FDA Issues Label Change for Valganciclovir Hydrochloride

New pediatric dosing recommendation issued in an effort to prevent overdosing in children
By Beth Gilbert
HealthDay Reporter

THURSDAY, Sept. 16 (HealthDay News) -- The U.S. Food and Drug Administration has alerted health care professionals of new pediatric dosing recommendations for valganciclovir hydrochloride (Valcyte) in an effort to prevent overdosing in children with low body weight, low body surface area, and below normal serum creatinine.

Valganciclovir hydrochloride is an antiviral drug used to prevent cytomegalovirus infection in children aged 4 months to 16 years who have had a kidney or heart transplant. The pediatric dose of valganciclovir hydrochloride is calculated based on body surface area and creatinine clearance derived from a modified Schwartz formula. Under previous recommendations, pediatric patients with low body weight, low body surface area, and below normal serum creatinine could be administered a dose almost as large as an adult dose.

Accordingly, the FDA is informing health care professionals that a maximum value of 150 mL/min/1.73 m² should be added to the creatinine clearance when calculating the pediatric dose of valganciclovir hydrochloride with the modified Schwartz formula. The agency recommends that if the calculated pediatric dose of valganciclovir hydrochloride exceeds 900 mg, a dose of 900 mg should be administered to the child.

According to a safety alert issued by the agency, "the FDA has determined that adding an upper limit of 150 mL/min/1.73 m² to the creatinine clearance calculated using the Schwartz formula for the determination of pediatric doses can help prevent the potential for Valcyte overdosing."

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