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Etravirine Pregnancy and Breastfeeding Warnings

Etravirine is also known as: Intelence

Medically reviewed on April 20, 2017

Etravirine Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.

In a study of 15 pregnant women during the second and third trimesters of pregnancy and postpartum, this drug (200 mg twice a day) was evaluated in combination with other antiretroviral agents. Exposure to total drug was generally higher during pregnancy compared with postpartum; difference was less pronounced for unbound drug exposure.

Placental transfer to the fetus has been reported as variable, usually as moderate to high (cord blood/maternal delivery plasma drug ratio at least 0.3). In 19 mother-infant pairs, the ratio of drug levels in cord blood-to-maternal plasma at delivery ranged from 0.19 to 4.25.

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.

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

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Comments:
-A pregnancy exposure registry is available.

See references

Etravirine 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: 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.

This drug (dose not provided; presumed 200 mg twice a day) was added to the existing antiretroviral regimens of 9 HIV-infected women between days 1 and 14 postpartum. Breast milk and maternal serum samples were collected at 0, 2, 5, 8, and 24 hours after dosing on days 5 and 14 postpartum. Breast milk drug level was 241 mcg/L (range: 161 to 891 mcg/L) on day 5 and 798 mcg/L (range: 161 to 2714 mcg/L) on day 14; milk to plasma ratio was 1.09 and 3.27 on days 5 and 14, respectively.

See references

References for pregnancy information

  1. Johnson LB, Saravolatz LD "Etravirine, a Next-Generation Nonnucleoside Reverse-Transcriptase Inhbitor." Clin Infect Dis (2009):
  2. Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission "Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/perinatalgl.pdf." ([2018, Mar 27]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Intelence (etravirine)." Ortho Biotech Inc, Bridgewater, NJ.
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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. Intelence (etravirine)." Ortho Biotech Inc, Bridgewater, NJ.
  5. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  6. Johnson LB, Saravolatz LD "Etravirine, a Next-Generation Nonnucleoside Reverse-Transcriptase Inhbitor." Clin Infect Dis (2009):
  7. Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission "Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/perinatalgl.pdf." ([2018, Mar 27]):

Further information

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

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