From the Guidelines
The recommended dose of valganciclovir for pediatric patients after renal transplantation is 7 × BSA × CrCl (calculated using the modified Schwartz formula) once daily, with a maximum dose of 900 mg once daily, as this dosing regimen ensures adequate drug exposure while accounting for differences in metabolism and renal function in children compared to adults 1.
Key Considerations
- The dose of valganciclovir should be adjusted based on creatinine clearance, with specific dose recommendations for patients with renal impairment, including a dose of 450 mg daily for patients with a creatinine clearance of 40-59 mL/min, and 450 mg twice weekly for patients with a creatinine clearance of 10-24 mL/min 1.
- Valganciclovir is effective in preventing cytomegalovirus (CMV) infection in pediatric patients after renal transplantation, and is converted to ganciclovir in the body, which inhibits viral DNA polymerase and prevents CMV replication.
- Regular monitoring of complete blood counts and renal function is essential during treatment with valganciclovir, as common side effects include neutropenia, anemia, and gastrointestinal disturbances.
Dosing Adjustments
- For patients with a creatinine clearance of 40-59 mL/min, the recommended dose of valganciclovir is 450 mg daily 1.
- For patients with a creatinine clearance of 25-39 mL/min, the recommended dose of valganciclovir is 450 mg daily 1.
- For patients with a creatinine clearance of 10-24 mL/min, the recommended dose of valganciclovir is 450 mg twice weekly 1.
- For patients with a creatinine clearance of less than 10 mL/min, valganciclovir is not recommended 1.
From the FDA Drug Label
The daily doses of valganciclovir tablets were calculated at each study visit based on body surface area and a modified creatinine clearance [see Dosage and Administration ( 2. 3)].
The dose for valganciclovir in pediatric post renal transplant patients is calculated based on body surface area and modified creatinine clearance.
- The exact dose is not specified in the label, but it is determined by the patient's individual characteristics.
- The label refers to Dosage and Administration (2.3) for more information on dose calculation, but this section is not provided. 2
From the Research
Valganciclovir Dosing in Pediatric Post-Renal Transplant Patients
- The dose for valganciclovir in pediatric post-renal transplant patients can be calculated using the algorithm: dose (mg) = 7 x body surface area x creatinine clearance (Schwartz method; CrCLS) 3
- This dosing algorithm provides ganciclovir exposures similar to those established as safe and effective in adults 3
- The use of valganciclovir in pediatric patients is effective prophylaxis for cytomegalovirus (CMV) disease in solid organ transplant recipients, including kidney transplant patients 3
- Mean ganciclovir exposures in kidney transplant patients were 51.8 +/- 11.9 microg * h/mL 3
- Accurate estimation of renal function is crucial for ganciclovir/valganciclovir dose optimization, and the Chronic Kidney Disease EPIdemiology Collaboration (CKD-EPI) formula was identified as the best predictor of between-patient variability in GCV clearance 4
Considerations for Dosing
- Pediatric patients with renal impairment require special consideration for dosing, as alterations in renal clearance and metabolism of drugs can lead to drug toxicity 5
- Clinical evidence for pediatric renal dosing recommendations is limited, and adult renal dosing recommendations are often used as a primary source of information 5
- Therapeutic drug monitoring (TDM) can help optimize ganciclovir dosing in transplant recipients, including pediatric patients 6
- Significant intra- and inter-patient variability in ganciclovir concentrations can occur, highlighting the need for individualized dosing 6