Limited sampling strategy for the estimation of mycophenolic acid area under the curve in Tunisian renal transplant patients

Mycophenolate mofetil is a prodrug widely used in renal transplantation to prevent organ rejection. It is hydrolyzed to its active compound mycophenolic acid (MPA). MPA area under the curve (AUC(0-12h)) is considered the best pharmacokinetic parameter for the estimation of MPA exposition and for prediction of rejection. MPA-AUC requires several blood samples, making it impractical for clinical practice. Therefore, development of a limited sampling strategy (LSS) to estimate MPA AUCo-in using three blood samples is very helpful for MPA individual dose adjustment. Results of LSS differ according to the patient background and to the drug formulation. Therefore, the purpose of this study was to develop a LSS for the estimation of MPA AUC(0-12h) in Tunisian renal transplant patients treated with the generic formulation of mycophenolate mofetil (MMF,.MEDIS). The best correlation was achieved by a profile based on three time points Cosh, C-1.5h, and C-4h after drug intake: AUC(0-12h) = 0.414 + 1.210 x C-0.5 + 2.256 x C-1.5 + 4.134 x C-4 (mei = 1.65% and rmse = 5.81%). The correlation between full AUC(0-12h) and abbreviated AUC(0-12h) was 0.917. In conclusion, this model provides a reliable and simple equation to estimate MPA AUC(0-12h) for the generic formulation of mycophenolate mofetil (MMF 6). (C) 2017 Societe francophone de nephrologie, dialyse et transplantation. Published by Elsevier Masson SAS. All rights reserved.