Dacogen

Dacogen Use In Pregnancy & Lactation

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Full Prescribing Info
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 DACOGEN. The time period following treatment with DACOGEN where it is safe to become pregnant is unknown. There are no adequate data on the use of DACOGEN in pregnant women. Studies have shown that decitabine is teratogenic in rats and mice (See Pharmacology: Toxicology: Non-clinical Information under Actions). The potential risk for humans is unknown. Based on results from animal studies and its mechanism of action, DACOGEN should not be used during pregnancy, unless clearly necessary. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving DACOGEN, 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 DACOGEN, and for 3 months following completion of treatment (see Pharmacology: Toxicology: Non-clinical Information under Actions).
Fertility: Female patients of childbearing potential should be advised to seek consultation regarding oocyte cryopreservation prior to initiation of treatment with DACOGEN. Because of the possibility of infertility as a consequence of DACOGEN 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. DACOGEN is contraindicated during lactation; therefore if treatment with DACOGEN is required, breast-feeding must be discontinued (see Contraindications).
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