Use in Pregnancy: Gemcitabine HCl can cause fetal harm when administered to a pregnant woman.
Gemcitabine HCl has been shown to cause malformations and embryotoxicity in mice and rabbits.
Pregnant women or women of childbearing potential should be advised to avoid becoming pregnant during therapy with gemcitabine HCl.
Use in Nursing Mothers: It is not known whether gemcitabine HCl or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from gemcitabine HCl in nursing infants, the mother should be warned and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother and the potential risk to the infant.