WARNING: HEMATOLOGIC TOXICITY, CARCINOGENICITY, TERATOGENICITY, AND IMPAIRMENT OF FERTILITY
- Clinical toxicity of Valcyte, which is metabolized to ganciclovir, includes granulocytopenia, anemia, and thrombocytopenia [see Warnings and Precautions].
- In animal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis [see Warnings and Precautions
(5.2, 5.3, 5.4) ].
Valcyte (valganciclovir HCl tablets) contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).
Valcyte tablets are indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (see CLINICAL TRIALS).
Valcyte is indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [(D+/R-)]).
Valcyte is not indicated for use in liver transplant patients (see CLINICAL TRIALS and WARNINGS).
The safety and efficacy of Valcyte for the prevention of CMV disease in other solid organ transplant patients such as lung transplant patients have not been established.
Published Studies Related to Valcyte (Valganciclovir)
Long-term efficacy and safety of 12 months of valganciclovir prophylaxis compared with 3 months after lung transplantation: a single-center, long-term follow-up analysis from a randomized, controlled cytomegalovirus prevention trial. [2011.09]
BACKGROUND: The optimal approach to cytomegalovirus (CMV) prevention after lung transplantation is controversial. We recently completed a prospective, randomized, placebo-controlled study of CMV prevention in lung transplantation that demonstrated the short-term efficacy and safety of extending valganciclovir prophylaxis to 12 months vs 3 months of therapy. In the current analysis, we monitored a single-center subset of patients enrolled in the CMV prevention trial to determine if extended prophylaxis conferred a sustained long-term benefit and to assess its hematologic safety... CONCLUSION: Extending valganciclovir prophylaxis to 12 months provides a durable long-term CMV protective benefit compared with short-course therapy, without increasing adverse hematologic effects. Copyright (c) 2011 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.
Valganciclovir reduces T cell activation in HIV-infected individuals with incomplete CD4+ T cell recovery on antiretroviral therapy. [2011.05.15]
BACKGROUND: Elevated immune activation persists during treated human immunodeficiency virus (HIV) infection and is associated with blunted CD4 recovery and premature mortality, but its causes remain incompletely characterized. We hypothesized that asymptomatic cytomegalovirus (CMV) replication might contribute to immune activation in this setting... CONCLUSIONS: CMV (and/or other herpesvirus) replication is a significant cause of immune activation in HIV-infected individuals with incomplete antiretroviral therapy-mediated CD4(+) T cell recovery. CLINICAL TRIALS REGISTRATION: NCT00264290.
Extended valganciclovir prophylaxis in D+/R- kidney transplant recipients is associated with long-term reduction in cytomegalovirus disease: two-year results of the IMPACT study. [2010.12.27]
BACKGROUND: Whether the early reduction in cytomegalovirus (CMV) disease seen at 1 year with prolongation of antiviral prophylaxis (up to 200 days) persists in the long term is unknown... CONCLUSION: Extending valganciclovir prophylaxis from 100 to 200 days is associated with a sustained reduction in CMV disease up to 2 years posttransplant.
Ganciclovir pharmacokinetic parameters do not change when extending valganciclovir cytomegalovirus prophylaxis from 100 to 200 days. [2010.12.27]
BACKGROUND: A 3-month course of prophylaxis is usually recommended for cytomegalovirus (CMV) D+/R- renal transplant recipients. Based on recent data, up to 6 months of prophylaxis may be used. A subanalysis was performed to evaluate the pharmacokinetics of ganciclovir after valganciclovir administration and to perform an exploratory pharmacokinetic/pharmacodynamic analysis... CONCLUSION: The pharmacokinetics of ganciclovir were similar between the two dosing groups (100 vs. 200 days), with the majority of patients achieving an area under the concentration time curve in the target therapeutic range (40-60 mug hr/mL). The fact that the majority of patients were within the target therapeutic range and the absence of a control arm (no treatment) precluded any attempt to validate a correlation with clinical parameters (i.e., CMV disease).
Impact of prophylactic versus preemptive valganciclovir on long-term renal allograft outcomes. [2010.08.27]
BACKGROUND: Both prophylactic and preemptive oral valganciclovir therapy are effective for the management of cytomegalovirus (CMV) postrenal transplantation in the short term. The long-term effect of either strategy is less well defined... CONCLUSIONS: Within the limitations of sample size, our data suggest that either strategy for the management of CMV immediately after transplantation seems effective for patient and graft survival in the long term. CMV management is one of the many therapeutic strategies incorporated into a renal transplantation protocol, which often differs among institutions, and the decision as to which approach to use remains center- and resource-specific. The increased incidence of death in the prophylactic group requires further investigation.
Clinical Trials Related to Valcyte (Valganciclovir)
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients [Completed]
This study will determine the relative efficacy and safety of up to 100 days Valcyte
prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of
CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study
treatment is 3-12 months and the target sample size is 100-500 individuals.
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition [Completed]
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition [Completed]
Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation [Terminated]
The objective of this study is to assess the efficacy and safety of oral valganciclovir
versus intravenous ganciclovir in patients following allogenic stem cell transplantation.
Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients [Completed]
The objectives of this study were:
1. To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV
infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days
2. To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with
respect to ganciclovir given intravenously (i. v.).
3. Evaluate the security of this treatment with valganciclovir.
Reports of Suspected Valcyte (Valganciclovir) Side Effects
Cytomegalovirus Infection (12),
Escherichia Urinary Tract Infection (10),
Gastric Antral Vascular Ectasia (10),
Anaemia Postoperative (10),
Concomitant Disease Progression (10),
Thrombocytopenia (9), more >>
Page last updated: 2011-12-09