New algorithm for valganciclovir dosing in pediatric solid organ transplant recipients

Pediatric Transplantation

Volumn 18, Issue 1, 2014, Pages 103-111

  Asberg A ^a   Bjerre, A ^b   Neely, M ^c  

^a UNIVERSITY OF OSLO   (Norway)

^b OSLO UNIVERSITY HOSPITAL   (Norway)

^c UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

Author keywords

cytomegalovirus; pediatric transplantation; population model; solid organ transplantation; therapeutic drug monitoring; valganciclovir

Indexed keywords

VALGANCICLOVIR;

ADOLESCENT; ALGORITHM; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; CHILD; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EXPOSURE; FEMALE; GLOMERULUS FILTRATION RATE; GRAFT RECIPIENT; GROUPS BY AGE; HEART GRAFT; HUMAN; INFANT; KIDNEY GRAFT; LIVER GRAFT; MAJOR CLINICAL STUDY; MALE; MONTE CARLO METHOD; PRESCHOOL CHILD; PROBABILITY; SCHOOL CHILD;

CYTOMEGALOVIRUS; PEDIATRIC TRANSPLANTATION; POPULATION MODEL; SOLID ORGAN TRANSPLANTATION; THERAPEUTIC DRUG MONITORING; VALGANCICLOVIR;

ADOLESCENT; ALGORITHMS; ANTIVIRAL AGENTS; AREA UNDER CURVE; CHILD; CHILD, PRESCHOOL; COMPUTER SIMULATION; CYTOMEGALOVIRUS INFECTIONS; DRUG MONITORING; FEMALE; GANCICLOVIR; GLOMERULAR FILTRATION RATE; HUMANS; INFANT; MALE; MODELS, THEORETICAL; MONTE CARLO METHOD; ORGAN TRANSPLANTATION; PROBABILITY;

EID: 84891836004     PISSN: 13973142     EISSN: 13993046     Source Type: Journal    
DOI: 10.1111/petr.12179     Document Type: Article

References (22)

1. Åsberg A, Rollag H, Hartmann A,. Valganciclovir for the prevention and treatment of CMV in solid organ transplant recipients. Expert Opin Pharmacother 2010: 11: 1159-1166.
2. Beam E, Razonable RR,. Cytomegalovirus in solid organ transplantation: Epidemiology, prevention, and treatment. Curr Infect Dis Rep 2012: 14: 633-641.
3. Kotton CN, Kumar D, Caliendo AM, et al. Updated international consensus guidelines on the management of cytomegalovirus in solid organ transplantation. Transplantation 2013: 96: 333-360.
4. Pescovitz MD, Rabkin J, Merion RM, et al. Valganciclovir results in improved oral absorption of ganciclovir in liver transplant recipients. Antimicrob Agents Chemother 2000: 44: 2811-2815.
5. Åsberg A, Humar A, Rollag H, et al. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant 2007: 7: 2106-2113.
6. Humar A, Lebranchu Y, Vincenti F, et al. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant 2010: 10: 1228-1237.
7. Paya C, Humar A, Dominguez E, et al. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant 2004: 4: 611-620.
8. Wiltshire H, Paya CV, Pescovitz MD, et al. Pharmacodynamics of oral ganciclovir and valganciclovir in solid organ transplant recipients. Transplantation 2005: 79: 1477-1483.
9. Pescovitz MD, Ettenger RB, Strife CF, et al. Pharmacokinetics of oral valganciclovir solution and intravenous ganciclovir in pediatric renal and liver transplant recipients. Transpl Infect Dis 2010: 12: 195-203.
10. Schwartz GJ, Feld LG, Langford DJ,. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatr 1984: 104: 849-854.
11. Villeneuve D, Brothers A, Harvey E, et al. Valganciclovir dosing using area under the curve calculations in pediatric solid organ transplant recipients. Pediatr Transplant 2013: 17: 80-85.
12. Vaudry W, Ettenger R, Jara P, et al. Valganciclovir dosing according to body surface area and renal function in pediatric solid organ transplant recipients. Am J Transplant 2009: 9: 636-643.
13. Åsberg A, Hansen CN, Reubsaet L,. Determination of ganciclovir in different matrices from solid organ transplanted patients treated with a wide range of concomitant drugs. J Pharm Biomed Anal 2007: 43: 1039-1044.
14. Neely MN, van Guilder MG, Yamada WM, Schumitzky A, Jelliffe RW,. Accurate detection of outliers and subpopulations with Pmetrics, a nonparametric and parametric pharmacometric modeling and simulation package for R. Ther Drug Monit 2012: 34: 467-476.
15. FDA. Application number 22-257s000 and 21-304007.
16. Anderson BJ, Holford NH,. Mechanistic basis of using body size and maturation to predict clearance in humans. Drug Metab Pharmacokinet 2009: 24: 25-36.
17. Cockcroft DW, Gault MH,. Prediction of creatinine clearance from serum creatinine. Nephron 1976: 16: 31-41.
18. Gao A, Cachat F, Faouzi M, et al. Comparison of the glomerular filtration rate in children by the new revised Schwartz formula and a new generalized formula. Kidney Int 2013: 83: 524-530.
19. World Health Organization. The WHO Child Growth Standards. Available at: http://www.who.int/childgrowth/en/.
20. Charhon N, Neely MN, Bourguignon L, Maire P, Jelliffe RW, Goutelle S,. Comparison of four renal function estimation equations for pharmacokinetic modeling of gentamicin in geriatric patients. Antimicrob Agents Chemother 2012: 56: 1862-1869.
21. Duffull S, Waterhouse T, Eccleston J,. Some considerations on the design of population pharmacokinetic studies. J Pharmacokinet Pharmacodyn 2005: 32: 441-457.
22. Pescovitz MD, Ettenger RB, Strife CF, et al. Pharmacokinetics of oral valganciclovir solution and intravenous ganciclovir in pediatric renal and liver transplant recipients. Transpl Infect Dis 2010: 12: 195-203.