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Tipranavir Pregnancy and Breastfeeding Warnings

Tipranavir is also known as: Aptivus

Tipranavir Pregnancy Warnings

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

Tipranavir has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of fetotoxicity (reduced ossification and weight) and growth inhibition at approximately 0.8-fold human exposure of the recommended dose. There are no controlled data in human pregnancies. Tipranavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

See references

Tipranavir Breastfeeding Warnings

There are no data on the excretion of tipranavir into human 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. Wensing AM, Boucher CA, van Kasteren M, van Dijken PJ, Geelen SP, Juttmann JR "Prevention of mother-to-child transmission of multi-drug resistant HIV-1 using maternal therapy with both enfuvirtide and tipranavir." AIDS 20 (2006): 1465-1467
  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]):

References for breastfeeding information

  1. 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]):
  2. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  3. "Product Information. Aptivus (tipranavir)." Boehringer-Ingelheim, Ridgefield, CT.

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