Skip to main content

Prothrombin complex Pregnancy and Breastfeeding Warnings

Brand names: Balfaxar, Kcentra

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

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.

See references

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 references

References for pregnancy information

  1. Product Information. Kcentra (prothrombin complex). CSL Behring LLC. 2013.

References for breastfeeding information

  1. Product Information. Kcentra (prothrombin complex). CSL Behring LLC. 2013.

Further information

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