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Label Changes for:

Envarsus XR (tacrolimus extended release)

June 2016

Changes have been made to the PRECAUTIONS sections of the safety label.

p>Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

June 2016

USE IN SPECIFIC POPULATIONS

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  • (Addition of sentence) The pharmacokinetics of ENVARSUS XR were evaluated in a study of 46 stable African-American kidney transplant recipients converted from tacrolimus immediate-release to ENVARSUS XR and indicated that an 80% conversion factor is appropriate for African-American patients.
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