Mycophenolic acid therapeutic drug monitoring using area under the curve in pediatric heart transplant recipients.
area under the curve
limited sampling strategy
mycophenolic acid
pediatric heart transplant
therapeutic drug monitoring
Journal
Clinical transplantation
ISSN: 1399-0012
Titre abrégé: Clin Transplant
Pays: Denmark
ID NLM: 8710240
Informations de publication
Date de publication:
11 2023
11 2023
Historique:
revised:
10
06
2023
received:
12
03
2023
accepted:
24
07
2023
medline:
13
11
2023
pubmed:
1
8
2023
entrez:
1
8
2023
Statut:
ppublish
Résumé
Pharmacokinetics of mycophenolic acid (MPA) display substantial interpatient variability, with up to 10-fold difference of exposure in individual patients under a fixed-dose regimen. MPA trough level (C0) monitoring is common in clinical practice but has not proven sufficiently informative in predicting MPA exposure or patient outcomes, especially in children. No limited sampling strategies (LSSs) have been generated from pediatric heart transplant (HTx) recipients to estimate MPA AUC. Single-center, observational analysis of 135 de novo pediatric HTx recipients ≤21 years old who underwent MPA AUC between 2011 and 2021. Median age was 4 years (IQR .6-12.1). Median time from transplant to MPA AUC sampling was 15 days (IQR 11-19). MMF doses (mg or mg/day) had low, negative Pearson correlation coefficients (r) while doses adjusted for weight or body surface area had low correlation with Trapezoidal MPA AUC MMF at fixed or weight-adjusted doses, as well as MPA trough levels, correlate poorly with MPA AUC
Substances chimiques
Mycophenolic Acid
HU9DX48N0T
Immunosuppressive Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e15087Informations de copyright
© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Références
Colvin M, Smith JM, Ahn Y, et al. OPTN/SRTR 2020 Annual Data Report: heart. Am J Transplant. 2022;22(Suppl 2):350-437. doi:10.1111/ajt.16977
CELLCEPT. Package insert. Genentech USA, Inc; 2022.
Ehren R, Schijvens AM, Hackl A, Schreuder MF, Weber LT. Therapeutic drug monitoring of mycophenolate mofetil in pediatric patients: novel techniques and current opinion. Expert Opin Drug Metab Toxicol. 2021;17(2):201-213. doi:10.1080/17425255.2021.1843633
Sage DP, Kulczar C, Roth W, Liu W, Knipp GT. Persistent pharmacokinetic challenges to pediatric drug development. Front Genet. 2014;5:281. doi:10.3389/fgene.2014.00281
Bergan S, Brunet M, Hesselink DA, et al. personalized therapy for mycophenolate: consensus report by the international association of therapeutic drug monitoring and clinical toxicology. Ther Drug Monit. 2021;43(2):150-200. doi:10.1097/FTD.0000000000000871
Zuk DM, Pearson GJ. Monitoring of mycophenolate mofetil in orthotopic heart transplant recipients-a systematic review. Transplant Rev (Orlando). 2009;23(3):171-177. doi:10.1016/j.trre.2009.02.002. Epub 2009 Apr 2.
Filler G. Value of therapeutic drug monitoring of MMF therapy in pediatric transplantation. Pediatr Transplant. 2006;10(6):707-711. doi:10.1111/j.1399-3046.2006.00553.x
Filler G, Foster J, Berard R, Mai I, Lepage N. Age-dependency of mycophenolate mofetil dosing in combination with tacrolimus after pediatric renal transplantation. Transplant Proc. 2004;36(5):1327-1331. doi:10.1016/j.transproceed.2004.05.043
Dipchand AI, Pietra B, McCrindle BW, Rosebrook-Bicknell HL, Boucek MM. Mycophenolic acid levels in pediatric heart transplant recipients receiving mycophenolate mofetil. J Heart Lung Transplant. 2001;20(10):1035-1043. doi:10.1016/s1053-2498(01)00305-9
Siddiqi N, Lamour JM, Hsu DT. The effect of MMF dose and trough levels on adverse effects in pediatric heart transplant recipients. Pediatr Transplant. 2015;19(6):618-622. doi:10.1111/petr.12542. Epub 2015 Jun 17. PMID: 26082342.
Gajarski RJ, Crowley DC, Zamberlan MC, Lake KD. Lack of correlation between MMF dose and MPA level in pediatric and young adult cardiac transplant patients: does the MPA level matter? Am J Transplant. 2004;4(9):1495-1500. doi:10.1111/j.1600-6143.2004.00534.x
Zakliczyński M, Szewczyk M, Zakliczyńska H, Zembala M. Clinical application of monitoring mycophenolic acid trough concentration in heart transplant recipients-single center's experience. Ann Transplant. 2005;10(2):38-45.
ISBA Website https://pharmaco.chu-limoges.fr
Woillard JB, Saint-Marcoux F, Monchaud C, Youdarène R, Pouche L, Marquet P. Mycophenolic mofetil optimized pharmacokinetic modelling, and exposure-effect associations in adult heart transplant recipients. Pharmacol Res. 2015;99:308-315. doi:10.1016/j.phrs.2015.07.012
Westley IS, Ray JE, Morris RG. CEDIA mycophenolic acid assay compared with HPLC-UV in specimens from transplant recipients. Ther Drug Monit. 2006;28(5):632-636. doi:10.1097/01.ftd.0000243963.53322.8d
Evers PD, Jorgensen N, Hong B, et al. Outcomes of low-intensity biopsy surveillance for rejection in paediatric cardiac transplantation. Cardiol Young. 2019;29(7):910-916.
Rossano JW, Dipchand AI, Edwards LB, et al. International society for heart and lung transplantation. The registry of the international society for heart and lung transplantation: nineteenth pediatric heart transplantation report-2016; focus theme: primary diagnostic indications for transplant. J Heart Lung Transplant. 2016;35(10):1185-1195.
Chaabane A, Aouam K, Ben Fredj N, et al. Limited sampling strategy of mycophenolic acid in adult kidney transplant recipients: influence of the post-transplant period and the pharmacokinetic profile. J Clin Pharmacol. 2013;53(9):925-933.
Kaczmarek I, Bigdeli AK, Vogeser M, et al. Defining algorithms for efficient therapeutic drug monitoring of mycophenolate mofetil in heart transplant recipients. Ther Drug Monit. 2008;30(4):419-427.
Metz DK, Holford N, Kausman JY, et al. Optimizing mycophenolic acid exposure in kidney transplant recipients: time for target concentration intervention. Transplantation. 2019;103(10):2012-2030.
van Gelder T, Hilbrands LB, Vanrenterghem Y, et al. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation. 1999;68(2):261-266.
Le Meur Y, Büchler M, Thierry A, et al. Individualized mycophenolate mofetil dosing based on drug exposure significantly improves patient outcomes after renal transplantation. Am J Transplant. 2007;7(11):2496-2503.