Skip to main content

Amprenavir Pregnancy and Breastfeeding Warnings

Brand names: Agenerase

Amprenavir Pregnancy Warnings

Amprenavir has been assigned to pregnancy category C by the FDA. High-dose animal studies have revealed evidence of an increased incidence of abortions, skeletal variations due to incomplete ossification of bones, thymic elongation, and reduced body weights. There are no controlled data in human pregnancy. Amprenavir should only be given during pregnancy when benefit outweighs risk. The oral solution of amprenavir is contraindicated during pregnancy due to the potential risk of toxicity to the fetus from the high propylene glycol content.

An Antiretroviral Pregnancy Registry has been to monitor maternal-fetal outcome of amprenavir exposures during pregnancy. To register patients, physicians should call 1-800-258-4263 (USA).

See references

Amprenavir Breastfeeding Warnings

There are no data on the excretion of amprenavir into human milk. It is excreted into rat milk. 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. (2001) "Product Information. Agenerase (amprenavir)." Glaxo Wellcome
  2. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents -- A Working Group of the Office of AIDS Research Advisory Council (OARAC) (2006) Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf
  3. 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. (2001) "Product Information. Agenerase (amprenavir)." Glaxo Wellcome
  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

Further information

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

Medical Disclaimer