Azacord Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category D.
Azacitidine is teratogenic in animals. Developmental abnormalities in the brain have been detected in mice given azacitidine on or before gestation day 15 at doses of ~3-12 mg/m² (approximately 4%-16% the recommended human daily dose on a mg/m² basis). Azacitidine may cause fetal harm when administered to a pregnant woman. There are no adequate and well controlled studies with Azacitidine in pregnant women. Women of childbearing potential should be advised to avoid pregnancy during treatment with azacitidine. If this drug is used during pregnancy or if a patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Female partners of male patients receiving azacitidine should not become pregnant.
Nursing mothers: It is not known whether azacitidine or its metabolites are excreted in human milk. Because of the potential for tumorigenicity shown for azacitidine in animal studies and the potential for serious adverse reactions in nursing infants from azacitidine, a decision should be made to continue drug or not taking into consideration the importance of the drug to the mother.