Women of childbearing potential: Women of childbearing potential must be advised not to get pregnant during therapy.
Pregnancy: There are no data from the use of gefitinib in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. Gefitinib should not be used during pregnancy unless clearly necessary.
Breast-feeding: It is not known whether gefitinib is secreted in human milk. Gefitinib and metabolites of gefitinib accumulated in milk of lactating rats (see Pharmacology: Toxicology: Preclinical safety data under Actions). Gefitinib is contraindicated during breast-feeding and therefore breast-feeding must be discontinued while receiving gefitinib therapy (see Contraindications).