Pregnancy: There are no adequate and well-controlled studies of irinotecan in pregnant women. Irinotecan is teratogenic in rats and rabbits (see Pharmacology: Toxicology: Preclinical safety data under Actions). Irinotecan may cause fetal harm when administered to a pregnant woman.
Women of childbearing potential should not be started on irinotecan until pregnancy is excluded. Pregnancy should be avoided if either partner is receiving irinotecan.
Due to the potential for genotoxicity, advise female patients of reproductive potential to use highly effective contraception during treatment and for 6 months after the last dose of irinotecan.
Due to the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of irinotecan.
Lactation: The available data are limited to one patient only. Irinotecan and its active metabolite SN-38 were measured in the milk of one lactating patient. The effect on newborn/infants is unknown. Because of the potential for serious adverse reactions in nursing infants, it is recommended not to breastfeed when receiving therapy with irinotecan.
In rats, radioactivity appeared in the milk within 5 minutes of intravenous administration of radiolabeled irinotecan and was concentrated up to 65-fold at 4 hours after administration relative to plasma concentrations.