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Fosamprenavir Pregnancy and Breastfeeding Warnings

Fosamprenavir is also known as: Lexiva, Telzir

Fosamprenavir Pregnancy Warnings

During a retrospective study, fosamprenavir-based highly active antiretroviral therapy was well-tolerated in 9 pregnant women and most achieved favorable immunologic and virologic responses. Good birth outcomes and no significant side effects were reported in infants. No mother-to-child transmission of HIV was detected. An Antiretroviral Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnant women exposed to fosamprenavir. Physicians are encouraged to register patients by calling 1-800-258-4263 (USA).

Fosamprenavir has been assigned to pregnancy category C by the FDA. Administration of fosamprenavir to pregnant rats and rabbits produced no major effects on embryofetal development. However, the incidence of abortion was increased in rabbits that were administered fosamprenavir. There are no controlled data in human pregnancy. Fosamprenavir is only recommended for use during pregnancy when benefit outweighs risk.

See references

Fosamprenavir Breastfeeding Warnings

There are no data on the excretion of amprenavir into human milk following administration of fosamprenavir. Amprenavir is excreted into the milk of lactating rats. The manufacturer recommends that due to the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should not breast-feed while taking fosamprenavir. The U.S. Public Health Service Centers for Disease Control and Prevention advise HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child who may not yet be infected.

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References for pregnancy information

  1. Martorell C, Theroux E, Bermudez A, Garb J, Kronschnabel D, Oie K "Safety and Efficacy of Fosamprenavir in Human Immunodeficiency Virus-infected Pregnant Women." Pediatr Infect Dis J 29 (2010): 985
  2. "Product Information. Lexiva (fosamprenavir)." GlaxoSmithKline, Research Triangle Park, NC.
  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: http://aidsinfo.nih.gov/contentfiles/PerinatalGL.pdf." ([2011 Sep 14]):

References for breastfeeding information

  1. "Product Information. Lexiva (fosamprenavir)." GlaxoSmithKline, Research Triangle Park, NC.
  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

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