Finished product reference
Idarubicin Hydrochloride
Injection, Solution · Parenteral · 1 mg/1mL · 5 mL
- List code
- 51983
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.
What it is and how it works
Mechanism of Action 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.
Indications
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.
Dosage and administration (summary)
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. ( 2.3 , 8.6 ) • Hepatic Impairment: Assess hepatic function prior to therapy. Avoid or reduce dosage in hepatic impairment.
Contraindications
None. None.
Warnings and precautions
• 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. • Renal Impairment : Assess renal function prior to and during treatment.
Pregnancy
Pregnancy Risk Summary Based on findings from animal reproduction studies and its mechanism of action, IDAMYCIN PFS can cause fetal harm when administered to a pregnant woman . There are no available data on the use of IDAMYCIN PFS in pregnant women to evaluate for a drug-associated risk.
Storage and supply
How Supplied IDAMYCIN PFS (idarubicin hydrochloride) injection is a clear, orange-red, aqueous, preservative-free solution available as follows: Single-dose Cytosafe™ vials : Unit of Sale Concentration NDC 0013-2576-91 Carton of 1 Single-dose Vial 5 mg/5 mL (1 mg/mL) NDC 0013-2586-91 Carton of 1 Single-dose Vial 10 mg/10 mL (1 mg/mL) NDC 0013-2596-…
Source: Idarubicin Hydrochloride (Idamycin Pfs) — US FDA prescribing information, 2026-04-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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