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Cobicistat Pregnancy and Breastfeeding Warnings

Cobicistat is also known as: Tybost

Cobicistat Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Comments: The manufacturer product information for atazanavir, darunavir, and other antiretroviral drugs should be consulted.

Animal studies have failed to reveal evidence of teratogenicity, embryofetal toxicity, or an effect on reproductive function. 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

AU TGA pregnancy category B1: 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 have not shown 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.

See references

Cobicistat Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal 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.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. 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."
  4. "Product Information. Tybost (cobicistat)." Gilead Sciences, Foster City, CA.

References for breastfeeding information

  1. "Product Information. Tybost (cobicistat)." Gilead Sciences, Foster City, CA.
  2. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. National Institute 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/PerinatalGL.pdf." ([2011 Sep 14]):
  3. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  4. 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."
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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