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Pregnancy: There are no adequate or well controlled studies reported in pregnant women using erlotinib. Studies in animals have reported some reproductive toxicity. The potential risk for humans is unknown. Women of childbearing potential must 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. Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the fetus.
Lactation: It is not reported whether erlotinib is excreted in human milk. Because of the potential harm to the infant, mothers should be advised against breastfeeding while receiving erlotinib.
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