USFDA Alerts: Changes to the Edurant (rilpivirine) label

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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.
Source: USFDA
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