There are no adequate data from 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.

Nursing Mothers

It is unknown whether azacitidine/metabolites are excreted in human milk.

Due to the potential serious adverse reactions in the nursing child, breast-feeding is contraindicated during azacitidine therapy.

Carcinogenesis, Mutagenesis and Fertility

Women of childbearing potential / Contraception in males and females

Women of childbearing potential and men have to use effective contraception during and up to 3 months after treatment.


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.

Effects on Ability to Drive and Use Machines

Azacitidine has minor or moderate influence on the ability to drive and use machines. Fatigue has been reported with the use of azacitidine. Therefore, caution is recommended when driving or operating machines.