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