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Enfuvirtide Pregnancy and Breastfeeding Warnings

Brand names: Fuzeon

Medically reviewed by Drugs.com. Last updated on Jul 5, 2023.

Enfuvirtide Pregnancy Warnings

Enfuvirtide has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Enfuvirtide is only recommended for use during pregnancy when benefit outweighs risk.

An Antiretroviral Pregnancy Registry has been established to monitor maternal-fetal outcome of enfuvirtide exposures during pregnancy. To register patients, physicians should call 800-258-4263 (USA).

See references

Enfuvirtide Breastfeeding Warnings

There are no data on the excretion of enfuvirtide into human milk. Due to the potential for serious adverse reactions in nursing infants mothers should be advised not to breast-feed during enfuvirtide therapy. In addition, HIV-infected mothers should not breast-feed their infants due to the risk of transmission of HIV via breast milk.

See references

See also

References for pregnancy information

  1. (2003) "Product Information. Fuzeon (enfuvirtide)." Roche Laboratories
  2. Perinatal HIV Guidelines Working Group (2008) Public Health Service Task Force recommendations for use of antiretroviral drugs in pregnant HIV-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. http://aidsinfo.nih.gov/contentfiles/Perinata

References for breastfeeding information

  1. (2003) "Product Information. Fuzeon (enfuvirtide)." Roche Laboratories
  2. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. National Institute of Health (2012) 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. http://aidsinfo.nih.gov/contentfiles/PerinatalGL.pdf
  3. (2013) "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics, 131, p. 391-6

Further information

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