Erlox Use In Pregnancy & Lactation

Pregnancy: There are no adequate data for the use of erlotinib in pregnant women. Studies in animals have shown no evidence of teratogenicity or abnormal parturition. However, an adverse effect on the pregnancy cannot be excluded as rat and rabbit studies have shown increased embryo/fetal lethality. The potential risk for humans is unknown.
Women of childbearing potential: 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.
Breast-feeding: It is not known whether erlotinib is excreted in human milk. No studies have been conducted to assess the impact of erlotinib on milk production or its presence in breast milk. As the potential harm to the nursing infant is unknown, mothers should be advised against breast-feeding while receiving Erlotinib and for at least 2 weeks after the final dose.
Fertility: Studies in animals have shown no evidence of impaired fertility. However, an adverse effect on the fertility cannot be excluded as animal studies have shown effects on reproductive parameters. The potential risk for humans is unknown.