The Food and Drug Administration (FDA) has approved labeling updates for Valcyte (valganciclovir; Roche) tablets and oral solution to include expanded pediatric indication and dosage sections.
The updated label shows that Valcyte is approved for the prevention of cytomegalovirus (CMV) disease in kidney transplant patients (4 months to 16 years old) and heart transplant patients (1 month to 16 years old) at high risk. In pediatric kidney transplant recipients, the recommended daily dose should start within 10 days of post-transplantation until 200 days post-transplantation. In pediatric heart transplant recipients, the recommended daily dose should start within 10 days of transplantation until 100 days post-transplantation.
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Valcyte is a nucleoside analogue that is also approved for the treatment of AIDS-related CMV retinitis, and for the prevention of CMV disease in adult patients with kidney, heart, and kidney-pancreas transplantation.
The FDA also acknowledged the fulfillment of PREA post-marketing requirements through the Company’s submission of Prior Approval Supplements regarding a tolerability study of valganciclovir for oral solution or tablets in pediatric kidney transplant recipients, as well as a pharmacokinetic and safety study in pediatric heart transplant recipients <4 months old to determine appropriate dosing in this age group.
For more information call (888) 835-2555 or visit Valcyte.com.