Citagem Use In Pregnancy & Lactation

Use in Pregnancy: Pregnancy Category D: Gemcitabine can cause fetal harm when administered to a pregnant woman. In pre-clinical studies in mice and rabbits, gemcitabine was teratogenic, embryotoxic and fetotoxic. There are no adequate and well-controlled studies of gemcitabine in pregnant women. Women of childbearing age receiving gemcitabine should be advised to avoid becoming pregnant. If gemcitabine is used during pregnancy, or if the patient becomes pregnant while receiving the drug, evaluate potential hazard to the fetus.
Use in Lactation: It is not known whether gemcitabine or its metabolites are excreted in human milk. However, studies in lactating rats have shown gemcitabine and/or its metabolites in the milk 10 minutes after an IV dose. Breastfeeding must be discontinued during gemcitabine therapy.