Redtibin Use In Pregnancy & Lactation

Contraception in males and females: Women of childbearing potential must 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. Men should use effective contraceptive measures and be advised to not father a child while receiving Decitabine, and for 3 months following completion of treatment.
The use of decitabine with hormonal contraceptives has not been studied.
Pregnancy: There are no adequate data on the use of Decitabine in pregnant women. Studies have shown that decitabine is teratogenic in rats and mice. The potential risk for humans is unknown. Based on results from animal studies and its mechanism of action, decitabine should not be used during pregnancy and in women of childbearing potential not using effective contraception. If decitabine is used during pregnancy, or if a patient becomes pregnant while receiving this medicinal product, the patient should be apprised of the potential hazard to the foetus.
Lactation: 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.
Fertility: No human data on the effect of decitabine on fertility are available. In non-clinical animal studies, decitabine alters male fertility and is mutagenic. Because of the possibility of infertility as a consequence of Decitabine therapy, men should seek advice on conservation of sperm and female patients of childbearing potential should seek consultation regarding oocyte cryopreservation prior to initiation of treatment with decitabine.