Gemcitabine Pregnancy and Breastfeeding Warnings

Gemcitabine is also known as: Gemzar

Gemcitabine Pregnancy Warnings

When administered to mice at approximately 1/200th of the human dose, gemcitabine was embryotoxic, causing fetal malformations including cleft palate and incomplete ossification. Embryotoxicity was characterized by decreased fetal viability, reduced live litter size, and developmental delays. When administered to rabbits at approximately 1/600th of the human dose, gemcitabine was fetotoxic, causing fetal malformation including fused pulmonary artery and absence of gallbladder. When administered by the intraperitoneal route to male mice at approximately 1/700th of the human dose, gemcitabine had an effect on fertility with moderate to severe hypospermatogenesis, decreased fertility and decreased implantations.

Gemcitabine has been assigned to pregnancy category D by the FDA. The drug may cause fetal harm when administered to a pregnant woman. Animal studies have revealed evidence of embryotoxicity and fetotoxicity. Studies in male animals have revealed evidence of hypospermatogenesis, decreased fertility, and decreased implantations. There are no controlled data in human pregnancy. Gemcitabine should only be given during pregnancy when there are no alternatives and benefit outweighs risk. If the drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be apprised of the potential hazard to the fetus.

Gemcitabine Breastfeeding Warnings

There are no data on the excretion of gemcitabine into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions 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.

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