September 15, 2010
New pediatric Valcyte dosing recommendationsThe FDA has notified healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride, from Roche) tablets and oral solution. The pediatric dose of Valcyte is based on body surface area (BSA) and creatinine clearance (CrCl) derived from a modified Schwartz formula. Under previous dosing recommendations, pediatric patients with low body weight, low BSA, and below normal serum creatinine could have a high calculated Schwartz CrCl, resulting in a pediatric dose that approached the adult dose of 900mg.
The FDA has determined that adding an upper limit of 150mL/min/1.73m2 to the CrCl calculated using the Schwartz formula for the determination of pediatric doses can help prevent the potential for Valcyte overdosing in children. Additionally, if the calculated Valcyte dose exceeds 900mg, a dose of 900mg should be given to the child.
Valcyte is indicated for the prevention of cytomegalovirus (CMV) disease in children 4 months to 16 years of age who have undergone a kidney or heart transplant.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm225888.htm.