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Emtricitabine / tenofovir Pregnancy and Breastfeeding Warnings

Emtricitabine / tenofovir is also known as: AccessPak for HIV PEP Basic, Truvada

Emtricitabine / tenofovir Pregnancy Warnings

Animal studies have failed to reveal evidence of embryofetal toxicity or teratogenicity. There are no controlled data in human pregnancy. However, emtricitabine-tenofovir has been evaluated in a limited number of women during pregnancy and postpartum. Available human data suggest emtricitabine-tenofovir does not increase risk of major birth defects overall compared to background rate. To monitor fetal outcomes of pregnant women exposed to emtricitabine-tenofovir, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to register patients by calling 1-800-258-4263 (USA). As of July 2011, the APR has received prospective reports of 764 and 1219 exposures to emtricitabine- and tenofovir-containing regimens, respectively, in the first trimester, 321 and 455 exposures, respectively, in second trimester, and 140 and 257 exposures, respectively, in the third trimester. Birth defects occurred in 18 of 764 (2.4%) live births for emtricitabine-containing regimens and 27 of 1219 (2.2%) live births for tenofovir-containing regimens with first trimester exposure and 10 of 461 (2.2%) live births for emtricitabine-containing regimens and 15 of 712 (2.1%) live births for tenofovir-containing regimens with second or third trimester exposure. Among pregnant women in the U.S. reference population, the background rate of birth defects is 2.7%. There was no association between emtricitabine or tenofovir and overall birth defects observed in the APR. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

FDA pregnancy category: B HIV: Emtricitabine-tenofovir should be used during pregnancy only if clearly needed. Preexposure Prophylaxis: If an uninfected individual becomes pregnant while using emtricitabine-tenofovir, continued use of emtricitabine-tenofovir should be carefully considered, taking into account the potential increased risk of HIV-1 infection during pregnancy.

Emtricitabine / tenofovir Breastfeeding Warnings

Because the risks of low level exposure to emtricitabine and tenofovir to infants are unknown, the manufacturer recommends that mothers should not breastfeed if they are receiving emtricitabine-tenofovir, whether for treatment or to reduce the risk of acquiring HIV-1. Samples of breast milk obtained from 5 HIV-1 infected women showed that emtricitabine is secreted in human milk. Breastfeeding infants whose mothers are being treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in such infants are unknown. Samples of breast milk obtained from 5 HIV-1 infected mothers showed that tenofovir is secreted in human milk. Tenofovir-associated risks, including the risk of viral resistance to tenofovir, in infants breastfed by mothers being treated with tenofovir are unknown.

Use of emtricitabine-tenofovir is not recommended. Excreted into human milk: Yes Excreted into animal milk: Yes Comments: -The effects in the nursing infant are unknown. -The US Centers for Disease Control and Prevention and the American Academy of Pediatrics advise HIV-1 infected women not to breastfeed to avoid postnatal transmission of HIV-1 to a child who may not yet be infected.

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