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Lepirudin Pregnancy and Breastfeeding Warnings

Lepirudin is also known as: Refludan

Lepirudin Pregnancy Warnings

Lepirudin has been assigned to FDA pregnancy category B by the FDA. Animal data failed to reveal evidence of teratogenicity or fetotoxicity after doses 1.2 and 2.4 times the maximum recommended daily human dosage (controlled for body size). Limited data revealed evidence of increased maternal mortality with these doses. There are no adequate or controlled data from human pregnancy. Lepirudin should be given during pregnancy only when need has been clearly established.

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Lepirudin Breastfeeding Warnings

There are no data on the excretion of lepirudin into human milk. The manufacturer recommends that due to the potential for serious adverse events in nursing infants, a decision should be made whether to discontinue nursing or lepirudin therapy, taking into account the importance of the drug to the woman.

See references

References for pregnancy information

  1. "Product Information. Refludan (lepirudin)." Hoechst Marion-Roussel Inc, Kansas City, MO.

References for breastfeeding information

  1. "Product Information. Refludan (lepirudin)." Hoechst Marion-Roussel Inc, Kansas City, MO.

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