Xpreza 100 Use In Pregnancy & Lactation

Pregnancy: Teratogenic Effects: Pregnancy Category D.
Azacitidine for injection may cause fetal harm when administered to a pregnant woman. Early embryo toxicity studies in mice revealed a 44% frequency of intrauterine embryonal death (increased resorption) after a single IP (intraperitoneal) injection of 6 mg/m² (approximately 8% of the recommended human daily dose on a mg/m² basis) azacitidine on gestation day 10. 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).
In rats, azacitidine was clearly embryotoxic when given IP on gestation days 4-8 (Post implantation) at a dose of 6 mg/m² (approximately 8% of the recommended human daily dose on a mg/m² basis), although treatment in the preimplantation period (on gestation days 1-3) had no adverse effect on the embryos. Azacitidine caused multiple fetal abnormalities in rats after single IP dose of 3 to 12 mg/m² (approximately 8% the recommended human daily dose mg/m² daily dose on a mg/m² basis) given on gestation days 9, 10, 11 or 12. In this study azacitidine caused fetal death when administered at 3-12 mg/m² on gestation days 9 and 10; average live animals per litter was reduced to 9% of control at the highest dose on gestation day 9. Fetal anomalies included: CNS anomalies (exencephaly/encephalocele), limb anomalies (micromelia, club foot, syndactyly, oligodactyly), and others (micrognathia, gastroschisis, edema, and rib abnormalities). There are no adequate and well-controlled studies in pregnant women using azacitidine. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the foetus.
Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with azacitidine.
Fertility: Men should be advised to not father a child while receiving treatment with azacitidine. (See Precautions for discussion of premating effects of azacitidine exposure on male fertility and embryonic viability.)