Cytogam^®: Reducing the risk in high-risk transplants for over 17 years

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

Alone or in combination with an antiviral agent, Cytogam^® has been shown to:

Reduce the risk of CMV-related disease and death in some of the highest-risk transplant patients^1,^2,^3,^4,⁵
Provide a measurable long-term survival benefit³
Produce minimal treatment-related side effects and adverse events

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. Valantine HA, Luikart H, Doyle R, et al. Impact of cytomegalovirus hyperimmune globulin on outcome after cardiothoracic transplantation: a comparative study of combined prophylaxis with CMV hyperimmune globulin plus ganciclovir versus ganciclovir alone. Transplantation. 2001;72:1647-52.

4. Ham JM, Shelden SL, Godkin RR, Posner MP, Fisher RA. Cytomegalovirus prophylaxis with ganciclovir, acyclovir, and CMV hyperimmune globulin in liver transplant patients receiving OKT3 induction. Transplant Proc. 1995;27(5)Suppl 1:31-3.

5. 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.

© 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.

Cytogam®: Reducing the risk in high-risk transplants for over 17 years

© 2008 CSL Behring

Important Safety Information

Cytogam^®: Reducing the risk in high-risk transplants for over 17 years