Prothrombin complex Pregnancy and Breastfeeding Warnings
Brand names: Balfaxar, Kcentra
Medically reviewed by Drugs.com. Last updated on Feb 27, 2025.
Prothrombin complex Pregnancy Warnings
FDA pregnancy category: C
Prothrombin complex concentrate is not recommended unless clearly needed.
Animal reproduction studies have not been conducted. It is not known whether prothrombin complex concentrate can cause fetal harm when administered to a pregnant woman or if it may affect reproduction. Prothrombin complex concentrate should be prescribed for a pregnant woman only if clearly needed.
FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Prothrombin complex Breastfeeding Warnings
Use only if clearly needed.
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
The effects in the nursing infant are unknown.
See also
References for pregnancy information
- (2013) "Product Information. Kcentra (prothrombin complex)." CSL Behring LLC
References for breastfeeding information
- (2013) "Product Information. Kcentra (prothrombin complex)." CSL Behring LLC
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.