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Azacitidine Pregnancy and Breastfeeding Warnings

Azacitidine is also known as: Onureg, Vidaza

Medically reviewed by Drugs.com. Last updated on Oct 19, 2020.

Azacitidine Pregnancy Warnings

Use is contraindicated.

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 can cause fetal harm when administered to a pregnant woman. It was teratogenic and caused embryofetal lethality in animals at doses lower than the equivalent recommended human daily dose.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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.
-Women of childbearing potential should use effective contraception during therapy and for 3 months after.
-Men with female partners of reproductive potential should use effective contraception during therapy and for 3 months after.

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

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.

See references

Azacitidine Breastfeeding Warnings

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It might be possible to breastfeed safely during
intermittent therapy with an appropriate period of breastfeeding abstinence. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.

Use is contraindicated.

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

Comments:
-Due to serious toxicity (severe target organ toxicity, genotoxicity, and carcinogenicity) observed in animal studies and the potential for serious adverse effects on the nursing child, breastfeeding should be discontinued.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Vidaza (azacitidine)." Celgene Corporation, Summit, NJ.

References for breastfeeding information

  1. "Product Information. Vidaza (azacitidine)." Celgene Corporation, Summit, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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