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U.S. Department of Health and Human Services

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Changes to the Edurant (rilpivirine) label: drug-drug interaction with rilpivirine and metformin and rilpivirine and rifabutin

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 complete revised label is available at Drugs@FDA.
 
Edurant is a member of the Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI) class of antiretroviral drugs, marketed by Tibotec Therapeutics.

 

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration