Pregnancy: Pregnancy category D.
There are no studies in pregnant women using Capecitabine; however, based on the pharmacological and toxicological properties of Capecitabine, it can be assumed that Capecitabine may cause fetal harm if administered to pregnant women. In reproductive toxicity studies in animals, capecitabine administration caused embryolethality and teratogenicity. These findings are expected effects of fluoropyrimidine derivatives. Capecitabine should be considered a potential human teratogen. Capecitabine should not be used during pregnancy. If Capecitabine is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient must be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Capecitabine.
Nursing Mothers: It is not known whether the drug is excreted in human milk. In a study of single oral administration of Capecitabine to lactating mice, a significant amount of capecitabine metabolites was detected in the milk. Nursing should be discontinued during Capecitabine treatment.