Label Changes for:
Envarsus XR (tacrolimus extended release)
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)
USE IN SPECIFIC POPULATIONS
- (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.