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Pregnancy: There are no adequate data from the use of gemcitabine in pregnant patients. Studies in animals have shown reproductive toxicity. 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.
Lactation: It is now known whether gemcitabine is excreted in human milk and adverse events on the suckling child cannot be excluded. Breast-feeding must be discontinued during gemcitabine therapy.
Fertility: In fertility studies, gemcitabine caused hypospermatogenesis in male mice. Therefore, men being treated with gemcitabine are advised not to father 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.
