Cytogam (Cytomegalovirus Immune Globulin Intravenous (Human)) - Summary

CYTOGAM SUMMARY

CytoGam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV), is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV). CMV-IGIV is formulated in final vial as a sterile liquid. The globulin is stabilized with 5% sucrose and 1% Albumin (Human). CytoGam® contains no preservative. The purified immunoglobulin is derived from pooled adult human plasma selected for high titers of antibody for Cytomegalovirus (CMV) (1). Source material for fractionation may be obtained from another U.S. licensed manufacturer. Pooled plasma was fractionated by ethanol precipitation of the proteins according to Cohn Methods 6 and 9, modified to yield a product suitable for intravenous administration. A widely utilized solvent-detergent viral inactivation process is also used (2). Certain manufacturing operations may be performed by other firms. Each milliliter contains: 50 ± 10 mg of immunoglobulin, primarily IgG, and trace amounts of IgA and IgM; 50 mg of sucrose; 10 mg of Albumin (Human). The sodium content is 20-30 mEq per liter, i.e., 0.4-0.6 mEq per 20 mL or 1.0-1.5 mEq per 50 mL. The solution should appear colorless and translucent.

Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir.

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NEWS HIGHLIGHTS

Published Studies Related to Cytogam (Cytomegalovirus Immune Globulin)

Vaccine prevention of maternal cytomegalovirus infection. [2009.03.19]
BACKGROUND: Congenital infection with cytomegalovirus (CMV) is an important cause of hearing, cognitive, and motor impairments in newborns... CONCLUSIONS: CMV glycoprotein B vaccine has the potential to decrease incident cases of maternal and congenital CMV infection. (ClinicalTrials.gov number, NCT00125502.) 2009 Massachusetts Medical Society

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.

Role of cytomegalovirus in sensorineural hearing loss of children: a case-control study Tehran, Iran. [2008.02]
CONCLUSION: Cytomegalovirus is one of the most common infectious agents in SNHL children compared to the healthy children. Probably both congenital and acquired CMV can induce progressive hearing loss in our cases. We prefer at least in our country to consider seropositive (CMV-IgM) SNHL children (less than 1 year old) as congenital form. But we are not able to differentiate the congenital from the acquired infection in seropositive (CMV-IgM) SNHL children after first year of life. It should be subjected to randomized controlled trial for treatment of acquired type of CMV infection in SNHL children with ganciclovir.

Effects of Jinye Baidu Granule on fetal growth and development with maternal active human cytomegalovirus infection. [2006.12]
OBJECTIVE: To evaluate the effects of Jinye Baidu Granule ( JYBDG), a traditional Chinese medicine compound prescription, on fetal growth and development with maternal active human cytomegalovirus infection... CONCLUSION: JYBDG could decrease the intrauterine transmission of HCMV and is beneficial to fetal growth and development.

Safety and immunogenicity of Towne cytomegalovirus vaccine with or without adjuvant recombinant interleukin-12. [2006.06.19]
The Towne, human cytomegalovirus (CMV) vaccine is safe and immunogenic but has not prevented infection at doses tested to date. We administered 3000 pfu Towne CMV vaccine, with or without adjuvant recombinant interleukin-12 (rhIL-12), to CMV-seronegative healthy volunteers and then measured CMV gB-specific IgG titers and CMV-specific CD4+ and CD8+ T cell proliferation and IFNgamma expression after stimulation with whole viral lysate and immunodominant peptide CMV antigens...

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Clinical Trials Related to Cytogam (Cytomegalovirus Immune Globulin)

The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease [Active, not recruiting]
This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more effective in reducing the CMV viral load over time, as compared to standard treatment with IV ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®. Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable, whichever is longer duration.

Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection [Not yet recruiting]
The aim of this trial is to verify, under controlled conditions, the reported efficacy of human cytomegalovirus (HCMV)-specific hyperimmune globulin administration to pregnant women suffering from primary HCMV infection for the prevention of intrauterine HCMV transmission.

Study to Evaluate the Amount of Medications That May be Removed From the Body During Plasmapheresis [Recruiting]
Based on the limited amount of experience with plasmapheresis and CytoGam concomitant use, the researchers seek to evaluate the pharmacokinetics (drug absorption, distribution, and elimination) of this therapy. The researchers are also interested in evaluating the pharmacokinetics of the various immunosuppressant medications that patients will receive such as tacrolimus, mycophenolate mofetil and daclizumab.

Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients [Recruiting]
The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

Transfusion-Transmitted Cytomegalovirus Prevention in Neonates [Completed]

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