Jane S. Ricciuti, RPh, MS

Disclosures

October 21, 2003

In This Article

Antiviral Agents

Valcyte
(valganciclovir HCI) Tablets

Manufacturer: Hoffman-La Roche Inc.

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 9/12/03)

New Indication: This supplemental application provides for the use of Valcyte (valganciclovir HCI), 450-mg tablets, for the prevention of cytomegalovirus (CMV) disease in kidney, heart, and kidney-pancreas transplant patients at high risk (donor CMV seropositive/recipient CMV seronegative).

Dosing: For patients who have received a kidney, heart, or kidney-pancreas transplant, the recommended dose is 900 mg (two 450-mg tablets) once daily with food starting within 10 days of transplantation until 100 days after transplantation.

Clinical Summary: Valganciclovir was studied in a double-blind, double-dummy active comparator study that included 372 heart, liver, kidney, and kidney-pancreas transplant patients at high risk for CMV disease (donor seropositive/recipient seronegative). Patients were randomized to receive either valganciclovir (900 mg once daily) or oral ganciclovir (1000 mg 3 times a day) starting within 10 days of transplantation until day 100 after transplantation.

The incidence of CMV disease, including CMV syndrome and/or tissue-invasive disease, during the first 6 months after transplantation was similar between the 2 arms. Patients in the liver transplant group experienced higher incidence of tissue-invasive CMV disease in the valganciclovir group.

Valcyte (valganciclovir HCI) Tablets Labeling

Valcyte (valganciclovir HCI) Tablets

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