There are no data from the use of IRESSA in pregnant or breast-feeding women. Studies in animals have shown reproductive toxicity. Animal studies also indicate that gefitinib and certain metabolites pass into rats breast-milk (see Pharmacology: Toxicology: Pre-clinical Safety Data Relevant to the Prescriber under Actions).
Women of childbearing potential must be advised to avoid becoming pregnant, and breast-feeding mothers must be recommended to discontinue nursing while receiving IRESSA therapy.