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Rilpivirine Pregnancy and Breastfeeding Warnings

Rilpivirine is also known as: Edurant

Rilpivirine Pregnancy Warnings

Animal studies have failed to reveal evidence of embryofetotoxicity, an effect on reproductive function, or clinically significant teratogenicity; placental transfer was observed. There are no controlled data in human pregnancy. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B1 US FDA pregnancy category: B

See references

Rilpivirine 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. "Product Information. Edurant (rilpivirine)." Tibotec Pharmaceuticals, Titusville, NJ.
  2. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. National Institutes 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/lvguidelines/perina" ([2014 Mar 28 ]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Edurant (rilpivirine)." Tibotec Pharmaceuticals, Titusville, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. National Institutes 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/lvguidelines/perina" ([2014 Mar 28 ]):
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. 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 -]):
  6. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6

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