Women of childbearing potential / Contraception in males and females: Women of childbearing potential and men must use effective contraception during and up to 3 months after treatment.
Pregnancy: There are no adequate data on the use of azacitidine in pregnant women. Studies in mice have shown Reproductive toxicity. The potential risk for humans is unknown. Based on results from animal studies and its mechanism of action, azacitidine should not be used during pregnancy, especially during the first trimester, unless clearly necessary. The advantages of treatment should be weighed against the possible risk for the foetus in every individual case.
Breast-feeding: It is not known whether azacitidine or its metabolites are excreted in human milk. Due to the potential serious adverse reactions in the nursing child, breast-feeding is contraindicated during azacitidine therapy.
Fertility: There are no human data on the effect of azacitidine on fertility. In animals, adverse reactions with azacitidine use on male fertility have been documented. Men should be advised not to father a child while receiving treatment and must use effective contraception during and up to 3 months after treatment. Before starting treatment, male patients should be advised to seek counselling on sperm storage.