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Caplacizumab Pregnancy and Breastfeeding Warnings

Caplacizumab is also known as: Cablivi

Medically reviewed by Drugs.com. Last updated on Mar 8, 2019.

Caplacizumab Pregnancy Warnings

Animal studies have failed to reveal evidence of adverse developmental outcomes. There are no controlled data in human pregnancy. However, there are potential risks of hemorrhage in the mother and fetus associated with use of this drug.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: Insufficient data exist to inform a drug-associated risk of major birth defects and miscarriage; however, there are potential risks of hemorrhage in the mother and fetus associated with use of this drug.

Comments:
-Pregnant women receiving this drug should be carefully monitored for evidence of excessive bleeding.
-This drug may increase the risk of bleeding in the fetus and neonate. Monitor neonates for bleeding.

See references

Caplacizumab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.

No information is available on the clinical use of this drug during breastfeeding. Because it is a large protein molecule the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.

See references

References for pregnancy information

  1. "Product Information. Cablivi (caplacizumab)." Genzyme Corporation, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Cablivi (caplacizumab)." Genzyme Corporation, Cambridge, MA.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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