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. 2024;16(3):403-411.
doi: 10.2174/0125899775266172231004074317.

Suspicious of Acute Kidney Graft Rejection: Tacrolimus Pharmacokinetics Under Methylprednisolone Therapy

Nadielle Silva Bidu  1   2 , Ricardo José Costa Mattoso  3 , Otávio Augusto Carvalho de Oliveira Santos  4   5 , Izabel Almeida Alves  6   7 , Bruno José Dumêt Fernandes  2 , Ricardo David Couto  1   2   4
Affiliations

Suspicious of Acute Kidney Graft Rejection: Tacrolimus Pharmacokinetics Under Methylprednisolone Therapy

Nadielle Silva Bidu et al. Curr Drug Res Rev. 2024.

Abstract

Background: Acute rejection remains one of the main complications in the first months after transplantation and may influence long-term outcomes. Tacrolimus has proven its usefulness in solid organ transplants and its monitoring through the application of pharmacokinetic concepts to optimize individual drug therapy.

Objective: This research proposes to evaluate the tacrolimus pharmacokinetic parameters in patients suspected of acute kidney graft rejection under methylprednisolone pulse therapy.

Methods: Eleven adult tacrolimus-treated renal recipients were selected from a prospective, single-arm, single-center cohort study, with suspicion of acute rejection although in use of methylprednisolone pulses therapy. They were followed up for three months posttransplantation, being tacrolimus trough serum concentrations determined using a chemiluminescent magnetic immunoassay, and pharmacokinetic parameters were estimated by using a nonlinear mixed-effects model implemented by Monolix 2020R1. A tacrolimus trough serum concentration range of 8 to 12 ng.mL-1 was considered therapeutic.

Results: Six patients showed acute cellular rejection, and two of them in addition had an antibody- mediated rejection. Tacrolimus trough serum concentration was below the reference range in eight patients. Most patients showed a high tacrolimus concentration intrapatient and pharmacokinetic parameters variability.

Conclusion: The obtained pharmacokinetics parameters helped in understanding the kidney recipient patients' tacrolimus behavior, assisting in the improvement of individual drug therapy and reducing the risk of acute rejection episodes.

Keywords: Tacrolimus; acute rejection; immunosuppression therapy.; kidney transplantation; pharmacokinetics parameters; therapeutic drug monitoring.

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