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Raltegravir Pregnancy and Breastfeeding Warnings

Raltegravir is also known as: Isentress

Raltegravir Pregnancy Warnings

Animal studies have revealed evidence of placental transfer resulting in fetal plasma levels about 1.5- and 2.5-fold greater than maternal plasma levels at 1 hour and 24 hours postdose, respectively, at a maternal dose of 600 mg/kg/day. There are no controlled data in human pregnancy. A pregnancy registry has been established to monitor maternal-fetal outcomes of pregnant women exposed to raltegravir. Physicians are encouraged to register patients by calling 1-800-258-4263 (USA). 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.

FDA pregnancy category: C Raltegravir should be used during pregnancy only if the benefit outweighs the risk to the fetus.

Raltegravir Breastfeeding Warnings

Breastfeeding is not recommended during use of raltegravir. 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-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.

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