FDA Approves Reyataz Labeling Update for Pregnant Women
February 16, 2011
Bristol-Myers Squibb Company announced on February 7 that the U.S. Food and Drug Administration (FDA) has approved an update to the labeling for Reyataz (atazanavir sulfate) to include dose recommendations in HIV-positive pregnant women. In HIV combination therapy, treatment with the recommended adult dose of 300 mg Reyataz, boosted with 100 mg of Norvir (ritonavir), achieved minimum plasma concentrations (24 hours post-dose) during the third trimester of pregnancy comparable to that observed historically in HIV-positive adults. During the postpartum period, Reyataz concentrations may be increased; therefore, while no dose adjustment is necessary, patients should be monitored for adverse events for two months after delivery. Reyataz should be used during pregnancy only if the benefit outweighs the risk and HIV-1 strains are susceptible to Reyataz. It should not be used without Norvir in pregnant or postpartum women. Reyataz does not have an indication for prevention of mother-to-child transmission of HIV-1 infection.
Pregnant women do not require a dose adjustment for Reyataz/ritonavir except in the case of treatment-experienced pregnant women during the second or third trimester when Reyataz is co-administered with either Viread (tenofovir) or an H2-receptor antagonist (H2RA), used to treat acid reflux. In that case, Reyataz 400 mg plus ritonavir 100 mg once daily is recommended.
"This labeling update is important news for both healthcare providers and HIV-positive women of child-bearing age in that it provides guidance for the use of Reyataz, as part of combination therapy, during pregnancy and postpartum," said Dr. Awny Farajallah, MD, FACP, executive director, atazanavir development lead, Bristol-Myers Squibb. "Bristol-Myers Squibb is committed to research that furthers the understanding of how to manage HIV in special populations and to meeting the evolving needs of individuals with this disease."
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