Abacavir/lamivudine Pregnancy and Breast Feeding Warnings
Abacavir/lamivudine is also known as: Epzicom
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Abacavir/Lamivudine while you are pregnant. Abacavir/Lamivudine is found in breast milk. Do not breast feed while taking Abacavir/Lamivudine . Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Abacavir/Lamivudine to the baby.
Abacavir/lamivudine Pregnancy Warnings
Abacavir-lamivudine has been assigned to pregnancy category C by the FDA. High-dose studies with abacavir in rats have revealed evidence of embryonic and fetal toxicity, including developmental toxicity, fetal anasarca, skeletal malformations, and increased incidence of stillbirth. High-dose studies with lamivudine in rats have failed to reveal evidence of fetotoxicity. However, there is some indication of early embryolethality in rabbit studies using doses proportional to normal human dosages. There are no controlled data in human pregnancy. Abacavir-lamivudine is only recommended for use during pregnancy when benefit outweighs risk. To monitor fetal outcomes of pregnant women exposed to abacavir-lamivudine, an Antiretroviral Pregnancy Registry has been established. Healthcare providers are encouraged to register patients by calling 1-800-258-4263 (USA).
Abacavir/lamivudine Lactation Warnings
There are no data on the excretion of abacavir into human milk. It is excreted into the milk of lactating rats. Lamivudine is excreted into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, mothers should not breast-feed during abacavir-lamivudine therapy. 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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