Atazanavir Pregnancy and Breastfeeding Warnings

Atazanavir is also known as: Reyataz

Atazanavir Pregnancy Warnings

An Antiretroviral Pregnancy Registry (APR) has been established to monitor maternal-fetal outcomes of pregnant women exposed to atazanavir. Healthcare providers are encouraged to register patients by calling 1-800-258-4263 (USA). As of January 2010, the APR has received prospective reports of 635 pregnancies (425, 160, and 50 first, second, and third trimester exposures, respectively). Birth defects occurred in 9 of 393 live births with first trimester exposure and 5 of 212 live births with second or third trimester exposure. The background rate of birth defects among pregnant women in the US reference population is 2.7%. There was no association between atazanavir and overall birth defects observed in the APR. In one clinical study, atazanavir plus ritonavir was given with lamivudine and zidovudine to 41 HIV-infected pregnant women during the second or third trimester. Less than 50 copies/mL HIV RNA was achieved at time of delivery by 38 of the 39 patients completing the study. Hyperbilirubinemia (total bilirubin 2.6 times the upper limit of normal or greater) was reported in 6 of 20 women on atazanavir 300 mg plus ritonavir 100 mg and 13 of 21 women on atazanavir 400 mg plus ritonavir 100 mg. Lactic acidosis was not reported during this study. Atazanavir drug levels in fetal umbilical cord blood were about 12% to 19% of maternal levels. All 40 infants (83% were Black or African American) born to 40 HIV-infected pregnant women were negative for HIV-1 DNA at delivery and/or during the first 6 months postpartum. Antiretroviral prophylactic therapy containing zidovudine was administered to all 40 infants. During this study, the neonates did not develop severe hyperbilirubinemia (total bilirubin greater than 20 mg/dL) or acute or chronic bilirubin encephalopathy. Bilirubin levels of 4 mg/dL or greater were reported within the first day of life in 10 of 36 infants (6 were at least 38 weeks gestation and 4 were less than 38 weeks gestation). Three of the 38 infants who had glucose samples collected the first day of life had values of less than 40 mg/dL that could not be attributed to maternal glucose intolerance, difficult delivery, or sepsis. The manufacturer recommends that all infants, including newborns exposed to atazanavir in utero, be monitored for severe hyperbilirubinemia during the first few days of life.

Atazanavir has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of teratogenicity at maternal doses producing systemic drug exposure levels 0.7 (in rabbits) or 1.2 (in rats) times those at the human clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir). Atazanavir has been evaluated in a limited number of women during pregnancy and postpartum. Available human data suggest the risk of major birth defects overall compared to the background rate is not increased by atazanavir; however, human studies cannot rule out the possibility of harm. Hyperbilirubinemia has been reported frequently during atazanavir therapy and it is not known whether maternal use would lead to neonatal kernicterus. Hyperlactatemia and lactic acidosis syndrome (in some cases fatal) have been reported in pregnant women taking atazanavir in combination with nucleoside analogs. Atazanavir should not be administered without ritonavir during pregnancy and should only be given to pregnant women with HIV-1 strains susceptible to atazanavir. Atazanavir is only recommended for use during pregnancy when benefit outweighs risk.

Atazanavir Breastfeeding Warnings

There are no data on the excretion of atazanavir into human milk. 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 yet be infected. The manufacturer recommends that due to the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should not breast-feed while taking atazanavir.

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