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Cytogam ®

Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
Full Prescribing Information for Cytogam®        Important Safety Information

Cytogam is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV).

  • CMV-IGIV is formulated in final vial as a sterile liquid
  • The globulin is stabilized with 5% sucrose and 1% Albumin (Human)
  • Cytogam contains no preservative.

Diagnostic Codes (ICD-10-CM)

Billing Codes (HCPCS, NDC, CPT)

Medicare Part B ASP Pricing Limits

Authorized Distributors

Important Safety Information for Cytogam

Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human), is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas, and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients; prophylactic CMV-IGIV should be considered in combination with ganciclovir.

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. 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

Please see full prescribing information for Cytogam.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

CRP16-05-0001 05/2016
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