Azacitidine Pregnancy and Breastfeeding Warnings

Brand names: Onureg, Vidaza

Medically reviewed by Drugs.com. Last updated on Oct 9, 2023.

Azacitidine Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: Use is contraindicated.
-According to some authorities: Use is not recommended especially during the first trimester of pregnancy, unless clearly needed.

AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action and findings in animals, this drug may cause fetal harm. No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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 harm to the fetus.
-If a patient or partner becomes pregnant while taking this drug, treatment benefits should be weighed against potential fetal risks in each case.
-Women of childbearing potential should use effective contraception during therapy and for 6 months after the last dose.
-Men with female partners of reproductive potential should use effective contraception during therapy and for 3 months after the last dose.
-Advice males and females of reproductive potential to seek counseling on cryo-conserving either sperm or ovum prior to starting therapy.

Animal studies have revealed teratogenicity and embryofetal lethality at doses lower than the recommended human dose. Animal studies revealed increased fetal resorption, developmental brain abnormalities, central nervous system and limb anomalies, fetal abnormalities, and fetal death. Animal data also showed decreased fertility and other fertility-related adverse effects including decreased weight of the testes and epididymides, decreased sperm counts, decreased pregnancy rates, increase in abnormal embryos, and increased pre- and post-implantation loss. There are no controlled data in human pregnancy.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

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Azacitidine Breastfeeding Warnings

In an animal tumorigenicity study, this drug increased the incidence of testicular tumors when dosed twice weekly at 15 or 60 mg/m2 (approximately 20 to 80% of the recommended human daily dose on a mg/m2 basis).
Due to the serious toxicity (severe target organ toxicity, genotoxicity, and carcinogenicity) observed in animal studies, breastfeeding should be discontinued during this drug therapy.

Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-Because of the potential of this drug to cause serious adverse effects on the nursing child, advise patients to avoid breastfeeding during treatment and for 1 week after the last dose.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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