Pemxcel Use In Pregnancy & Lactation

Use in pregnancy: Teratogenic Effects: Pregnancy Category D: Based on its mechanism of action, pemetrexed can cause fetal harm when administered to a pregnant woman. Pemetrexed administered intraperitoneally to mice during organogenesis was embryotoxic, fetotoxic and teratogenic in mice at >1/833rd the recommended human dose. If pemetrexed is used during pregnancy, or if the patient becomes pregnant while taking Pemxcel, the patients should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Women should be advised to use effective contraceptive measures to prevent pregnancy during treatment with pemetrexed.
Use in lactation: It is not known whether pemetrexed or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from pemetrexed, a decision should be made to discontinue nursing or discontinue Pemxcel taking into account the importance of Pemxcel for the mother.