV injection into a running line on days 1 to 3, with cytarabine 100 mg/m2 a day by continuous infusion for 7 days, in hospital; a second course may be given at a reduced dose if needed[1]. Heart function is assessed before treatment and cumulative anthracycline dose is tracked.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Clinical trial results
Development history
Idamycin was approved by the FDA on September 27, 1990 (NDA 050661); the ready-to-use Idamycin PFS followed in 1997 and generics are available[3].
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Common questions about Idarubicin
▸What is Idarubicin (Idamycin PFS)?
An anthracycline used in place of daunorubicin in 7+3 induction, given by vein on 3 days with 7 days of cytarabine. Approved in 1990, and the only one of the 3 backbone chemotherapy drugs whose current label uses the words acute myeloid leukemia.
▸How does Idarubicin work?
Like daunorubicin, idarubicin inserts between DNA bases and blocks topoisomerase II so leukemia cells cannot copy their DNA and die as they try to divide; it is more fat soluble than daunorubicin and enters cells faster[1].
▸What are the side effects of Idarubicin?
The idarubicin label carries boxed warnings for cardiomyopathy (heart muscle damage, including heart failure during or after treatment, more likely after earlier anthracyclines or with existing heart disease), secondary cancers such as treatment-related leukemia, and severe tissue damage if the drug leaks from the vein, along with severe marrow suppression and the need for dose reduction in liver or kidney impairment[1]. Common effects include infection, nausea, vomiting, hair loss, mouth sores, diarrhea, bleeding and red urine for a day or two.
▸How is Idarubicin taken?
The usual dose is 12 mg/m2 a day by slow IV injection into a running line on days 1 to 3, with cytarabine 100 mg/m2 a day by continuous infusion for 7 days, in hospital; a second course may be given at a reduced dose if needed[1]. Heart function is assessed before treatment and cumulative anthracycline dose is tracked.
▸Is Idarubicin FDA approved?
Yes, Idarubicin (Idamycin PFS) is FDA approved (1990) 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.
- Pfizer via openFDA · 2026-04-15. Idamycin PFS (idarubicin hydrochloride injection) prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%220a5a6d93-cc1e-4d7f-8da1-446c134503b3%22
- Astellas via DailyMed · 2026-10-01. Xospata (gilteritinib) tablets prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5ff59aa-9c0d-49a8-9053-1f179b482383
- FDA. Idamycin approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050661