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Efavirenz / emtricitabine / tenofovir Pregnancy and Breastfeeding Warnings

Efavirenz / emtricitabine / tenofovir is also known as: Atripla

Efavirenz / emtricitabine / tenofovir Pregnancy Warnings

Animal studies have revealed evidence of fetal harm with efavirenz. Efavirenz crosses the placenta in animals and produces fetal blood levels similar to maternal blood levels. Efavirenz may cause fetal harm when used during the first trimester. There are no controlled data in human pregnancy. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to prospectively register patients. Information is available at www.apregistry.com. As of July 2010, the APR had received reports of 792 pregnancies exposed to efavirenz-containing regimens, 718 of which were first trimester exposures. Birth defects were observed in 17 of 604 live births with first trimester exposure and 2 of 69 live births with second or third trimester exposure. One of these prospective reports with first trimester exposure was a neural tube defect. Also, a single case of anophthalmia has been prospectively reported with first trimester efavirenz exposure; however, this case included severe oblique facial clefts and amniotic banding, a known association with anophthalmia. There have been 6 cases of findings consistent with neural tube defects (including meningomyelocele) retrospectively reported in infants of mothers with first trimester efavirenz exposure. Multiple defects (Dandy-Walker syndrome) in a fetus from a spontaneous abortion and neural tube defects in a fetus from a pregnancy terminated during the second trimester have also been reported. Both mothers had first trimester exposure to efavirenz-containing regimens. Causality could not be clearly established in any of these cases. The manufacturer recommends avoiding pregnancy during efavirenz/emtricitabine/tenofovir therapy. Barrier contraception must always be used in combination with other methods of contraception (e.g., hormonal) during use of this drug. Use of adequate contraception for 12 weeks after discontinuing the drug is recommended. Women of childbearing age should undergo pregnancy testing before starting efavirenz/emtricitabine/tenofovir and should be advised to notify their physician if they become pregnant during therapy. Patients should be advised of the potential harm to the fetus if they become pregnant while taking efavirenz/emtricitabine/tenofovir or if it is used during the first trimester. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: D Efavirenz/emtricitabine/tenofovir should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus. Comments: Effective contraception is recommended during therapy and for 12 weeks after the drug is stopped.

Efavirenz / emtricitabine / tenofovir Breastfeeding Warnings

Breast milk samples from 5 HIV-1 infected women showed emtricitabine is secreted in human milk. Infants breastfed by mothers treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in such infants are unknown. Breast milk samples from 5 HIV-1 infected mothers showed tenofovir is secreted in human milk. The impact of this exposure in infants breastfed by mothers treated with tenofovir is unknown. Since the risks of infant exposure to emtricitabine and tenofovir are unknown and due to the potential for HIV-1 transmission, the manufacturer states that mothers should not breastfeed if they are taking efavirenz/emtricitabine/tenofovir.

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

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