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Idarucizumab Pregnancy and Breastfeeding Warnings

Idarucizumab is also known as: Praxbind

Medically reviewed on Jan 22, 2018

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.

See references

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 references

References for pregnancy information

  1. "Product Information. Praxbind (idaruCIZUMAB)." Boehringer Ingelheim, Ridgefield, CT.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Praxbind (idaruCIZUMAB)." Boehringer Ingelheim, Ridgefield, CT.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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