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A Critical Analysis of Equations for MPA Exposure in Patients Under EC-MPS and Tacrolimus.

E. David-Neto, A. Triboni, F. Ramos, F. Agena, P. Romano, G. Freitas.

Hospital das Clinicas FMUSP, Sao Paulo, Brazil

Meeting: 2017 American Transplant Congress

Abstract number: D104

Keywords: Pharmacokinetics

Session Information

Session Name: Poster Session D: Kidney Immunosuppression: Novel Regimens and Drug Minimization

Session Type: Poster Session

Date: Tuesday, May 2, 2017

Session Time: 6:00pm-7:00pm

 Presentation Time: 6:00pm-7:00pm

Location: Hall D1

Mycophenolic acid(MPA) PK, from enteric-coated mycophenolate sodium(EC-MPS) has a broad range of Tmax avoiding the use a single concentration to calculate the area-under-the-time-concentration curve(AUC). Either for research or for clinical MPA monitoring, a complete AUC is troublesome for the patients(pts). We have developed abbreviated equations in 59 adult(54±16y) pts (29males,43whites) with 171 complete MPA-AUC0-12h, under TAC/EC-MPS using 59 curves measured at mean of 31±4days after transplant, to develop the equations, and the remaining 112 performed at a mean of 109±59d for validation. We also compared our results with 5 other equations(4 with EMIT) available in the literature, comparing estimated AUC(eAUC) with measured AUC(mAUC), bias and 10%/30% accuracy. MPA was measured by UPLC MS-MS. EMIT data was transformed using Emit=1.012HPLC+0.244. The eAUCs that measure MPA up to 6hours, had an acceptable low bias with more results in the 10-30% range than those up to 4h. A highly adequate eAUC is obtained with 8h of blood collection. This analysis offers blood sampling alternatives depending on the precision needed.

Equations eAUC p Bias 30% 10%
Emit (MPA) mAUC= 56±36 [micro]g*hr/mL
Sanchez Ther Drug Monit, 2012 11.15+0.68xC1+0.45xC1.5+0.57xC2+8.16xC4 57±35 NS +1±19 74 29
Yao Ther Drug Monit, 2015 10.44+0.7xC1+1.22xC2+1.75xC4+4.36xC6 55±29 0.026 -2.5±14 79 40
Sommerer Br J Clin Pharmacol, 2010 11.5+0.99xC0+1.56xC1+0.74xC2+0.87xC3+2.09xC4 49±25 0.000 -7±16 78 29
Huang Int J Clin Pharmacol Ther, 2016 22.13+1.7xC0.5+0.61xC1.5+0.78xC2+1.83xC4 52±21 0.025 -3±19 67 23
(UPLC MS-MS) (MPA) mAUC = 53±34 [micro]g*hr/mL eAUC p Bias 30% 10%
HC –FMUSP8h 0,081+0,661xC0+0,564xC1.5+0,768xC2+1,600xC3+1,560xC4+2,421xC6 +3,590xC8 53±34 NS 0±14 96 56
HC –FMUSP6h 1,044+2,150xC0.33+0,601xC1.5+0,836xC2+1,107xC3+2,337xC4+3,454xC6 55±36 NS +2.2±16 90 44
HC –FMUSP4h -1,844+1,683xC0+1,836xC0,66+0,752xC1.5+0,924xC2+0,380xC3+5,852xC4 60±42 0.002 +6.6±22 73 36
Li Am J Nephrol, 2013 -3.63+8.35xC4+17.04xC7+13.74xC12 121±94 0.000 69±68 11 4

CITATION INFORMATION: David-Neto E, Triboni A, Ramos F, Agena F, Romano P, Freitas G. A Critical Analysis of Equations for MPA Exposure in Patients Under EC-MPS and Tacrolimus. Am J Transplant. 2017;17 (suppl 3).

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To cite this abstract in AMA style:

David-Neto E, Triboni A, Ramos F, Agena F, Romano P, Freitas G. A Critical Analysis of Equations for MPA Exposure in Patients Under EC-MPS and Tacrolimus. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/a-critical-analysis-of-equations-for-mpa-exposure-in-patients-under-ec-mps-and-tacrolimus/. Accessed May 25, 2025.

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