pharmacopeia
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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. 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.

Mechanism of action

Sourced from openFDA

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.

TopoisomeraseTopoisomerase 2

Indications

Sourced from openFDA
  • 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.ICD-10: C95.90

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

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. (2.1) • IDAMYCIN PFS can be given as part of a combination regimen with other chemotherapeutic drugs. (2.1) • 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. ( 2.4 , 8.7 ) See full prescribing information for preparation and administration instructions. (2.5 , 2.6) 2.1 Recommended Dosage Administer IDAMYCIN PFS 12 mg/m 2 intravenously over 10 to 15 minutes on days 1, 2, and 3 of induction in combination with cytarabine. The cytarabine may be given as 100 mg/m 2 by continuous intravenous infusion daily for 7 days or as cytarabine 25 mg/m 2 intravenous bolus followed by cytarabine 200 mg/m 2 continuous intravenous infusion daily for 5 days. If a response is not achieved with the first induction cycle, a second induction cycle may be administered. Other dosage regimens may be used for a second induction cycle. Individualize the dose and dosing schedule of IDAMYCIN PFS based on the specific regimen administered, disease state, response to treatment, and patient risk factors.

Warnings & precautions

Sourced from openFDA

• 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. (5.4) • Tumor Lysis Syndrome : During treatment, monitor blood chemistries and manage promptly. Treat as clinically indicated. (5.5) • Hypersensitivity : Monitor patients for hypersensitivity reactions and manage as clinically indicated. (5.6) • Renal Impairment : Assess renal function prior to and during treatment. Reduce the dose in patients on dialysis or those with GFR <30 mL/min. ( 2.3 , 5.7 , 8.6 ) • Hepatic Impairment : Obtain liver tests prior to and during therapy. Reduce dose in patients with serum bilirubin levels of 2.6 to 5 mg/dL. Avoid use in patients with serum bilirubin greater than 5 mg/dL. ( 2.4 , 5.8 , 8.7 ) • Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.9 , 8.1 , 8.3 ) 5.1 Cardiomyopathy IDAMYCIN PFS can cause myocardial damage, including left ventricular failure, or congestive heart failure (CHF). In pediatric patients, anthracycline-induced cardiomyopathy included impaired left ventricular systolic performance, reduced contractility, congestive heart failure, or death. Cardiomyopathy may develop during treatment with IDAMYCIN PFS or up to several years after completion of treatment.

Adverse reactions

Sourced from openFDA

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) ] Most common adverse reactions (≥30%) are infection, nausea/vomiting, alopecia, abdominal pain/diarrhea, hemorrhage, mucositis, dermatologic, mental status changes, and pulmonary disorders. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials and Postmarketing Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of IDAMYCIN PFS in combination with cytarabine has been evaluated in four controlled clinical studies with 823 patients with AML randomized to receive idarubicin hydrochloride (n=401) or daunorubicin (n=422) [see Clinical Studies (14) ] . Southeastern Cancer Study Group (SEG) Table 3 below lists the adverse reactions that occurred in patients with AML who received idarubicin hydrochloride in the Southeastern Cancer Study Group (SEG) study.

Use in specific populations

Sourced from openFDA

• Lactation : Advise not to breastfeed. (8.2) • Infertility : May impair fertility. (8.3) 8.1 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 [see Warnings and Precautions (5.9) ] . There are no available data on the use of IDAMYCIN PFS in pregnant women to evaluate for a drug-associated risk. Idarubicin hydrochloride was embryotoxic and teratogenic in rats at doses of 1.2 mg/m 2 /day or 0.1 times the human dose. Idarubicin hydrochloride was embryotoxic but not teratogenic in rabbits at doses of 2.4 mg/m 2 /day or 0.2 times the human dose [see Data ] . Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Idarubicin hydrochloride was embryotoxic and teratogenic in the rat at a dose of 1.2 mg/m 2 /day or 0.1 times the human dose, which was not maternally toxic. Idarubicin hydrochloride was embryotoxic but not teratogenic in the rabbit even at a dose of 2.4 mg/m 2 /day or 0.2 times the human dose, which was maternally toxic.

Pharmacokinetics

Sourced from openFDA
Metabolism
Idarubicin hydrochloride pharmacokinetics were determined in adult leukemia patients with normal renal and hepatic function following intravenous administration of idarubicin hydrochloride 10 to 12 mg/m 2 daily for 3 to 4 days as a single agent or combined with cytarabine. Accumulation is predicted to be 1.7-fold for idarubicin hydrochloride and 2.3-fold for idarubicinol following multiple idarubicin hydrochloride dosing.

Overdosage

Sourced from openFDA

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/m 2 over 3 days and 45 mg/m 2 of idarubicin hydrochloride and 90 mg/m 2 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.

Approval history

Sourced from openFDA
  • Feb 17, 1997NDANDA050734Pfizer
  • May 1, 2002ANDAANDA065036Meitheal
  • Dec 14, 2006ANDAANDA065275Hikma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,084 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Myelosuppression16615%
  2. 2Febrile Neutropenia14413%
  3. 3Pyrexia867.9%
  4. 4Off Label Use666.1%
  5. 5Pneumonia575.3%
  6. 6White Blood Cell Count Decreased565.2%
  7. 7Neutropenia504.6%
  8. 8Infection484.4%
  9. 9Platelet Count Decreased484.4%
  10. 10Neutrophil Count Decreased434.0%
  11. 11Nausea403.7%
  12. 12Death393.6%
  13. 13Sepsis393.6%
  14. 14Acute Myeloid Leukaemia383.5%
  15. 15Drug Ineffective353.2%

Literature

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Recent PubMed references pinned to Idarubicin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 351 ClinicalTrials.gov registrations naming Idarubicin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Idarubicin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CBR3CPIC D (provisional)
  • HAS3CPIC D (provisional)

Frequently asked questions

How does Idarubicin work?
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.
What is Idarubicin used for?
According to FDA labeling, Idarubicin carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Idarubicin?
Idarubicin is classified as Anthracyclines and related substances, Anthracycline Topoisomerase Inhibitor, Topoisomerase 2 Inhibitors, Topoisomerase Inhibitors, Decreased DNA Integrity, Decreased Hematopoiesis, Decreased RNA Integrity.
What are the brand names for Idarubicin?
Idarubicin is marketed under brand names including Idamycin.
What are the contraindications for Idarubicin?
Idarubicin labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for idarubicin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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