Gemita Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category D.
Gemcitabine is cautiously administered to a pregnant woman. There are no studies of gemcitabine in pregnant women. Gemcitabine at doses of 1.5 mg/kg/day in mice (about 1/200 the recommended human dose on a mg/m² basis) is embryotoxic causing fetal malformations (cleft palate, incomplete ossification). Gemcitabine at doses of 0.1 mg/kg/day in rabbits (about 1/600 the recommended human dose on a mg/m² basis) is fetotoxic causing fetal malformations (fused pulmonary artery, absence of gall bladder). Embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays. The patient should be apprised of the potential hazard to the fetus if gemcitabine is used during pregnancy, or if the patient becomes pregnant while taking gemcitabine.
Nursing Mothers: The excretion kinetics of gemcitabine or its metabolites in human milk is unknown. Because of the potential for serious adverse reactions from gemcitabine 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.