Antiviral Agents
Valcyte (valganciclovir HCI) TabletsManufacturer: 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.
Medscape Pharmacists. 2003;4(2) © 2003 Medscape
Cite this: October 2003 - Medscape - Oct 22, 2003.
