Population pharmacokinetics and dose optimization of mycophenolic acid in HCT recipients receiving oral mycophenolate mofetil

Journal of Clinical Pharmacology

Volumn 53, Issue 4, 2013, Pages 393-402

  Li, H ^a   Mager, D E ^a   Sandmaier, B M ^b,c   Maloney, D G ^b,c   Bemer, M J ^b   McCune, J S ^b,c  

^a UNIVERSITY AT BUFFALO   (United States)

^b Fred Hutchinson Cancer Research Center   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Dosing simulation; Hematopoietic cell transplantation; Limited sampling schedule; Mycophenolic acid; Population pharmacokinetics

Indexed keywords

ALEMTUZUMAB; BUSULFAN; CALCINEURIN INHIBITOR; CYCLOPHOSPHAMIDE; CYCLOSPORIN; FLUDARABINE; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; SERUM ALBUMIN; TACROLIMUS;

ACCURACY; ADOLESCENT; ADULT; AGED; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; AREA UNDER THE CURVE; ARTICLE; BAYES THEOREM; BLOOD SAMPLING; CHILD; COMPARTMENT MODEL; DISTRIBUTION VOLUME; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE REGIMEN; DRUG ELIMINATION; FEMALE; HUMAN; LIMITED SAMPLING SCHEDULE; MAJOR CLINICAL STUDY; MALE; MYELOABLATIVE CONDITIONING; NONLINEAR SYSTEM; NONMYELOABLATIVE CONDITIONING; PHARMACOKINETICS; PLASMA CONCENTRATION-TIME CURVE; POPULATION PHARMACOKINETICS; SIMULATION; STATISTICAL MODEL;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTIBIOTICS, ANTINEOPLASTIC; CHILD; CHILD, PRESCHOOL; CYCLOSPORINE; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INFANT; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; MYCOPHENOLIC ACID; SERUM ALBUMIN; TRANSPLANTATION, HOMOLOGOUS; YOUNG ADULT;

EID: 84877852117     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.14     Document Type: Article

References (37)

1. Deeg HJ, Maris MB, Scott BL, Warren EH. Optimization of allogeneic transplant conditioning: not the time for dogma. Leukemia. 2006;20(10):1701- 1705.
2. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clin Pharmacokinet. 2007;46(1):13-58.
3. Giaccone L, McCune JS, Maris MB, et al. Pharmacodynamics of mycophenolate mofetil after nonmyeloablative conditioning and unrelated donor hematopoietic cell transplantation. Blood. 2005; 106(13):4381-4388. Epub 2005 Sep 4386.
4. Jacobson P, Rogosheske J, Barker JN, et al. Relationship of mycophenolic acid exposure to clinical outcome after hematopoietic cell transplantation. Clin Pharmacol Ther. 2005;78(5):486-500.
5. Maris MB, Niederwieser D, Sandmaier BM, et al. HLA-matched unrelated donor hematopoietic cell transplantation after nonmyeloablative conditioning for patients with hematologic malignancies. Blood. 2003;102(6):2021-2030.
6. Nash RA, Johnston L, Parker P, et al. A phase I/II study of mycophenolate mofetil in combination with cyclosporine for prophylaxis of acute graft-versus-host disease after myeloablative conditioning and allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2005;11(7):495-505.
7. van Hest RM, Doorduijn JK, de Winter BC, et al. Pharmacokinetics of mycophenolate mofetil in hematopoietic stem cell transplant recipients. Ther Drug Monit. 2007;29(3):353-360.
8. Maris MB, Sandmaier BM, Storer BE, et al. Unrelated donor granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cell transplantation after nonmyeloablative conditioning: the effect of postgrafting mycophenolate mofetil dosing. Biol Blood Marrow Transplant. 2006;12(4):454-465.
9. Baron F, Little MT, Storb R. Kinetics of engraftment following allogeneic hematopoietic cell transplantation with reduced-intensity or nonmyeloablative conditioning. Blood Rev. 2005;19(3):153-164.
10. Baron F, Baker JE, Storb R, et al. Kinetics of engraftment in patients with hematologic malignancies given allogeneic hematopoietic cell transplantation after nonmyeloablative conditioning. Blood. 2004;104(8):2254- 2262.
11. Li H, Mager DE, Bemer MJ, et al. A limited sampling schedule to estimate mycophenolic acid area under the concentration-time curve in hematopoietic cell transplantation recipients. J Clin Pharmacol. 2012;52 (11):1654-1664. DOI: 10.1177/0091270011429567. Epub 2011 Dec 14.
12. Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol. 2008;48:303-332.
13. Salinger DH, Blough DK, Vicini P, et al. A limited sampling schedule to estimate individual pharmacokinetic parameters of fludarabine in hematopoietic cell transplant patients. Clin Cancer Res. 2009;15(16):5280-5287.
14. Wilkins JJ, Savic RM, Karlsson MO, et al. Population pharmacokinetics of rifampin in pulmonary tuberculosis patients, including a semimechanistic model to describe variable absorption. Antimicrob Agents Chemother. 2008;52(6):2138-2148.
15. Ene I. Ette PJW, Pharmacometrics: the science of quantitative pharmacology. in: Olivier Petricoul VC, E Fuseau, Mathilde M, editors. Population models for drug absorption and enterohepatic recycling. Hoboken, New Jersey: John Wiley & Sons, Inc.; 2007.
16. Venkataramanan R, Jain A, Cadoff E, et al. Pharmacokinetics of FK 506: preclinical and clinical studies. Transplant Proc. 1990;22(1): 52-56.
17. Przepiorka D, Nash RA, Wingard JR, et al. Relationship of tacrolimus whole blood levels to efficacy and safety outcomes after unrelated donor marrow transplantation. Biol Blood Marrow Transplant. 1999;5(2):94-97.
18. van Hest RM, Mathot RA, Pescovitz MD, Gordon R, Mamelok RD, van Gelder T. Explaining variability in mycophenolic acid exposure to optimize mycophenolate mofetil dosing: a population pharmacokinetic meta-analysis of mycophenolic acid in renal transplant recipients. J Am Soc Nephrol. 2006;17(3):871-880.
19. Rezvani AR, Storer BE, Storb RF, et al. Decreased serum albumin as a biomarker for severe acute graft-versus-host disease after reduced-intensity allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2011;17(11):1594-1601.
20. Tett SE, Saint-Marcoux F, Staatz CE, et al. Mycophenolate, clinical pharmacokinetics, formulations, and methods for assessing drug exposure. Transplant Rev (Orlando). 2011;25(2):47-57.
21. van Gelder T, Klupp J, Barten MJ, Christians U, Morris RE. Comparison of the effects of tacrolimus and cyclosporine on the pharmacokinetics of mycophenolic acid. Ther Drug Monit. 2001; 23(2):119-128.
22. Meiser BM, Groetzner J, Kaczmarek I, et al. Tacrolimus or cyclosporine: which is the better partner for mycophenolate mofetil in heart transplant recipients? Transplantation. 2004;78(4):591-598.
23. de Winter BC, Mathot RA, Sombogaard F, et al. Differences in clearance of mycophenolic acid among renal transplant recipients, hematopoietic stem cell transplant recipients, and patients with autoimmune disease. Ther Drug Monit. 2010;32(5):606-614.
24. van Hest RM, van Gelder T, Vulto AG, Mathot RA. Population pharmacokinetics of mycophenolic acid in renal transplant recipients. Clin Pharmacokinet. 2005;44(10):1083-1096.
25. Le Guellec C, Bourgoin H, Buchler M, et al. Population pharmacokinetics and Bayesian estimation of mycophenolic acid concentrations in stable renal transplant patients. Clin Pharmacokinet. 2004;43(4):253-266.
26. de Winter BC, van Gelder T, Glander P, et al. Population pharmacokinetics of mycophenolic acid: a comparison between enteric-coated mycophenolate sodium and mycophenolate mofetil in renal transplant recipients. Clin Pharmacokinet. 2008;47(12): 827-838.
27. van Hest RM, van Gelder T, Bouw R, et al. Time-dependent clearance of mycophenolic acid in renal transplant recipients. Br J Clin Pharmacol. 2007;63(6):741-752.
28. Shum B, Duffull SB, Taylor PJ, Tett SE. Population pharmacokinetic analysis of mycophenolic acid in renal transplant recipients following oral administration of mycophenolate mofetil. Br J Clin Pharmacol. 2003;56(2):188-197.
29. Staatz CE, Duffull SB, Kiberd B, Fraser AD, Tett SE. Population pharmacokinetics of mycophenolic acid during the first week after renal transplantation. Eur J Clin Pharmacol. 2005;61(7):507-516.
30. Musuamba FT, Rousseau A, Bosmans JL, et al. Limited sampling models and Bayesian estimation for mycophenolic acid area under the curve prediction in stable renal transplant patients co-medicated with ciclosporin or sirolimus. Clin Pharmacokinet. 2009;48(11): 745-758.
31. Martin PJ, McDonald GB, Sanders JE, et al. Increasingly frequent diagnosis of acute gastrointestinal graft-versus-host disease after allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2004;10(5):320-327.
32. Ratna P, Mathew BS, Annapandian VM, et al. Pharmacokinetic drug interaction of mycophenolate with co-amoxiclav in renal transplant patients. Transplantation. 2011;91(6):e36-e38.
33. Borrows R, Chusney G, LoucaidouM, et al. The magnitude and time course of changes in mycophenolic acid 12-hour predose levels during antibiotic therapy in mycophenolate mofetil-based renal transplantation. Ther Drug Monit. 2007;29(1):122-126.
34. Naderer OJ, Dupuis RE, Heinzen EL, Wiwattanawongsa K, Johnson MW, Smith PC. The influence of norfloxacin and metronidazole on the disposition of mycophenolate mofetil. J Clin Pharmacol. 2005;45(2):219-226.
35. Saint-Marcoux F, Royer B, Debord J, et al. Pharmacokinetic modelling and development of Bayesian estimators for therapeutic drug monitoring of mycophenolate mofetil in reduced-intensity haematopoietic stem cell transplantation. Clin Pharmacokinet. 2009;48(10):667-675.
36. Ram R, Storer B, Mielcarek M, et al. Association between calcineurin inhibitor blood concentrations and outcomes after allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2012;18(3):414-422.
37. Osunkwo I, Bessmertny O, Harrison L, et al. A pilot study of tacrolimus and mycophenolate mofetil graft-versus-host disease prophylaxis in childhood and adolescent allogeneic stem cell transplant recipients. Biol Blood Marrow Transplant. 2004;10(4): 246-258.