Efavirenz / emtricitabine / tenofovir Pregnancy and Breastfeeding Warnings
Efavirenz / emtricitabine / tenofovir is also known as: Atripla
Efavirenz / emtricitabine / tenofovir Pregnancy Warnings
Efavirenz may cause fetal harm when administered during the first trimester. Efavirenz crosses the placenta in animals and produces fetal blood concentrations similar to maternal blood concentrations. Reproduction studies in monkeys given dosages yielding plasma drug concentrations similar to those in humans treated with normally recommended dosages have revealed evidence of teratogenicity, including anencephaly, unilateral anophthalmia, microphthalmia, and cleft palate. Increased fetal resorptions were reported in rats and no reproductive toxicity was reported in rabbits. As of July 2010, the Antiretroviral Pregnancy Registry has received reports of 792 pregnancies, 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 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 who had first trimester 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 treatment with efavirenz. Barrier contraception must always be used in combination with other methods of contraception (e.g., hormonal). Use of adequate contraception for 12 weeks following efavirenz discontinuation is recommended. Women of childbearing age should undergo pregnancy testing before initiating efavirenz therapy and be advised to notify their physician if they become pregnant during treatment. Patients should be advised of the potential harm to the fetus if they become pregnant while taking efavirenz or if it is administered during the first trimester. 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. An Antiretroviral Pregnancy Registry has been established to monitor maternal-fetal outcome of efavirenz exposures during pregnancy. To register patients, physicians may call 1-800-258-4263 (USA).
Efavirenz/emtricitabine/tenofovir has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of fetal harm with efavirenz. There are no controlled data in human pregnancy. Efavirenz/emtricitabine/tenofovir is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
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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