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Atazanavir / cobicistat Pregnancy and Breastfeeding Warnings

Atazanavir / cobicistat is also known as: Evotaz

Atazanavir / cobicistat Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity with atazanavir at maternal doses producing systemic drug exposure levels 0.7 (rabbits) or 1.2 (rats) times those at the human clinical dose (atazanavir 300 mg/day boosted with ritonavir 100 mg/day); at an exposure level causing maternal toxicity, body weight loss or weight gain suppression was observed in rat offspring. Animal studies have failed to reveal evidence of teratogenicity, embryofetal toxicity, or an effect on reproductive function with cobicistat. Atazanavir/ritonavir has been evaluated in a limited number of women during pregnancy and postpartum. Available data suggest atazanavir does not increase risk of major birth defects overall (compared with background rate); however, human studies cannot rule out the possibility of harm. For cobicistat and atazanavir-cobicistat, there are no controlled data in human pregnancy. Symptomatic hyperlactatemia and lactic acidosis syndrome (in some cases fatal) have been reported in pregnant women using atazanavir in combination with nucleoside analogs, which are known to have greater risk of lactic acidosis. Hyperbilirubinemia has been reported frequently during atazanavir therapy; it is not known whether maternal use would lead to neonatal kernicterus. All infants (including newborns exposed to atazanavir in utero) should be monitored for severe hyperbilirubinemia during the first few days of life. 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 had received prospective reports of 635 exposures to atazanavir-containing regimens (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. 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 the benefit outweighs the risk to the fetus; this drug should not be used in therapy-experienced patients taking an H2-receptor antagonist and/or tenofovir during the second and third trimesters. US FDA pregnancy category: B Comments: The manufacturer product information for atazanavir should be consulted for information regarding its use with ritonavir during pregnancy.

See references

Atazanavir / cobicistat Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, alternative therapy is recommended. Excreted into human milk: Yes (atazanavir); Unknown (cobicistat) Excreted into animal milk: Yes (cobicistat) 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 atazanavir (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 atazanavir.

See references

References for pregnancy information

  1. "Product Information. Reyataz (atazanavir)." Bristol-Myers Squibb, Princeton, NJ.
  2. "Product Information. Evotaz (atazanavir-cobicistat)." Bristol-Myers Squibb, Princeton, NJ.
  3. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. National Institutes of Health "Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Available from: URL: http://aidsinfo.nih.gov/contentfiles/lvguidelines/perina" ([2014 Mar 28 ]):

References for breastfeeding information

  1. "Product Information. Evotaz (atazanavir-cobicistat)." Bristol-Myers Squibb, Princeton, NJ.
  2. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. National Institutes of Health "Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Available from: URL: http://aidsinfo.nih.gov/contentfiles/lvguidelines/perina" ([2014 Mar 28 ]):
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6

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