Abacavir / lamivudine Pregnancy and Breastfeeding Warnings

Abacavir / lamivudine is also known as: Epzicom

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 Breastfeeding 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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