Posted by Michael Wonder on 19 Jul 2016
U.S. FDA approves Prezista (darunavir) for use in pregnant women with HIV
18 July 2016 - Data show Prezista is a safe and effective treatment option in pregnant women, with no reports of mother-to-child HIV transmission among women who continued therapy through delivery.
Janssen Therapeutics today announced that the U.S. FDA has approved an expansion to the Prezista (darunavir ethanolate) U.S. Prescribing Information to include data and results from a study investigating the use of Prezista during pregnancy and the postpartum period. A human immunodeficiency virus (HIV-1) protease inhibitor, Prezista is indicated for the treatment of HIV-1 infection in adult and pediatric patients three years of age and older in combination with ritonavir with other antiretroviral agents.
The recent label update includes dosing recommendations for pregnant women with HIV, and data demonstrates that Prezista taken with ritonavir was found to be well-tolerated during pregnancy and the post-partum period.
