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Nevirapine Pregnancy and Breastfeeding Warnings

Nevirapine is also known as: Viramune, Viramune XR

Nevirapine Pregnancy Warnings

The Antiretroviral Pregnancy Registry has found no increased risk of birth defects after nevirapine exposure during the first trimester. The prevalence of birth defects following nevirapine exposure during the first trimester is similar to that seen in the general population. Severe and sometimes fatal hepatotoxicity has been reported in pregnant women receiving long-term nevirapine therapy as part of a combination antiretroviral regimen. Women, especially those with CD4+ counts greater than 250 cells/mm3, have a greater risk of developing hepatotoxicity. It is not known whether pregnancy increases this risk. Close monitoring for clinical symptoms and of hepatic transaminases is recommended, especially during the first 18 weeks of nevirapine treatment. The U.S. Department of Health and Human Services (DHHS) Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission states that nevirapine should be used as a component of a combination regimen in pregnant antiretroviral naive women with CD4+ counts greater than 250 cells/mm3 who are initiating antiretroviral therapy for the purpose of preventing perinatal HIV transmission only if the benefit clearly outweighs the risk. Zidovudine is considered the drug of choice for preventing perinatal HIV transmission during pregnancy. The DHHS Panel no longer recommends intrapartum single dose nevirapine for HIV-infected women in labor who have not received antepartum antiretroviral therapy. To monitor maternal-fetal outcomes of pregnant women exposed to nevirapine, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263 (USA).

Nevirapine has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal evidence of teratogenicity but did show impaired fertility and decreased fetal weight in female rats receiving the drug in amounts equivalent to and 50% greater than the usual doses recommended for humans, respectively. There are no controlled data in human pregnancy. Nevirapine is only recommended for use during pregnancy when benefit outweighs risk.

Nevirapine Breastfeeding Warnings

Nevirapine is excreted into human milk. The manufacturer advises that breast-feeding be discontinued in women who are receiving nevirapine. In addition, HIV-infected mothers should not breast-feed their infants due to the risk of transmission of HIV via breast milk.

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