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Idamycin Pfs (IDARUBICIN HYDROCHLORIDE)
Idarubicin hydrochloride exerts its effects by forming DNA complexes, inhibiting nucleic acid synthesis, blocking topoisomerase II, and generating DNA-damaging free radicals.
Idamycin PFS (idarubicin hydrochloride) is a small molecule anthracycline topoisomerase inhibitor originally developed by Pfizer. It targets DNA topoisomerase 2-alpha, an enzyme essential for DNA replication and repair. Idarubicin is FDA-approved for treating acute myeloid leukemia and acute promyelocytic leukemia. As an off-patent medication, it is available from multiple generic manufacturers. Key safety considerations include its potential for cardiotoxicity and myelosuppression.
At a glance
| Generic name | IDARUBICIN HYDROCHLORIDE |
|---|---|
| Sponsor | Pfizer |
| Drug class | Anthracycline Topoisomerase Inhibitor |
| Target | DNA, topoisomerase II |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1990 |
Mechanism of action
Idarubicin hydrochloride works by interfering with DNA in cancer cells. It forms complexes with DNA, which prevents the synthesis of nucleic acids and blocks the activity of topoisomerase II, an enzyme crucial for DNA replication. Additionally, it produces free radicals that damage DNA, leading to cell death.
Approved indications
- Acute myeloid leukemia, disease
- Acute promyelocytic leukemia, FAB M3
Boxed warnings
- 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. 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) ] . WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS See full prescribing information for complete boxed warning. • Cardiomyopathy: Myocardial damage leading to congestive heart failure can occur with IDAMYCIN PFS. Assess left ventricular cardiac function prior to initiation of IDAMYCIN PFS and during and after treatment. (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. (5.2) • Extravasation of IDAMYCIN PFS during administration can result in local tissue injury and necrosis. Immediately discontinue the IDAMYCIN PFS infusion if extravasation occurs. ( 2.6 , 5.3 )
Common side effects
- Infection
- Nausea Vomiting
- Hair Loss
- Abdominal Cramps/Diarrhea
- Hemorrhage
- Mucositis
- Dermatologic
- Mental Status
- Pulmonary-Clinical
- Fever (not elsewhere classified)
- Headache
- Cardiac-Clinical
Key clinical trials
- Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1 (PHASE3)
- Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia (PHASE1)
- BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia (PHASE2)
- CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics (PHASE2)
- VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML (PHASE3)
- Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML) (PHASE2)
- Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML (PHASE3)
- A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Idamycin Pfs CI brief — competitive landscape report
- Idamycin Pfs updates RSS · CI watch RSS