Solid organ transplant recipients are at serious risk of CMV infection

Cytomegalovirus (CMV) is the most common and single most important viral infection in solid organ transplant recipients.^1,²

Symptomatic disease occurs in approximately 39% of lung, 25% of heart, 29% of liver, up to 50% of kidney-pancreas, and 8% of renal transplant recipients not receiving antiviral prophylaxis.³

The risk of developing symptomatic CMV disease is highest in D+/R– individuals and among patients treated with antilymphocyte antibody immunosuppressive agents.⁴

Cytomegalovirus (CMV) infection usually develops during the first few months after transplantation⁴ and is sometimes associated with clinical infectious disease and acute and/or chronic graft injury and dysfunction.⁵

In addition to causing febrile illness and organ invasion syndromes in solid organ transplant recipients, CMV indirectly influences other clinically and economically relevant outcomes such as reduced patient and graft survival, increased incidence of bacterial and fungal infections, and increased cost and resource utilization.⁶

Consequent to the widespread use of antiviral prophylaxis and preemptive therapy, there has been a significant reduction in the incidence and severity of CMV disease and its indirect effects.⁵

1. Snydman DR, Werner BG, Heinze-Lacey B, et al. Use of cytomegalovirus immune globulin to prevent cytomegalovirus disease in renal-transplant recipients. N Engl J Med. 1987;317:1049-54.

2. Snydman DR, Werner BG, Dougherty NN, et al. Cytomegalovirus immune globulin prophylaxis in liver transplantation. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1993;119:984-91.

3. Patel R, Paya CV. Infections in solid-organ transplant recipients. Clin Microbiol Rev. 1997;10(1):86-124.

4. McDevitt LM. Etiology and impact of cytomegalovirus disease on solid organ transplant recipients. Am J Health-Syst Pharm. 2001:63(1)(Suppl 5):S3-S9.

5. Fishman JA, Emery V, Freeman R, et al. Cytomegalovirus in transplantation—challenging the status quo. Clin Transplant. 2007;21:149-58.

6. Razonable RR. Epidemiology of cytomegalovirus disease in solid organ and hematopoietic stem cell transplant recipients. Am J Health Syst Pharm. Apr 15 2005;62(8 Suppl 1):S7-13.

© 2008 CSL Behring

Important Safety Information

Cytogam^® is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart.

Cytogam^® is contraindicated in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations and in persons with selective immunoglobulin A deficiency who have known antibodies to IgA.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients predisposed to acute renal failure include patients with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentrations available and the minimum rate of infusion practicable.

Increases in serum creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following IGIV infusion. Progression to oliguria or anuria requiring dialysis has been observed.

Cytogam^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Minor reactions, such as flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing, were the most frequent adverse reactions observed during the clinical trials for Cytogam^®.

For more information about Cytogam^®, please see the full prescribing information.

Cytogam^® is a registered trademark of CSL Behring AG.