Fertility: In fertility studies gemcitabine caused hypospermatogenesis in male mice (see Pharmacology: Toxicology under Actions). Therefore, men being treated with gemcitabine are advised not to father a child during and up to 6 months after treatment and to seek further advice regarding cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with gemcitabine.
Use in Pregnancy: There are no adequate data from the use of gemcitabine in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology under Actions). Based on results from animal studies and the mechanism of action of gemcitabine, this substance should not be used during pregnancy unless clearly necessary. Women should be advised not to become pregnant during treatment with gemcitabine and to warn their attending physician immediately, should this occur after all.
Use in Lactation: It is not known whether gemcitabine is excreted in human milk and adverse effects on the suckling child cannot be excluded. Breast-feeding must be discontinued during gemcitabine therapy.