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Erlotinib Pregnancy and Breastfeeding Warnings

Erlotinib is also known as: Tarceva

Erlotinib Pregnancy Warnings

Erlotinib has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of maternal toxicity with associated embryo/fetal lethality and abortion. In animal studies where the drug was given prior to mating through the first week of pregnancy, an increase in early resorptions which resulted in a decrease in the number of live fetuses has been reported. There are no controlled data in human pregnancy. Women of childbearing potential should be advised to avoid pregnancy while on erlotinib. Adequate contraceptive methods should be used during therapy, and for at least 2 weeks after completing therapy. If erlotinib is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Erlotinib Breastfeeding Warnings

There are no data on the excretion of erlotinib into human milk. Because many drugs are excreted in human milk and because the effects of erlotinib on infants have not been studied, women should not breast-feed while receiving erlotinib therapy.

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