(ganciclovir sodium for injection)
FOR INTRAVENOUS INFUSION ONLY
Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). CYTOVENE-IV is the brand name for ganciclovir sodium for injection. CYTOVENE-IV is available as sterile lyophilized powder in strength of 500 mg per vial for intravenous administration only. Each vial of CYTOVENE-IV contains the equivalent of 500 mg ganciclovir as the sodium salt (46 mg sodium). Reconstitution with 10 mL of Sterile Water for Injection, USP, yields a solution with pH 11 and a ganciclovir concentration of approximately 50 mg/mL. Further dilution in an appropriate intravenous solution must be performed before infusion (see DOSAGE AND ADMINISTRATION).
CYTOVENE-IV is indicated for the treatment of CMV retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS). CYTOVENE-IV is also indicated for the prevention of CMV disease in transplant recipients at risk for CMV disease (see CLINICAL TRIALS).
SAFETY AND EFFICACY OF CYTOVENE-IV HAS NOT BEEN ESTABLISHED FOR CONGENITAL OR NEONATAL CMV DISEASE; NOR FOR THE TREATMENT OF ESTABLISHED CMV DISEASE OTHER THAN RETINITIS; NOR FOR USE IN NON-IMMUNOCOMPROMISED INDIVIDUALS.
Published Studies Related to Cytovene-IV (Ganciclovir)
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).
[Clinical efficacy of treating infant cytomegalovirus hepatitis with ganciclovir and impact on cytokines]. [2010.11]
AIM: To observe the clinical efficacy of treating infant cytomegalovirus (CMV) hepatitis with ganciclovir and impact on cytokines... CONCLUSIONS: The induction and maintenance treatment of ganciclovir in treatment of infant CMV hepatitis can make the body to restore balance of specific cellular immunity, and can significantly improve the symptoms of jaundice, liver function and clinical efficay and it is worthy to be popularized.
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 Cytovene-IV (Ganciclovir)
A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy [Completed]
To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a
single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy. To
compare the time to progression of cytomegalovirus (CMV) retinitis between two regimens of
oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy. To
describe the efficacy and safety of double dose versus single dose oral ganciclovir in
patients who have a progression of retinitis while on the originally assigned maintenance
treatment. To describe the safety, tolerance, and time to progression of retinitis during the
52 weeks of oral ganciclovir maintenance therapy in people with AIDS. To describe the safety
and tolerance of oral ganciclovir maintenance therapy when given concurrently with
antiretroviral treatment (e. g., zidovudine, ddI, or ddC). To describe survival of people with
AIDS and CMV retinitis.
A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients [Completed]
To determine the oral bioavailability of three dose levels of oral ganciclovir given with and
without glutamic acid hydrochloride in patients with cytomegalovirus (CMV) GI disease, and to
compare the bioavailability of these regimens to that of standard intravenous (IV)
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis
following induction treatment. Oral ganciclovir is a likely candidate for maintenance because
of its possible therapeutic value and ease of administration, but an optimum dose has not
been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an
acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal
absorption of this drug.
A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis [Completed]
To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV)
disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal
ganciclovir implant. To compare safety and tolerance, time to progression, quality of life,
and survival among patients treated with an intravitreal ganciclovir implant, with and
without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.
A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir [Completed]
To examine the safety and tolerance of the administration of ganciclovir and foscarnet given
together or alternately; to determine the interactive pharmacokinetics (blood level) profile
of long-term combined and alternating therapy with these two drugs. Additional objectives are
to examine the effect of these treatments in controlling time to cytomegalovirus (CMV)
retinitis progression and to examine the antiviral activity of combined and alternating
ganciclovir/foscarnet treatment and development of antiviral resistance. Sight-threatening
CMV retinitis occurs in at least 6 percent of AIDS patients. By 1991 (US), there may be 6000
to 10000 patients with CMV retinitis. Many clinical reports suggest that both ganciclovir
(DHPG) and foscarnet have an antiviral effect against CMV that is often associated with
clinical stabilization. Effectiveness of ganciclovir and foscarnet is correlated with weekly
maintenance and since toxicity is dose-limiting in up to 20 percent of patients receiving
either drug for long periods, it may be beneficial in long-term maintenance treatment to
combine or alternate these two drugs at a lower total weekly dose of each drug.
This strategy may result in a greater net antiviral effect with less toxicity than is seen
with either drug alone, because the toxicities of each drug are quite different.
A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS [Completed]
To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly
diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate
the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the
safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT).
(Patients utilizing treatment with other anti-retroviral drugs will be considered for study
entry on a case by case basis.) To determine survival in this group of patients with AIDS and