Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential: given that the potential risks to the developing foetus are unknown, women of childbearing potential should use effective contraception.

Pregnancy: there are no adequate data from the use of entecavir in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is unknown. Baraclude should not be used during pregnancy unless clearly necessary. There are no data on the effect of entecavir on transmission of HBV from mother to newborn infant.
Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.

Breast-feeding: it is unknown whether entecavir is excreted in human milk. Available toxicological data in animals have shown excretion of entecavir in milk (for details see section 5.3). A risk to the infants cannot be excluded. Breast-feeding should be discontinued during treatment with Baraclude.

Fertility: toxicology studies in animals administered entecavir have shown no evidence of impaired fertility (see section 5.3).