Use in Pregnancy: Pregnancy Category D.
Imatinib can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. Advise women of childbearing potential to avoid becoming pregnant while taking imatinib. Instruct sexually active women taking imatinib to use adequate contraception. If this drug is used during pregnancy or if the patient becomes pregnant while taking imatinib, apprise the patient hazard to the fetus.
Use in Lactation: Imatinib and its metabolites are excreted in human milk. Based on data from 3 breast-feeding women taking imatinib, the milk to plasma ratio is approximately 0.5 for amanitins and approximately 0.9 for the active metabolite. Considering the combined concentration of imatinib and active metabolite, a breast-fed infant could receive up to 10% of the maternal therapeutic dose based on body weight. Because of the potential for serious adverse reactions in breast-feeding infants, decide whether to discontinue breast-feeding or the drug, taking into account the importance of the drug to the mother.