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Idarubicin Pregnancy and Breastfeeding Warnings

Idarubicin is also known as: Idamycin, Idamycin PFS

Idarubicin Pregnancy Warnings

Idarubicin has been assigned to pregnancy category D by the FDA. Animal data have revealed evidence of teratogenicity, embryotoxicity, testicular atrophy, and inhibition of spermatogenesis and sperm maturation. There is no conclusive information about idarubicin adversely affecting human fertility or causing teratogenesis. There are no adequate and well-controlled studies in pregnant women. If idarubicin is to be used during pregnancy, or if the patient becomes pregnant during therapy, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid pregnancy. Use of idarubicin during pregnancy is considered contraindicated.

A single case in which idarubicin was given during pregnancy has been reported. Data are available for other anthracyclines. A 26-year-old woman presented at 20 weeks' gestation with acute myelogenous leukemia (AML) received daunorubicin and cytarabine as induction therapy, but required retreatment after 3 weeks due to unequivocal evidence of persistence of acute leukemia. She received mitoxantrone and cytarabine as her second course of chemotherapy. Complete remission and a normal fetal growth rate were documented after a total of 60 days from the start of therapy. Due to the long period of time required to obtain remission, it was decided to consolidate therapy with idarubicin 10 mg/m2 (with cytarabine) at approximately 32 weeks' gestation. She tolerated the treatment well and was discharged only to return two days later complaining of abdominal pain and lack of fetal activity for six to eight hours. After ultrasonographic evidence of fetal death, labor was induced, and the patient delivered a stillborn fetus with no obvious congenital malformations weighing 2,200 grams. Autopsy permission was denied. Limited data have shown that it is possible to give a single very high dose cycle of chemotherapy for AML in younger women without compromising fertility.

Idarubicin Breastfeeding Warnings

There are no data on the excretion of idarubicin into human milk. Because many drugs are excreted into human milk and because the potential for serious adverse reactions in nursing infants from idarubicin, mothers should discontinue nursing prior to taking this drug.

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