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Enfuvirtide Pregnancy and Breastfeeding Warnings

Enfuvirtide is also known as: Fuzeon

Enfuvirtide Pregnancy Warnings

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).

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.

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

References for pregnancy information

  1. "Product Information. Fuzeon (enfuvirtide)." Roche Laboratories, Nutley, NJ.
  2. Perinatal HIV Guidelines Working Group "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. Available from: URL:" ([2008 Jul 8]):

References for breastfeeding information

  1. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  2. "Product Information. Fuzeon (enfuvirtide)." Roche Laboratories, Nutley, NJ.
  3. 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:" ([2011 Sep 14]):

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