Entecavir Pregnancy and Breastfeeding Warnings

Entecavir is also known as: Baraclude

Entecavir Pregnancy Warnings

Entecavir has been assigned to pregnancy category C by the FDA. Animal studies have revealed maternal toxicity, embryofetal toxicity, skeletal malformations, and/or decreased fetal weights with doses ranging from 883 to 3100 times those in humans. There are no controlled data in human pregnancy. Entecavir should only be given during pregnancy if clearly needed and when the potential benefits outweigh the risks.

A pregnancy registry has been established to monitor fetal outcomes of pregnant women exposed to entecavir. Healthcare providers are encouraged to register patients by calling 1-800-258-4263 (USA).

Entecavir Breastfeeding Warnings

There are no data on the excretion of entecavir into human milk. It is excreted into rat milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue entecavir, taking into account the importance of entecavir to the mother. In addition, mothers coinfected with HIV should not breast-feed their infants due to the risk of transmission of HIV via breast milk.

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