Pregnancy: 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. There are no adequate and well-controlled studies of irinotecan in pregnant women.
If the drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with irinotecan.
Lactation: 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. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued when receiving therapy with irinotecan.