CYTOVENE-IV SUMMARY
CYTOVENE®-IV
(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.
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NEWS HIGHLIGHTS
Published Studies Related to Cytovene-IV (Ganciclovir)
Long-term outcomes of CMV disease treatment with valganciclovir versus IV ganciclovir in solid organ transplant recipients. [2009.05]
Though an important cause of morbidity and mortality in solid organ transplantation (SOT), the long-term outcomes of cytomegalovirus (CMV) disease treatment have not been well studied. In a randomized trial, 321 SOT recipients with CMV disease were followed 1 year after treatment with either twice daily intravenous ganciclovir or oral valganciclovir (for 21 days) followed by once daily valganciclovir until day 49 in all patients...
Effect on hearing of ganciclovir therapy for asymptomatic congenital cytomegalovirus infection: four to 10 year follow up. [2009.04]
BACKGROUND: Congenital cytomegalovirus infection is the leading identified nongenetic cause of congenital sensorineural hearing loss. Most of the infections are asymptomatic but may be detected from umbilical cord vein and/or newborn serum positivity for human cytomegalovirus immunoglobulin M, and from urine positivity (on polymerase chain reaction) for human cytomegalovirus deoxyribonucleic acid in the newborn period. Children infected by cytomegalovirus may later develop sensorineural hearing loss. In symptomatically infected infants, ganciclovir therapy administered in the neonatal period prevents hearing deterioration. However, preventative therapy of asymptomatic congenital cytomegalovirus disease with ganciclovir is controversial, as side effects such as severe neutropenia may occur during treatment... CONCLUSION: Asymptomatic congenital cytomegalovirus infection is likely to be a leading cause of sensorineural hearing loss in young children. Intravenous ganciclovir therapy seems to offer a medical option to prevent subsequent sensorineural hearing loss. Further studies including a greater number of children are needed. Cytomegalovirus screening models are mandatory if medical therapy is to be implemented in time.
Cytomegalovirus resistance in solid organ transplant recipients treated with intravenous ganciclovir or oral valganciclovir. [2009]
BACKGROUND: The rate of cytomegalovirus (CMV) mutations conferring ganciclovir resistance was assessed in a trial comparing intravenous ganciclovir and oral valganciclovir for treatment of CMV disease in solid organ transplant (SOT) recipients... CONCLUSIONS: Treatment with oral valganciclovir or intravenous ganciclovir results in similar and low rates of resistance mutations in SOT recipients. Patients with drug-resistant CMV strains often have virological failure and might have unfavourable clinical outcomes.
Valganciclovir for suppression of human herpesvirus-8 replication: a randomized, double-blind, placebo-controlled, crossover trial. [2008.07.01]
Background.@nbsp; Valganciclovir administered orally once per day is well tolerated and significantly reduces the frequency and quantity of HHV-8 replication.
Valganciclovir prevents cytomegalovirus reactivation in patients receiving alemtuzumab-based therapy. [2008.02.15]
Alemtuzumab is an immunosuppressive antibody that depletes normal T cells and B cells. Prophylaxis for herpes virus and Pneumocystis carinii is standard with this agent... In conclusion, this agent was highly effective for prophylaxis of CMV reactivation in patients receiving alemtuzumab.
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)
ganciclovir.
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
CMV retinitis.
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