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ATGAM (lymphocyte immune globulin) Sterile Solution is a lymphocyte-selective immunosuppressant as is demonstrated by its ability to reduce the number of circulating, thymus-dependent lymphocytes that form rosettes with sheep erythrocytes. This antilymphocytic effect is believed to reflect an alteration of the function of the T lymphocytes, which are responsible in part for cell-mediated immunity and are involved in humoral immunity. In addition to its antilymphocytic activity, ATGAM (lymphocyte immune globulin) contains low concentrations of antibodies against other formed elements of the blood. In rhesus and cynomolgus monkeys, ATGAM (lymphocyte immune globulin) reduces lymphocytes in the thymus-dependent areas of the spleen and lymph nodes. It also decreases the circulating sheep-erythrocyte-rosetting lymphocytes that can be detected, but ordinarily ATGAM (lymphocyte immune globulin) does not cause severe lymphopenia.
In general, when ATGAM (lymphocyte immune globulin) is given with other immunosuppressive therapy, such as antimetabolites and corticosteroids, the patient's own antibody response to horse gamma globulin is minimal. In a small clinical study, ATGAM (lymphocyte immune globulin) administered with other immunosuppressive therapy and measured as horse IgG had a serum half-life of 5.7±3 days.
During the development of ATGAM (lymphocyte immune globulin) Sterile Solution, aliquots of the various clinical lots were infused intravenously in either Macaca mulatta or Macaca irus monkeys. The dosage used was 100 mg/kg on day 0, 200 mg/kg on day 2, and 400 mg/kg on day 4. A 3-week observation period followed.
Many of the changes observed could have been anticipated on the basis of the antilymphocytic activity of ATGAM (lymphocyte immune globulin) . They are decreased peripheral blood lymphocytes and increased total leukocyte and neutrophil counts occurring within 24 hours after infusion, decreased thymus size with involution or atrophy, or both, and decreased lymphocyte populations in the thymus-dependent areas of the spleen and lymph nodes. The atrophy was particularly common in the animals receiving the higher doses. In animals receiving either dosage regimen, packed cell volume, total erythrocyte counts, and hemoglobin concentrations have decreased and reticulocytes and nucleated erythrocytes have increased enough to be classified as anemia. An occasional animal death believed to have resulted from anemia has occurred. Transient decreases in blood platelet counts have also occurred. Thrombus formation occurred frequently along the routes of infusion, ie, the saphenous and femoral veins. However, the incidence of thrombi has dropped since in-line filters have been used during infusion. In these animals, definitive evidence of DIC (disseminated intravascular coagulation) has not been observed.
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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