Entecavir Pregnancy and Breastfeeding Warnings
Entecavir is also known as: Baraclude
Entecavir Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: Use of effective contraception has been recommended.
Animal studies have failed to reveal evidence of teratogenicity. Maternal and embryofetal toxicity were not seen with oral doses ranging from 28 to 212 times the highest human exposure (1 mg/day); maternal toxicity, embryofetal toxicity, skeletal malformations, and/or decreased fetal weights were observed with exposures ranging from 883 to 3100 times those in humans. There are no controlled data in human pregnancy. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Entecavir Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes
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