Molecule
Idarubicin is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. It is available as injection for intravenous use. MedsAcross supplies Idarubicin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. IDAMYCIN PFS is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen.
Source: US FDA prescribing information
Idarubicin hydrochloride has antimitotic and cytotoxic activity through forming complexes with the DNA, inhibiting nucleic acid synthesis, inhibiting topoisomerase II activity, and producing DNA-damaging free radicals.
Source: US FDA prescribing information
Induction Therapy • 12 mg/m 2 intravenously over 10 to 15 minutes on days 1, 2, and 3 of induction in combination with cytarabine 100 mg/m 2 by continuous intravenous infusion daily for 7 days or cytarabine 25 mg/m 2 intravenous bolus followed by cytarabine 200 mg/m 2 continuous intravenous infusion daily for 5 days. • IDAMYCIN PFS can be given as part of a combination regimen with other chemotherapeutic drugs. • Renal Impairment: Assess renal function prior to therapy. Reduce dosage in renal impairment. • Hepatic Impairment: Assess hepatic function prior to therapy. Avoid or reduce dosage in hepatic impairment. See full prescribing information for preparation and administration instructions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (cardiomyopathy, secondary malignancies, and extravasation and tissue necrosis •): Cardiomyopathy: IDAMYCIN PFS can cause myocardial damage, including acute left ventricular failure, during or after termination of therapy. The risk of cardiomyopathy is increased in patients who have received prior anthracyclines or who have pre-existing cardiac disease. • Myelosuppression: Severe myelosuppression resulting in severe infection, septic shock, hemorrhage, or death may occur. Obtain complete blood counts prior to each treatment and closely monitor patients during treatment for possible clinical complications due to myelosuppression. • Tumor Lysis Syndrome: During treatment, monitor blood chemistries and manage promptly. Treat as clinically indicated. • Hypersensitivity: Monitor patients for hypersensitivity reactions and manage as clinically indicated.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Cardiomyopathy • Secondary Malignancies • Severe Local Tissue Necrosis with Extravasation • Severe Myelosuppression • Tumor Lysis Syndrome • Hypersensitivity Most common adverse reactions (≥30%) are infection, nausea/vomiting, alopecia, abdominal pain/diarrhea, hemorrhage, mucositis, dermatologic, mental status changes, and pulmonary disorders.
Source: US FDA prescribing information
Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Store and dispense in the original carton until time of use to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
6 presentations of Idarubicin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Idarubicin 10 mg/10 mL injectionIntravenous Cold chainGeneric name | — | US FDA | Available on request |
| Idarubicin 20 mg/20 mL injectionIntravenous Cold chainGeneric name | — | US FDA | Available on request |
| Idarubicin 5 mg/5 mL injectionIntravenous Cold chainGeneric name | — | US FDA | Available on request |
| Idamycin PFS 10 mg/10 mL injectionIntravenous Cold chain | Pfizer Laboratories | US FDA | Available on request |
| Idamycin PFS 20 mg/20 mL injectionIntravenous Cold chain | Pfizer Laboratories | US FDA | Available on request |
| Idamycin PFS 5 mg/5 mL injectionIntravenous Cold chain | Pfizer Laboratories | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 27 September 1990 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Idarubicin in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 6 presentations of Idarubicin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Idarubicin, including Idamycin PFS.
Yes. The US FDA first approved Idarubicin on 27 September 1990, according to Drugs@FDA.
At least one listed presentation of Idarubicin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Idarubicin is classified under ATC code L01DB06 (Idarubicin).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.