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Azacitidine Pregnancy and Breastfeeding Warnings

Azacitidine is also known as: Vidaza

Azacitidine Pregnancy Warnings

AU: Use is contraindicated during pregnancy. UK, US: Use is not recommended during pregnancy, especially during the first trimester, unless clearly necessary. AU TGA pregnancy category: X US FDA pregnancy category: Not Assigned Comments: -This drug can cause fetal harm based on its mechanism of action and findings from animal studies. -Prior to treatment initiation, verify the pregnancy status in females of reproductive potential and advise male patients to seek counseling on sperm storage. -Advise females of reproductive potential and male patients to use effective contraception during and up to 3 months after the last dose.

Animal studies have revealed teratogenicity and embryofetal lethality at doses lower than the recommended human dose. Adverse effects observed in animals included 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.

See references

Azacitidine Breastfeeding Warnings

UK: Use is contraindicated during breastfeeding. AU, US: Use is not recommended during breastfeeding. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant or on milk production are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." 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

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