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Tipranavir Pregnancy and Breastfeeding Warnings

Tipranavir is also known as: Aptivus

Medically reviewed on June 29, 2018

Tipranavir Pregnancy Warnings

Animal studies have revealed evidence of fetotoxicity (reduced sternebrae ossification and body weights), growth inhibition in pups, and maternal toxicity in rats at exposure levels about 0.8-fold human exposure (at recommended dose). There are no controlled data in human pregnancy.

To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com

No conclusions regarding birth defect risk available; insufficient first-trimester exposures to this drug have been monitored in the APR.

This drug adversely interacts with oral contraceptives; an alternative method of contraception is recommended during therapy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments:
-A pregnancy exposure registry is available.

See references

Tipranavir Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, a different drug may be preferred.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.
-Local guidelines should be consulted if replacement feeding is not an option.

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. "Australian Product Information." O 0
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. 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]):
  6. "Product Information. Aptivus (tipranavir)." Boehringer-Ingelheim, Ridgefield, CT.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." 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. "Product Information. Aptivus (tipranavir)." Boehringer-Ingelheim, Ridgefield, CT.
  5. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  6. 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]):

Further information

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

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