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Atgam

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Atgam

Atgam®
(lymphocyte immune globulin, anti-thymocyte globulin [equine] sterile) Solution

For Intravenous Use Only

WARNING

Only physicians experienced in immunosuppressive therapy in the treatment of renal transplant or aplastic anemia patients should use ATGAM (lymphocyte immune globulin) .

Patients receiving ATGAM (lymphocyte immune globulin) should be treated in facilities equipped and staffed with adequate laboratory and supportive medical resources.

DRUG DESCRIPTION

ATGAM Sterile Solution contains lymphocyte immune globulin, anti-thymocyte globulin [equine]. It is the purified, concentrated, and sterile gamma globulin, primarily monomeric IgG, from hyperimmune serum of horses immunized with human thymus lymphocytes. ATGAM (lymphocyte immune globulin) is a transparent to slightly opalescent aqueous protein solution. It may appear colorless to faintly pink or brown and is nearly odorless. It may develop a slight granular or flaky deposit during storage. (For information about in-line filters, see Infusion Instructions in the DOSAGE AND ADMINISTRATION SECTION.)

Before release for clinical use, each lot of ATGAM (lymphocyte immune globulin) is tested to assure its ability to inhibit rosette formation between human peripheral lymphocytes and sheep red blood cells in vitro. In each lot, antibody activity against human red blood cells and platelets is also measured and determined to be within acceptable limits. Only lots that test negative for antihuman serum protein antibody, antiglomerular basement membrane antibody and pyrogens are released.

Each milliliter of ATGAM (lymphocyte immune globulin) contains 50 mg of horse gamma globulin stabilized in 0.3 molar glycine to a pH of approximately 6.8.

Last reviewed on RxList: 10/22/2008
This monograph has been modified to include the generic and brand name in many instances.

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