PMID- 19260840
OWN - NLM
STAT- MEDLINE
DCOM- 20090508
LR  - 20230124
IS  - 1600-6143 (Electronic)
IS  - 1600-6135 (Linking)
VI  - 9
IP  - 3
DP  - 2009 Mar
TI  - Valganciclovir dosing according to body surface area and renal function in 
      pediatric solid organ transplant recipients.
PG  - 636-43
LID - 10.1111/j.1600-6143.2008.02528.x [doi]
AB  - Oral valganciclovir is effective prophylaxis for cytomegalovirus (CMV) disease in 
      adults receiving solid organ transplantation (SOT). However, data in pediatrics 
      are limited. This study evaluated the pharmacokinetics and safety of 
      valganciclovir oral solution or tablets in 63 pediatric SOT recipients at risk of 
      CMV disease, including 17 recipients < or =2 years old. Patients received up to 
      100 days' valganciclovir prophylaxis; dosage was calculated using the algorithm: 
      dose (mg) = 7 x body surface area x creatinine clearance (Schwartz method; 
      CrCLS). Ganciclovir pharmacokinetics were described using a population 
      pharmacokinetic approach. Safety endpoints were measured up to week 26. Mean 
      estimated ganciclovir exposures showed no clear relationship to either body size 
      or renal function, indicating that the dosing algorithm adequately accounted for 
      both these variables. Mean ganciclovir exposures, across age groups and organ 
      recipient groups were: kidney 51.8 +/- 11.9 microg * h/mL; liver 61.7 +/- 29.5 
      microg * h/mL; heart 58.0 +/- 21.8 microg * h/mL. Treatment was well tolerated, 
      with a safety profile similar to that in adults. Seven serious treatment-related 
      adverse events (AEs) occurred in five patients. Two patients had CMV viremia 
      during treatment but none experienced CMV disease. In conclusion, a 
      valganciclovir-dosing algorithm that adjusted for body surface area and renal 
      function provides ganciclovir exposures similar to those established as safe and 
      effective in adults.
FAU - Vaudry, W
AU  - Vaudry W
AD  - Stollery Children's Hospital, University of Alberta, Edmonton, Canada. 
      wendy.vaudry@capitalhealth.ca
FAU - Ettenger, R
AU  - Ettenger R
FAU - Jara, P
AU  - Jara P
FAU - Varela-Fascinetto, G
AU  - Varela-Fascinetto G
FAU - Bouw, M R
AU  - Bouw MR
FAU - Ives, J
AU  - Ives J
FAU - Walker, R
AU  - Walker R
CN  - Valcyte WV16726 Study Group
LA  - eng
GR  - M01-RR0865/RR/NCRR NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Transplant
JT  - American journal of transplantation : official journal of the American Society of 
      Transplantation and the American Society of Transplant Surgeons
JID - 100968638
RN  - GCU97FKN3R (Valganciclovir)
RN  - P9G3CKZ4P5 (Ganciclovir)
SB  - IM
MH  - Adolescent
MH  - Algorithms
MH  - *Body Surface Area
MH  - Child
MH  - Child, Preschool
MH  - Cytomegalovirus Infections/*prevention & control
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Ganciclovir/administration & dosage/adverse effects/*analogs & 
      derivatives/pharmacokinetics/pharmacology
MH  - *Heart Transplantation
MH  - Humans
MH  - Infant
MH  - Kidney/*physiology
MH  - *Kidney Transplantation
MH  - *Liver Transplantation
MH  - Male
MH  - Valganciclovir
FIR - Walker, Rowan
IR  - Walker R
FIR - Birk, Patricia
IR  - Birk P
FIR - Vaudry, Wendy
IR  - Vaudry W
FIR - Niaudet, Patrick
IR  - Niaudet P
FIR - Hetzer, Robert
IR  - Hetzer R
FIR - Ojeda, Simon
IR  - Ojeda S
FIR - Varela-Fascinetto, Gustavo
IR  - Varela-Fascinetto G
FIR - Jara, Paloma
IR  - Jara P
FIR - Melgosa-Hijosa, Marta
IR  - Melgosa-Hijosa M
FIR - Manzanares, Javier
IR  - Manzanares J
FIR - Simon, Jose
IR  - Simon J
FIR - Emre, Sukru
IR  - Emre S
FIR - Ettenger, Robert
IR  - Ettenger R
FIR - Hmeil, Paul
IR  - Hmeil P
FIR - Pescovitz, Mark
IR  - Pescovitz M
FIR - Sherbotie, Joseph
IR  - Sherbotie J
FIR - Thomas, Susan
IR  - Thomas S
EDAT- 2009/03/06 09:00
MHDA- 2009/05/09 09:00
CRDT- 2009/03/06 09:00
PHST- 2009/03/06 09:00 [entrez]
PHST- 2009/03/06 09:00 [pubmed]
PHST- 2009/05/09 09:00 [medline]
AID - S1600-6135(22)01610-0 [pii]
AID - 10.1111/j.1600-6143.2008.02528.x [doi]
PST - ppublish
SO  - Am J Transplant. 2009 Mar;9(3):636-43. doi: 10.1111/j.1600-6143.2008.02528.x.