FDA Updates Rilpivirine (Edurant) Labeling
“On May 1, 2014, FDA approved changes to the Edurant (rilpivirine) label to include drug-drug interaction with rilpivirine and metformin and rilpivirine and rifabutin.
“Under section 2 Dosage and Administration:
“Rifabutin Co-administration: For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal. When rifabutin co-administration is stopped, the EDURANT dose should be decreased to 25 mg once daily, taken with a meal.
“Rilpivirine did not have a clinically significant effect on the pharmacokinetics of metformin.”
The revised label is available at the FDA website.
More information is available:
FDA: Press release
AIDSinfo: Rilpivirine (Edurant) patient fact sheet
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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