Issue: November 2010
November 01, 2010
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FDA issues creatinine clearance limit for Valcyte

Issue: November 2010
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The FDA has determined that an upper limit of 150 mL/min/1.73 m2 in creatinine clearance can prevent overdosing in certain children taking valganciclovir hydrochloride oral tablets and oral solution. The update has been added to the product’s label, according to an FDA press release.

Valganciclovir hydrochloride overdose has been known to occur in children with low body weight, low body surface area and less than normal serum creatinine. The FDA now recommends that a maximum of 900 mg be administered to pediatric patients, even if the calculated dose exceeds 900 mg, and has added this recommendation to the product’s label.

Valganciclovir hydrochloride (Valcyte, Genentech) is indicated to prevent cytomegalovirus (CMV) in children ages 4 to 16 who have had a heart or kidney transplant. The antiviral medication is also used to treat CMV retinitis in adults with AIDS and prevent CMV in patients at high risk for the disease after heart, kidney or kidney-pancreas transplantation.

The FDA asked that all physicians report adverse events involving valganciclovir hydrochloride through the MedWatch Adverse Events Reporting program. In addition, people using the medication who have questions about their dose should speak with their health care professional.

PERSPECTIVE

David W. Kimberlin, MD
David W. Kimberlin

The FDA’s recent reexamination of valganciclovir dosing which led to this modification demonstrates the need for and the power of the MedWatch Adverse Event Reporting program. While valganciclovir is not a terribly commonly prescribed drug, knowledge of how to most safely administer it is critical for those at-risk pediatric patients. As such, dissemination of information such as this is very important.

– David W. Kimberlin, MD

Infectious Diseases in Children Editorial Board