Efavirenz/emtricitabine/tenofovir Pregnancy and Breast Feeding Warnings
Efavirenz/emtricitabine/tenofovir is also known as: Atripla
Overview
Efavirenz/Emtricitabine/Tenofovir may cause harm to the fetus. Do not become pregnant while you take Efavirenz/Emtricitabine/Tenofovir and for 12 weeks after you stop taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Efavirenz/Emtricitabine/Tenofovir while you are pregnant. It is not known if Efavirenz/Emtricitabine/Tenofovir is found in breast milk. Do not breast-feed while taking Efavirenz/Emtricitabine/Tenofovir . Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Efavirenz/Emtricitabine/Tenofovir to the baby.
Efavirenz/emtricitabine/tenofovir Pregnancy Warnings
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 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 2007, the Antiretroviral Pregnancy Registry has received reports of 373 pregnancies, 359 of which were first trimester exposures. Birth defects were observed in 7 of 295 live births with first trimester exposure and 1 of 26 live births with second/third trimester exposure, none of which were neural tube defects. In addition, 5 cases of findings consistent with neural tube defects have been 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 should be used in combination with other methods of contraception (e.g., hormonal). 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 800-258-4263 (USA).
Efavirenz/emtricitabine/tenofovir Lactation Warnings
There are no data on the excretion of efavirenz, emtricitabine, or tenofovir into human milk. Efavirenz and tenofovir are both excreted into the milk of lactating rats. The effects in the nursing infant are unknown. The U.S. Public Health Service Centers for Disease Control and Prevention advise HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child who may not be infected.
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