FDA Recommends New Pediatric Dosing Guidelines for Valganciclovir

Disclosures

September 15, 2010

September 15, 2010 — The US Food and Drug Administration (FDA) today announced new recommendations for pediatric dosing of valganciclovir (Valcyte; Genentech) tablets and oral solution to avoid overdoses in pediatric transplant patients with low body weight, low body surface area, and below-normal serum creatinine.

Valganciclovir is prescribed to treat cytomegalovirus (CMV) disease in children receiving kidney or heart transplants (as well as for other indications in adults). CMV can cause severe disease such as pneumonia or colitis in patients with weakened immune systems, including organ-transplant patients.

A pediatric dose of valganciclovir is based on a child's body surface area and creatinine clearance, as calculated with a modified version of the Schwartz formula. However, pediatric patients with low body weight, low body surface area, and below-normal serum creatinine can have high creatinine clearance, as also derived from the modified Schwartz formula, translating into doses approaching the adult level of 900 mg. Adverse effects of valganciclovir overdosing include abdominal pain, vomiting, diarrhea, tremor, or seizure.

To avoid these adverse reactions, the FDA is recommending that when clinicians calculate the dose for valganciclovir, the value for creatinine clearance should not exceed 150 mL/min/1.73m2, even if the modified Schwartz formula yields a higher value. The agency also is recommending an upper limit to the pediatric dose itself. If the calculated dose exceeds 900 mg, a child should receive only 900 mg.

More information about today's FDA announcement is available on the agency's Web site.

To report adverse events related to valganciclovir dosing, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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