Darunavir Pregnancy and Breastfeeding Warnings

Darunavir is also known as: Prezista

Darunavir Pregnancy Warnings

An Antiretroviral Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnant women exposed to darunavir. Physicians are encouraged to register patients by calling 1-800-258-4263 (USA).

Darunavir has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of embryotoxicity or teratogenicity. There are no controlled data in human pregnancy. Darunavir is only recommended for use during pregnancy when benefit outweighs risk.

Darunavir Breastfeeding Warnings

There are no data on the excretion of darunavir into human milk. Darunavir is secreted into the milk of lactating rats. The effects in the nursing infant are unknown. The U.S. Public Health Service Centers for Disease Control and Prevention advise HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child who may not yet be infected. The manufacturer recommends that due to the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should not breast-feed while taking darunavir.

A reduction in pup body weight gain was observed in pups exposed to darunavir alone or in combination with ritonavir during lactation in the rat pre- and postnatal development study.

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