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Pregnancy: Pregnancy Category D.
Gefitinib may cause fetal harm when administered to a pregnant woman.
There are no adequate and well-controlled studies in pregnant women using Gefitinib. If Gefitinib is 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.
Nursing Mothers: It is not known whether Gefitinib is excreted in human milk.
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.
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