Caxeta Use In Pregnancy & Lactation

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 administered to pregnant women. In reported 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.
Lactation: It is not known whether capecitabine is excreted in human milk. No studies have been reported to assess the impact of capecitabine on milk production or its presence in human breast milk. In a reported study of single oral administration of capecitabine to lactating mice, a significant amount of capecitabine metabolites was detected in the milk. As the potential for harm to the nursing infant is unknown, breastfeeding should be discontinued during treatment with capecitabine and for 2 weeks after the final dose.