Delavirdine Pregnancy and Breastfeeding Warnings
Delavirdine is also known as: Rescriptor
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.
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.
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