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Valganciclovir dosing according to body surface area and renal function in pediatric solid organ transplant

W Vaudry1, R Ettenger, P Jara

  • 1Stollery Children's Hospital, University of Alberta, Edmonton, Canada. wendy.vaudry@capitalhealth.ca

American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons
|March 6, 2009
PubMed

Insights

Oral valganciclovir effectively prevents cytomegalovirus (CMV) disease in pediatric solid organ transplant (SOT) recipients. A weight-based dosing algorithm ensures safe and effective ganciclovir exposure in children, similar to adults.

Area of Science:

  • Pharmacology
  • Transplantation Medicine
  • Pediatric Infectious Diseases

Background:

  • Oral valganciclovir is a standard prophylaxis for cytomegalovirus (CMV) disease in adult solid organ transplant (SOT) recipients.
  • Limited data exist regarding its use and pharmacokinetics in pediatric SOT populations.
  • This study addresses the need for evidence-based pediatric dosing strategies.

Purpose of the Study:

  • To evaluate the pharmacokinetics and safety of oral valganciclovir prophylaxis in pediatric SOT recipients.
  • To assess the adequacy of a specific dosing algorithm (dose = 7 x BSA x CrCLS) in achieving target ganciclovir exposures.
  • To compare the safety profile in children with established adult data.

Main Methods:

  • A prospective study involving 63 pediatric SOT recipients at risk for CMV disease.
  • Valganciclovir prophylaxis administered for up to 100 days.
  • Dosage calculated using the formula: dose (mg) = 7 x body surface area x creatinine clearance (Schwartz method).
  • Population pharmacokinetic analysis to describe ganciclovir exposure; safety endpoints monitored up to 26 weeks.

Main Results:

  • The dosing algorithm effectively normalized ganciclovir exposures across different body sizes and renal functions.
  • Mean ganciclovir exposures were comparable to those considered safe and effective in adults.
  • The treatment exhibited a well-tolerated safety profile, similar to adults, with manageable adverse events.

Conclusions:

  • The proposed valganciclovir dosing algorithm provides consistent and appropriate ganciclovir exposures in pediatric SOT recipients.
  • This strategy supports the safe and effective use of valganciclovir for CMV prophylaxis in children.
  • Further research can build upon these findings to optimize pediatric transplantation protocols.

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