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Decitabine Pregnancy and Breastfeeding Warnings

Brand names: Dacogen

Medically reviewed by Drugs.com. Last updated on May 18, 2023.

Decitabine Pregnancy Warnings

Animal studies at lower that comparable human therapeutic doses revealed reduced fetal survival and fetal weight. Supernumerary ribs, fused vertebrae and ribs, cleft palate, vertebral defects, hind-limb defects, digital defects of fore- and hind-limbs, exophthalmia, exencephaly, and cleft palate were observed. There are no controlled data in human 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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: Not assigned.

Risk Summary: This drug was teratogenic in animal studies at as low as 2% of the comparable human dose.

Comments:
-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 be advised to use effective contraception and avoid becoming pregnant while being treated with this drug. The period following therapy when it is safe to become pregnant is unknown.
-Men should use effective contraception and be advised to not father a child while receiving this drug, and for 3 months following the last dose.

See references

Decitabine Breastfeeding Warnings

UK: Use is contraindicated.
US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Decitabine (decitabine). Accord Healthcare Inc. 2017.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Decitabine (decitabine). Accord Healthcare Inc. 2017.

Further information

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

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