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Cobicistat / darunavir Pregnancy and Breastfeeding Warnings

Cobicistat / darunavir is also known as: Prezcobix

Cobicistat / darunavir Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity, embryofetal toxicity, or an effect on reproductive function and fertility. There are no controlled data in human pregnancy. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk. US FDA pregnancy category: C

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Cobicistat / darunavir 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: Unknown (cobicistat, darunavir) Excreted into animal milk: Yes (cobicistat, darunavir) 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.

A transient reduction in pup body weight gain was observed in pups exposed to darunavir (with or without ritonavir) during lactation in a rat pre- and postnatal development study.

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References for pregnancy information

  1. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  2. "Product Information. Prezcobix (cobicistat-darunavir)." Janssen Pharmaceuticals, Titusville, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  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. "Product Information. Prezcobix (cobicistat-darunavir)." Janssen Pharmaceuticals, Titusville, NJ.
  5. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  6. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

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