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FDA NOTE TO CORRESPONDENTS

For Immediate Release: Sept. 15, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA issues new dosing guidance for children using Valcyte
Updated drug label will help prevent potential overdose in underweight transplant patients

The 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.

People using the medication should speak with their health care professional if they have questions about their Valcyte dose.

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.

Health care professionals and patients may report serious adverse events (side effects) with Valcyte to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.

•  Online
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 800-FDA-0178
• Phone: 800-332-1088

Valcyte is manufactured by San Francisco-based Genentech, a member of the Roche Group.

For more information:

Valcyte Drug Safety Communication
 

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