Coagulation factor Xa Pregnancy and Breastfeeding Warnings
Coagulation factor Xa is also known as: Andexxa
Medically reviewed by Drugs.com. Last updated on Apr 17, 2019.
Coagulation factor Xa Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned
Risk Summary: Insufficient data exists in pregnant women to inform patients of associated risks.
Animal studies have not been reported. There are no controlled data in human pregnancy.
Safety and effectiveness during labor and delivery have not been evaluated.
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.
Coagulation factor Xa Breastfeeding Warnings
Benefits and risks should be considered.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: The effects in the nursing infant are unknown.
References for pregnancy information
- "Product Information. Andexxa (coagulation factor Xa)." Portola Pharmaceuticals, South San Francisco, CA.
References for breastfeeding information
- "Product Information. Andexxa (coagulation factor Xa)." Portola Pharmaceuticals, South San Francisco, CA.
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Further information
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