Atgam

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.