Idarucizumab Pregnancy and Breastfeeding Warnings
Medically reviewed by Drugs.com. Last updated on Dec 19, 2022.
Idarucizumab is also known as: Praxbind
Idarucizumab Pregnancy Warnings
Animal studies have not been reported. 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.
Use is recommended only if clearly needed and the benefit outweighs the risk.
US FDA pregnancy category: Not assigned
Risk Summary: Safety has not been established during pregnancy.
Idarucizumab Breastfeeding Warnings
US: Caution is recommended and benefit should outweigh risk.
UK: The manufacturer makes no recommendation regarding use during lactation.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: The effects in the nursing infant are unknown.
See also
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- "Product Information. Praxbind (idarucizumab)." Boehringer Ingelheim (2016):
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- "Product Information. Praxbind (idarucizumab)." Boehringer Ingelheim (2016):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
