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. A pregnancy registry has been established to monitor maternal-fetal outcomes of pregnant women with HIV exposed to dolutegravir and other antiretrovirals. Healthcare providers are encouraged to register patients by calling 1-800-258-4263 (USA). 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.

FDA pregnancy category: B Dolutegravir should be used during pregnancy only if clearly needed.

Dolutegravir Breastfeeding Warnings

Due to the potential for HIV transmission and the potential for adverse reactions in nursing infants, mothers should not breastfeed if taking dolutegravir. Excreted into human milk: Unknown Excreted into animal milk: Yes The US Centers for Disease Control and Prevention and the American Academy of Pediatrics advise HIV-1-infected women not to breastfeed to avoid postnatal transmission of HIV-1 to a child who may not yet be infected.

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