Evidence Evaluation and Rationality Analysis for Off-label Use of Tacrolimus in the Kidney Diseases in Adults

OBJECTIVE  To evaluate the levels of evidence and analyze the rationality for off-label use of tacrolimus in the kidney diseases in adults.

METHODS  By systematically reviewing the drug instructions, clinical guidelines and medical literature of tacrolimus in the kidney diseases in adults, screening the highest level of evidence, and an evaluation table based on evidence-based medical for off-label use of tacrolimus in the kidney diseases in adults was established. Based on the evaluation table, collect adult patients from the Department of Nephrology in Zhongda Hospital Southeast University who had a medication history of off-label use of tacrolimus from January 1, 2021 to December 31, 2022, and evaluated the rationality of application for tacrolimus.

RESULTS  A total of 19 indications for off-label use of tacrolimus in the kidney diseases in adults were listed, and their recommended levels were determined based on evidence. Among them, the recommended levels for common types of kidney diseases were higher. In addition, 194 adult patients with off-label use of tacrolimus were selected from the Department of Nephrology in Zhongda Hospital Southeast University, and their application recommended levels with "strongly recommended""moderately strongly recommended""weakly recommended" and "not recommended", were 67.0%, 12.9%, 15.0% and 5.1%, respectively.

CONCLUSION  Tacrolimus has a wide range of indications for off-label use in the kidney diseases in adults, but the evidence for most common types of kidney diseases are relatively sufficient and their use are reasonable.