Systemic Ganciclovir Exposure
- Valcyte 900 mg QD delivers mean ganciclovir exposure (based on AUC) 1.7 times that of oral ganciclovir 1000 mg TID
Note: Due to its significantly higher bioavailability, Valcyte tablets cannot be substituted for ganciclovir capsules on a one-to-one basis.4
Note: The clinical significance of the differences in ganciclovir pharmacokinetics for these ganciclovir delivery systems is unknown.
In the Phase 3 pivotal trial, the proportion of patients who developed CMV disease, including CMV syndrome and/or tissue-invasive disease during the first 6 months posttransplant was similar between the Valcyte arm (12.1%), N=239) and the oral gancyclovir arm (15.2%), N=125). Mortality at 6 months was 3.7% (9/244) in the Valcyte group and 1.6% (2/126) in the oral ganciclovir group.
Safety
Information
Reference:
4Valcyte® [product information]. Nutley, NJ: Roche Laboratories Inc.; January 2006.