Nevirapine Pregnancy and Breast Feeding Warnings
Nevirapine is also known as: Viramune
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nevirapine while you are pregnant. Nevirapine is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Nevirapine to the baby.
Nevirapine Pregnancy Warnings
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. However, 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 any 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 Perinatal HIV Guidelines Working Group of the U.S. Public Health Service recommends cautious use of nevirapine in pregnant antiretroviral naive women if antiretroviral therapy is being initiated for the purpose of preventing perinatal HIV transmission, but therapy is not required based on their CD4+ counts. Zidovudine is considered the drug of choice for preventing perinatal HIV transmission during pregnancy. Intrapartum single dose nevirapine with intravenous zidovudine may be considered for women without antepartum antiretroviral therapy to prevent perinatal HIV transmission. Nevirapine is only recommended for use during pregnancy when benefit outweighs risk.
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 Lactation 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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