FDA Updates Rilpivirine Labeling
"On August 26, 2015 the Edurant (rilpivirine) product labeling was updated to include the use of rilpivirine in combination with other antiretroviral agents for the treatment of HIV-1 infection to include treatment-naïve pediatric patients from 12 to less than 18 years of age with HIV-1 RNA less than or equal to 100,00 copies/mL. … In addition to the addition of the adolescent data to the label, changes were made the Warnings and Precautions with respect to Depressive Disorders and updates to the adrenal function subsection in section 6 Adverse Reactions."
The updated labeling will be available at the FDA website.
More information is available:
FDA: Press release
AIDSinfo: Patient fact sheet on rilpivirine
Source: AIDSinfo At-a-Glance: Offering Information on HIV/AIDS Treatment, Prevention, and Research, A Service of the U.S. Department of Health and Human Services (DHHS) - Category: Infectious Diseases Source Type: news
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