Dolutegravir Pregnancy and Breastfeeding Warnings

Dolutegravir is also known as: Tivicay

Dolutegravir Pregnancy Warnings

Animal studies have failed to reveal evidence of impaired fertility or fetal harm. Dolutegravir was shown to cross the placenta in animal studies. 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 B1: 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 not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Dolutegravir should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B1 US FDA pregnancy category: B

Dolutegravir Breastfeeding Warnings

Breastfeeding is not recommended during use of dolutegravir. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.

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