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Bivalirudin Pregnancy and Breastfeeding Warnings

Brand names: Angiomax, Angiomax RTU

Medically reviewed by Drugs.com. Last updated on Mar 18, 2024.

Bivalirudin Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk Summary: There are no available data on use of this drug in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

Studies in rats and rabbits (1.6 and 3.2 times the maximum recommended human dose respectively) did not reveal evidence of fetal harm or impaired fertility. Animal studies using higher doses (5.4 the max human dose) showed litter sizes and live fetuses were reduced and also fetal skeletal variations. There are no studies during the perinatal period due to risk of hemorrhage during delivery. There are no controlled data in human pregnancy.

TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

See references

Bivalirudin Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-Studies in lactating female rats revealed no adverse developmental outcomes to the pups.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for treatment and any potential adverse effects on the breastfed infant.

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2016) "Product Information. Bivalirudin (bivalirudin)." Fresenius Kabi USA, LLC

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
  4. (2016) "Product Information. Bivalirudin (bivalirudin)." Fresenius Kabi USA, LLC

Further information

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

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