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Pregnant Women: There are no adequate and well-controlled studies in pregnant women using gefitinib tablets. Women of childbearing potential must be advised to avoid becoming pregnant. If gefitinib tablets are used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus or potential risk for loss of the pregnancy. Gefitinib tablets may cause fetal harm when administered to a pregnant woman (see Pharmacology: Toxicology: Reproduction & Teratology under Actions).
Nursing Women: It is not known whether gefitinib is excreted in human milk, however this is documented to occur in pre-clinical testing (see Pharmacology: Toxicology: Reproduction & Teratology under Actions). Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should be advised against breast-feeding while receiving gefitinib therapy.
