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Valcyte
CLINICAL PHARMACOLOGY
Valcyte
Pharmacokinetics
BECAUSE THE MAJOR ELIMINATION PATHWAY FOR GANCICLOVIR IS RENAL, DOSAGE REDUCTIONS ACCORDING TO CREATININE CLEARANCE ARE REQUIRED FOR VALCYTE TABLETS. FOR DOSING INSTRUCTIONS IN PATIENTS WITH RENAL IMPAIRMENT, REFER TO DOSAGE AND ADMINISTRATION.
The pharmacokinetic properties of valganciclovir have been evaluated in HIV- and CMV-seropositive patients, patients with AIDS and CMV retinitis and in solid organ transplant patients.
The ganciclovir pharmacokinetic measures following administration of 900 mg Valcyte and 5 mg/kg intravenous ganciclovir and 1000 mg three times daily oral ganciclovir in HIV-positive/CMV-positive patients are summarized in Table 1 .
| Table 1 Mean Ganciclovir Pharmacokinetic* Measures in Healthy Volunteers and HIV-positive/CMV-positive Adults at Maintenance Dosage | |||
| Formulation | Valcyte Tablets | CytoveneÒ -IV | Ganciclovir Capsules |
| Dosage | 900 mg once daily with food | 5 mg/kg once daily | 1000 mg three times daily with food |
| AUC0-24 hr (mg·h/mL) | 29.1 ± 9.7 (3 studies, n=57) | 26.5 ± 5.9 (4 studies, n=68) | Range of means 12.3 to 19.2(6 studies, n=94) |
| Cmax (mg/mL) | 5.61 ± 1.52 (3 studies, n=58) | 9.46 ± 2.02 (4 studies, n=68) | Range of means 0.955 to 1.40 (6 studies, n=94) |
| Absolute oral bioavailability (%) | 59.4 ± 6.1 (2 studies, n=32) | Not Applicable | Range of means 6.22 ± 1.29 to 8.53 ± 1.53 (2 studies, n=32) |
| Elimination half-life (hr) | 4.08 ± 0.76 (4 studies, n=73) | 3.81 ± 0.71 (4 studies, n=69) | Range of means3.86 to 5.03 (4 studies, n=61) |
| Renal clearance (mL/min/kg) | 3.21 ± 0.75 (1 study, n=20) | 2.99 ± 0.67 (1 study, n=16) | Range of means 2.67 to 3.98 (3 studies, n=30) |
| *Data were obtained from single and multiple dose studies in healthy volunteers, HIV-positive patients, and HIV-positive/CMV-positive patients with and without retinitis. Patients with CMV retinitis tended to have higher ganciclovir plasma concentrations than patients without CMV retinitis. | |||
The area under the plasma concentration-time curve (AUC) for ganciclovir administered as Valcyte tablets is comparable to the ganciclovir AUC for intravenous ganciclovir. Ganciclovir Cmax following Valcyte administration is 40% lower than following intravenous ganciclovir administration. During maintenance dosing, ganciclovir AUC0-24 hr and Cmax following oral ganciclovir administration (1000 mg three times daily) are lower relative to Valcyte and intravenous ganciclovir. The ganciclovir Cmin following intravenous ganciclovir and Valcyte administration are less than the ganciclovir Cmin following oral ganciclovir administration. The clinical significance of the differences in ganciclovir pharmacokinetics for these three ganciclovir delivery systems is unknown.
Figure 1 Ganciclovir Plasma Concentration Time Profiles in HIV-positive/CMV-positive Patients*
*Plasma concentration-time profiles for ganciclovir (GCV) from Valcyte (VGCV) and intravenous ganciclovir were obtained from a multiple dose study (WV15376 n=21 and n=18, respectively) in HIV-positive/CMV-positive patients with CMV retinitis. The plasma concentration-time profile for oral ganciclovir was obtained from a multiple dose study (GAN2230 n=24) in HIV-positive/CMV-positive patients without CMV retinitis.
Generic Name: Valganciclovir Hcl
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