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Topotecan Pregnancy and Breastfeeding Warnings

Topotecan is also known as: Hycamtin

Topotecan Pregnancy Warnings

Topotecan has been assigned to pregnancy category D by the FDA. Animal data have revealed evidence of maternal toxicity, embryolethality, reduced fetal body weight, fetal resorption, microphthalmia, and pre-implant loss. Topotecan may cause fetal harm when administered to a pregnant woman. There are no controlled data in human pregnancy. Women who are receiving topotecan should be advised to avoid pregnancy. If topotecan is used during pregnancy, or if the patient becomes pregnant while receiving the drug, she should be advised of the potential hazard to the fetus.

Animal data have revealed evidence of embryolethality, fetotoxicity, and teratogenicity when administered during organogenesis.

Topotecan Breastfeeding Warnings

There are no data on the excretion of topotecan into human milk. The manufacturer states that topotecan should be discontinued when women are receiving topotecan.

Topotecan is excreted in high concentrations into the milk of rats. Lactating female rats given 4.72 mg/m2 IV (about twice the clinical dose on a mg/m2 basis) excreted topotecan into milk at concentrations up to 48-fold higher than those in plasma.

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