Atazanavir Pregnancy and Breastfeeding Warnings
Atazanavir is also known as: Reyataz
Atazanavir Pregnancy Warnings
Animal studies have failed to reveal evidence of teratogenicity at maternal doses producing systemic drug exposure levels 0.7 (rabbits) or 1.2 (rats) times those at the human clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir). This drug has been evaluated in a limited number of women during pregnancy and postpartum. Available data suggest risk of major birth defects overall (compared to background rate) is not increased by this drug; however, human studies cannot rule out the possibility of harm. Hyperbilirubinemia has been reported frequently during drug 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 using this drug in combination with nucleoside analogs. 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. For additional information: apregistry.com 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 at least 2.6 times the upper limit of normal) 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. Drug levels in fetal umbilical cord blood were about 12% to 19% of maternal levels. All 40 infants (83% Black/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 at least 4 mg/dL 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 this drug in utero, be monitored for severe hyperbilirubinemia during the first few days of life. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US 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.
This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: B2 US FDA pregnancy category: B Comments: -This drug should not be administered without ritonavir during pregnancy and postpartum. -This drug should only be used in pregnant women with HIV-1 strains susceptible to atazanavir.
Atazanavir Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, a different drug may be preferred. Excreted into human milk: Yes Comments: -The effects in the nursing infant are unknown. -The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected. -Local guidelines should be consulted if replacement feeding is not an option.
On postpartum days 5 and 14, samples of breast milk and plasma were obtained at 0, 2, 5, 8, and 24 hours postdose from 3 women taking this drug (dose not stated; 300 mg/day likely) as part of highly active antiretroviral therapy. Breast milk levels over 24 hours averaged 212 mcg/L on day 5 and 265 mcg/L on day 14. Peak breast milk levels averaged 419 mcg/L at 5 hours postdose. The breast milk to plasma ratio averaged 13% for this drug.
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