FDA Drug Safety Communication

FDA is notifying healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride) oral tablets and oral solution. This change is being made to prevent potential valganciclovir overdosing in children with low body weight, low body surface area, and below normal serum creatinine. Valganciclovir is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children 4 months to 16 years of age who have undergone a kidney or heart transplant.

The revised dosing recommendations are being updated to include an upper limit on the calculated creatinine clearance using the modified Schwartz formula, which is used to calculate the pediatric dose of Valcyte.

Healthcare professionals should:

- Be aware of possible valganciclovir overdose in pediatric patients with low body weight, low body surface area, or below normal serum creatinine.

- When calculating the pediatric dose of Valcyte with the modified Schwartz formula, a maximum value of 150 mL/min/1.73 m2 should be used in the formula.

- When the calculated pediatric dose of Valcyte exceeds 900 mg, a dose of 900 mg should be administered to the child.

View the full FDA Drug Safety Communication on FDA.gov