Adefovir Pregnancy and Breastfeeding Warnings

Adefovir is also known as: Hepsera

Adefovir Pregnancy Warnings

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

Adefovir dipivoxil has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of embryotoxicity or teratogenicity. There are no controlled data in human pregnancy. Adefovir dipivoxil is only recommended for use during pregnancy when benefit outweighs risk. There are no data concerning adefovir's effect on mother-to-infant hepatitis B virus transmission. Appropriate infant immunization is recommended to prevent neonatal acquisition of the virus.

Adefovir Breastfeeding Warnings

There are no data on the excretion of adefovir dipivoxil into human 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 the drug, taking into account the importance of the drug 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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