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Maraviroc Pregnancy and Breastfeeding Warnings

Maraviroc is also known as: Selzentry

Medically reviewed on Nov 9, 2017

Maraviroc Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm at exposures 20-fold (rats) and 5-fold (rabbits) higher than human exposures. Pre-implantation loss occurred in rats exposed to maternotoxic doses. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

See references

Maraviroc 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: Unknown
Excreted into animal milk: Yes (extensively)

Comments:
-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.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Yost R, Pasquale TR, Sahloff EG "Maraviroc: A coreceptor CCR5 antagonist for management of HIV infection." Am J Health Syst Pharm 66 (2009): 715-26
  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 ]):
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Lieberman-Blum SS, Fung HB, Bandres JC "Maraviroc: A CCR5-receptor antagonist for the treatment of HIV-1 infection." Clin Ther 30 (2008): 1228-50
  6. "Product Information. Selzentry (maraviroc)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

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. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Selzentry (maraviroc)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  5. 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 -]):
  6. Lieberman-Blum SS, Fung HB, Bandres JC "Maraviroc: A CCR5-receptor antagonist for the treatment of HIV-1 infection." Clin Ther 30 (2008): 1228-50
  7. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  8. Yost R, Pasquale TR, Sahloff EG "Maraviroc: A coreceptor CCR5 antagonist for management of HIV infection." Am J Health Syst Pharm 66 (2009): 715-26

Further information

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

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