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/foetal lethality, (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.
Women of childbearing potential: Women of childbearing potential must be advised to avoid pregnancy while on ALVOCEVA. 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 foetus.
Breast-feeding: It is not known whether erlotinib is excreted in human milk. Because of the potential harm to the infant, mothers should be advised against breast-feeding while receiving ALVOCEVA.
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 (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.