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Delavirdine Pregnancy and Breastfeeding Warnings

Delavirdine is also known as: Rescriptor

Medically reviewed on October 21, 2016.

Delavirdine Pregnancy Warnings

Delavirdine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity in rats at doses producing exposure equal to or less than the anticipated human exposure at the recommended dose. There are no controlled data in human pregnancy. Delavirdine should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Seven unplanned pregnancies were reported during premarketing clinical studies in patients who received delavirdine. Three resulted in ectopic pregnancies, three resulted in healthy live births, and one was born prematurely with a muscular ventricular septal defect. The mother of the latter infant received treatment with delavirdine and zidovudine for approximately 6 weeks early in the course of pregnancy. Descriptions of maternal exposure to delavirdine in the other cases were not reported.

An Antiretroviral Pregnancy Registry has been established to monitor maternal:fetal outcome of delavirdine exposures during pregnancy. To register patients, physicians should call 1-800-258-4263.

See references

Delavirdine Breastfeeding Warnings

There are no data on the excretion of delavirdine 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. 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. "Product Information. Rescriptor (delavirdine)." Pharmacia and Upjohn, Kalamazoo, MI.

References for breastfeeding information

  1. "Product Information. Rescriptor (delavirdine)." Pharmacia and Upjohn, Kalamazoo, MI.
  2. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  3. 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]):

Further information

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

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