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Coagulation factor Xa Pregnancy and Breastfeeding Warnings

Brand names: Andexxa

Medically reviewed by Drugs.com. Last updated on Aug 16, 2023.

Coagulation factor Xa Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: Use is not recommended.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Risk Summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-The effects of this drug on human fertility are unknown.

Animal studies have not been reported. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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

Coagulation factor Xa Breastfeeding Warnings

This drug is a large protein molecule with a molecular weight of about 40,000. Its amount in milk is likely to be very low, and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract.

Caution is recommended.
-According to some authorities: Breastfeeding is not recommended during use of this drug.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for this drug and potential adverse effects on the infant.

See references

References for pregnancy information

  1. Product Information. Andexxa (coagulation factor Xa). Portola Pharmaceuticals. 2022.
  2. Product Information. Andexxa (coagulation factor Xa). AstraZeneca Pty Ltd. 2023.
  3. Product Information. Ondexxya (coagulation factor Xa). AstraZeneca UK Ltd. 2023.

References for breastfeeding information

  1. Product Information. Andexxa (coagulation factor Xa). Portola Pharmaceuticals. 2022.
  2. Product Information. Andexxa (coagulation factor Xa). AstraZeneca Pty Ltd. 2023.
  3. Product Information. Ondexxya (coagulation factor Xa). AstraZeneca UK Ltd. 2023.

Further information

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