Risk of Overdose Prompts Valcyte Dosing Revisions

Washington, DCThe U.S. Food and Drug Administration is notifying health care professionals of updated dosing recommendations for Valcyte (valganciclovir) oral tablets and solution used by children and adolescents receiving a kidney or heart transplant. The update is intended to prevent drug overdosing of children with low body weight, low body surface area, and very low serum creatinine. The revised dosing instructions now appear in the product's label.

The revised pediatric dosing recommendations now include an upper limit on "calculated creatinine clearance," a measurement of kidney function. Creatinine is a waste product produced by the body during energy production and is eliminated by the kidneys.

Creatinine levels in the blood are used to estimate how well kidneys are functioning. High creatinine levels may signal poor kidney function, while low creatinine levels may be observed in patients who are not muscular.

Valcyte is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children from 4 months to 16 years of age who have undergone a kidney or heart transplant and who are at a higher risk of getting the disease. CMV is a virus that can cause severe disease such as pneumonia or colitis in people with weakened immune systems, including organ transplant patients.

The medication is also approved to treat CMV retinitis (when the virus infects the eyes) in adults who have acquired immunodeficiency syndrome (AIDS) and is used to prevent CMV disease in people who have received a heart, kidney, or kidney-pancreas transplant with a high risk of getting CMV disease.