Decitex Use In Pregnancy & Lactation

Pregnancy: Women of childbearing potential should be advised to use effective contraceptive measures and avoid becoming pregnant while being treated with decitabine. The time period following treatment with decitabine where it is safe to become pregnant is unknown. There are no adequate data on the use of decitabine in pregnant women. Reported studies have shown that decitabine is teratogenic in rats and mice. The potential risk for humans is unknown. Based on reported results from animal studies and its mechanism of action, decitabine should not be used during pregnancy, unless clearly necessary. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving decitabine, the patient should be apprised of the potential hazard to the fetus.
Use in Males: Men should be advised to not father a child while receiving decitabine, and for 3 months following completion of treatment.
Fertility: Female patients of childbearing potential should be advised to seek consultation regarding oocyte cryopreservation prior to initiation of treatment with decitabine. Because of the possibility of infertility as a consequence of decitabine therapy, men should be advised to seek advice on conservation of sperm prior to any treatment.
Breast-feeding: It is not known whether decitabine or its metabolites are excreted in breast milk. Decitabine is contraindicated during lactation; therefore if treatment with decitabine is required, breast-feeding must be discontinued (see CONTRAINDICATIONS).