Hepavance Use In Pregnancy & Lactation

Pregnancy Category C: There are no adequate and well-controlled studies of HEPAVANCE in pregnant women. Because animal reproduction studies are not always predictive of human response, HEPAVANCE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: There are no studies in pregnant women and no data on the effect of HEPAVANCE on transmission of HBV from mother to infant. Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
Nursing Mothers: It is not known whether HEPAVANCE is excreted into human milk; however, entecavir is excreted into the milk of rats. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from HEPAVANCE, a decision should be made to discontinue nursing or to discontinue HEPAVANCE taking into consideration the importance of continued hepatitis B therapy to the mother and the known benefits of breastfeeding.