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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. HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission "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: https://aidsinfo.nih.gov/contentfiles/lvguidelines/pe" ([2015 Aug 6]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  5. "Product Information. Aptivus (tipranavir)." Boehringer-Ingelheim, Ridgefield, CT.
  6. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ([1999]):

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission "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: https://aidsinfo.nih.gov/contentfiles/lvguidelines/pe" ([2015 Aug 6]):
  5. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  6. "Product Information. Aptivus (tipranavir)." Boehringer-Ingelheim, Ridgefield, CT.

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