Outcome in heart-lung and lung transplant patients at 3 years after transplant¹

CMV infection poses particularly high-risk for heart-lung and lung transplant patients due to the potential for CMV disease to cause obliterative bronchiolitis or result in loss of the lung allograft¹. In a study of heart-lung and lung transplant patients receiving Cytogam^® and ganciclovir, compared to matched historical controls, clinicians found that patients receiving combination therapy experienced the following¹:

Lower incidence of obliterative bronchiolitis
Lower incidence of death from obliterative bronchiolitis
Significantly longer survival (79% survival at 3 years, vs 55% of those treated with ganciclovir alone)¹
Significantly higher rejection-free rates and CMV-disease-free status over 3 years post-transplant¹

* Note to users of Valcyte^® (valganciclovir), the prodrug of ganciclovir: After oral administration, the diasteromers of Valcyte are rapidly converted to ganciclovir by intestinal and hepatic esterases.

Valcyte is a registered trademark of Roche Pharmaceuticals.

Outcome in heart-lung and lung tranplant patients at 3 years after transplant

1. 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.

© 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.

Outcome in heart-lung and lung transplant patients at 3 years after transplant1

© 2008 CSL Behring

Important Safety Information

Outcome in heart-lung and lung transplant patients at 3 years after transplant¹