Proven safety profile with 17-year safety database (1991–2007)

As shown in the table below, Cytogam^® safety data were reported by Snydman et al. for two studies of kidney transplant recipients and one study of liver transplant recipients.^1,^2,³ A total of 157 patients receiving Cytogam^® treatment received a total of 1044 infusions, with 62 infusions (5.9%) in 42 patients involving effects potentially attributable to the treatment. In only 1 of the 1044 infusions was the effect (hemolysis) severe enough for the infusion to be discontinued.

For detailed information about potential adverse events related to Cytogam^® use, please see the Important Safety Information below or click here for the full Prescribing Information.

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, Tilney NL, et al. Final analysis of primary cytomegalovirus disease prevention in renal transplant recipients with a cytomegalovirus-immune globulin: comparison of the randomized and open-label trials. Transplant Proc. 1991;23:1357-60.

3. 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.