(idarubicin hydrochloride)
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/m2/day or 0.1 times the human dose. Idarubicin hydrochloride was embryotoxic but not teratogenic in rabbits at doses of 2.4 mg/m2/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.
Animal Data
Idarubicin hydrochloride was embryotoxic and teratogenic in the rat at a dose of 1.2 mg/m2/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/m2/day or 0.2 times the human dose, which was maternally toxic.
Risk Summary
There are no data on the presence of idarubicin hydrochloride or its metabolites in human milk, the effects on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, including myelosuppression, cardiac toxicity and malignancy, advise women not to breastfeed during treatment with IDAMYCIN PFS and for 14 days after the last dose.
Based on mechanism of action and findings in animals, IDAMYCIN PFS can cause fetal harm [see Use in Specific Populations (8.1)].
Pregnancy Testing
Verify the pregnancy status of female patients of reproductive potential prior to initiating therapy with IDAMYCIN PFS.
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with IDAMYCIN PFS and for 6.5 months after the last dose.
Males
Based on the genotoxicity potential, advise males with female partners of reproductive potential to use effective contraception during treatment with IDAMYCIN PFS and for 3.5 months after the last dose.
Infertility
Based on animal studies and mechanism of action, IDAMYCIN PFS may impair fertility in males and females of reproductive potential [see Nonclinical Toxicology (13.1)]. It is not known if these effects are reversible.
The safety and effectiveness of IDAMYCIN PFS in pediatric patients have not been established. Pediatric patients may be at greater risk for anthracycline-induced acute manifestations of cardiotoxicity or late cardiovascular dysfunction.
The safety and effectiveness of idarubicin hydrochloride were assessed but not established in two open label clinical studies in pediatric patients aged 1 to <17 years with leukemia and solid tumors. The pharmacokinetics of idarubicin hydrochloride in these pediatric patients were within range of that observed in adult patients given a similar dose based on body surface area.
Idarubicin hydrochloride and idarubicinol were detected in CSF samples obtained in these patients; the clinical relevance of these findings is unknown.
Patients over 60 years of age who were undergoing induction therapy experienced congestive heart failure, serious arrhythmias, chest pain, myocardial infarction, and asymptomatic declines in LVEF more frequently than younger patients [see Adverse Reactions (6.1)].
Reduce dosage of IDAMYCIN PFS in patients with GFR less than 30 mL/min and in patients on hemodialysis [see Dosage and Administration (2.3)]. Renal function should be evaluated prior to and during treatment with IDAMYCIN PFS.
The effect of renal impairment on idarubicin hydrochloride or idarubicinol pharmacokinetics is unknown [see Clinical Pharmacology (12.3)]. However, renal impairment can affect the disposition of idarubicin hydrochloride based on a mechanistic understanding of idarubicin hydrochloride elimination. Treatment was not given if creatinine serum levels exceeded 2 mg/dL in multiple clinical trials.
Reduce dosage of IDAMYCIN PFS in patients with serum bilirubin levels greater than 2.6 mg/dL and less than 5 mg/dL [see Dosage and Administration (2.4)]. Do not administer IDAMYICN PFS in patients with serum bilirubin levels greater than 5 mg/dL. Liver function should be evaluated prior to and during treatment with IDAMYCIN PFS.
The effect of hepatic impairment on idarubicin hydrochloride or idarubicinol pharmacokinetics is unknown [see Clinical Pharmacology (12.3)]. However, hepatic impairment can affect the disposition of idarubicin hydrochloride based on a mechanistic understanding of idarubicin hydrochloride elimination.
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