Idarubicin Hydrochloride (3 brand names, 2 dosage forms, 1 route)
Available dosage forms: SOLUTION, POWDER.
Routes of administration: INTRAVENOUS.
Brand Names
- IDAMYCIN
- IDAMYCIN PFS
- IDARUBICIN HYDROCHLORIDE
Boxed Warning
• 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. Assess left ventricular cardiac function prior to initiation of IDAMYCIN PFS and during and after treatment [see Warnings and Precautions (5.1)]. • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including IDAMYCIN PFS [see Warnings and Precautions (5.2)]. • Extravasation and Tissue Necrosis: Extravasation of IDAMYCIN PFS during administration can result in local tissue injury and necrosis. Immediately terminate the infusion of IDAMYCIN PFS and institute the recommended management procedures [see Dosage and Administration (2.6) and Warnings and Precautions (5.3) ].
Indications and Usage
IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen.
Contraindications
None.
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: •Cardiomyopathy [see Warnings and Precautions (5.1)] •Secondary Malignancies [see Warnings and Precautions (5.2)] •Severe Local Tissue Necrosis with Extravasation [see Warnings and Precautions (5.3)] •Severe Myelosuppression [see Warnings and Precautions (5.4)] •Tumor Lysis Syndrome [see Warnings and Precautions (5.5)] •Hypersensitivity [see Warnings and Precautions (5.6)]
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.
Overdosage
There is no known antidote to idarubicin hydrochloride. Two cases of fatal overdosage in patients receiving therapy for AML have been reported. The doses were 135 mg/m2 over 3 days and 45 mg/m2 of idarubicin hydrochloride and 90 mg/m2 of daunorubicin over a three-day period. Based on multicompartment and extravascular distribution, tissue binding, and low unbound fraction available in plasma, hemodialysis or peritoneal dialysis are unlikely to significantly reduce exposure during an overdosage.