Cytogam^® offers extra protection and proven safety to high-risk kidney transplant recipients

Analysis of virologically confirmed CMV and associated syndromes¹

In a prospective randomized controlled trial, D+R- kidney transplant patients received either CMVIG (n=24) or no specific CMV prophylaxis (n=35). CMVIG was administered 72 hours after transplant, then every two weeks for 16 weeks¹. The following results were noted:

Virologically confirmed CMV syndrome occurred in 60% of controls but only 21% of those treated with Cytogam^® in the randomized study¹
~ Acquired leukopenia: 4% (Cytogam^®) vs 37% (controls) (P=<0.01)
~ CMV pneumonia reduced 80% in Cytogam^®-treated patients
Only 13% of patients receiving Cytogam^® had serious disease, compared to 46% of controls¹
Only 6% of infusions were associated with possible side effects, and it was not necessary to stop therapy due to any of these reactions¹

Analysis of virologically confirmed CMV and associated syndromes

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.

© 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® offers extra protection and proven safety to high-risk kidney transplant recipients

© 2008 CSL Behring

Important Safety Information

Cytogam^® offers extra protection and proven safety to high-risk kidney transplant recipients