Risk factors for development of CMV Infection and Disease

CMV infection is distinct from CMV disease. Infection is defined as isolation of CMV, evidence of viral antigens or viral DNA from a patient's body fluids or tissues. In contrast, CMV disease–for example, pneumonia, colitis, or hepatitis– is recognized by the symptoms of tissue injury in combination with evidence of CMV infection.¹

Approximately 50%-75% of organ transplant patients have some evidence of active CMV infection in the first year following transplant.^2,3 Whether or not clinical disease develops depends on the interaction of the immunosuppressive regimen, the level of the virus that is achieved, and the state of the patient's immunity against the virus.⁴

The chart below shows the hierarchy of risk factors based on

Risk factors for development of CMV Infection and Disease Patient-Specific Risk Factors

* Campath and Thymoglobulin are manufactured by Genzyme Corporation

*	D+	=	Donor positive CMV
	R+	=	Recipient positive for CMV
	D-	=	Donor negative CMV
	R-	=	Recipient negative for CMV

1. Kotton CN, Fishman JA. Viral infection in the renal transplant recipient. J Am Soc Nephrol. 2005;16(6):1758-74.

2. Hodson EM, Jones CA, Webster AC, Strappoli GFM, et al. Antiviral medications to prevent cytomegalovirus disease and early death in recipients of solid-organ transplants: a systematic review of randomised controlled trials. Lancet. 2005;365:2105-2115.

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

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. 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.

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.

7. Sia I, Patel R. New strategies for prevention and therapy of Cytomegalovirus infection and disease in solid-organ transplant recipients. Clin Micro Rev, January 2000; 86-8.

© 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.