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

Abstract 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 AUC 0−12h 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 C 0.5h , C 1.5h , and C 4h after drug intake: AUC 0−12h  = 0.414 + 1.210 × C 0.5  + 2.256 × C 1.5  + 4.134 × 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 ® ).