Emtricitabine Pregnancy and Breast Feeding Warnings

Emtricitabine is also known as: Emtriva

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Emtricitabine while you are pregnant. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Emtricitabine to the baby.

Emtricitabine Pregnancy Warnings

Emtricitabine has been assigned to pregnancy category B by the FDA. The incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed with emtricitabine in mice at exposures approximately 60 fold higher and in rabbits at approximately 120 fold higher than human exposures at the recommended daily dose. There are no controlled data in human pregnancy. Emtricitabine should be used during pregnancy only if clearly needed. To monitor fetal outcomes of pregnant women exposed to emtricitabine, an antiretroviral Pregnancy Registry as been established. Healthcare providers are encouraged to register patients by calling 1-800-258-4263 (USA).

Emtricitabine Lactation Warnings

There are no data on the excretion of emtricitabine into human milk. HIV-infected mothers should not breast-feed their infants due to the risk of transmission of HIV via breast milk.

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