FDA Approves Labeling Update for REYATAZ Capsules to Include Data Supporting the Recommended Adult Dose for HIV-1 Infected Pregnant Women

Bristol-Myers Squibb Company BMY today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the labeling for REYATA to include dose recommendations in HIV-infected pregnant women. In HIV combination therapy, treatment with the recommended adult dose of REYATAZ 300 mg, boosted with 100 mg of ritonavir, achieved minimum plasma concentrations during the third trimester of pregnancy comparable to that observed historically in HIV-infected adults. During the postpartum period, atazanavir concentrations may be increased; therefore, while no dose adjustment is necessary, patients should be monitored for adverse events for two months after delivery. REYATAZ is indicated in combination with other antiretroviral agents for treatment of HIV-1 infection in patients at least six years of age.