Clinical Information
Gen. Code and Des.
34336 lymphocyte IG,antithymocyt,equ INTRAVEN AMPUL 50 MG/ML
GCN and Des.
43749 lymphocyte IG,antithymocyt,equ INTRAVEN AMPUL 50 MG/ML
Strength
50MG/ML
Dose Form
AMPUL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
92440000 IMMUNOSUPPRESSIVE AGENTS
Active Ingredients
3047 lymphocyte immune globulin,antithymocyte (equine) 308067609
ATGAM- equine thymocyte immune globulin injection, solution
Pharmacia and Upjohn Company
WARNING: ANAPHYLAXIS
Antithymocyte globulins can cause anaphylaxis when injected intravenously. Although ATGAM is processed to reduce the level of antibodies that will react to non-T cells, physicians should be prepared for the potential risk of anaphylaxis and monitor patients for signs and symptoms during infusion.
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 is transparent to slightly opalescent aqueous protein solution. It may appear colorless to faintly pink or brown and is nearly odorless. It may develop slight granular or flaky deposit during storag
Each milliliter of ATGAM contains 50 mg of horse gamma globulin stabilized in 0.3 molar glycine to pH of approximately 6.8.
Mechanism of Action
ATGAM is composed of antibodies that bind wide variety of proteins on the surface of lymphocytes. In addition, ATGAM binds to granulocytes, platelets, bone marrow cells, and other cell types. The mechanism of ATGAM-induced immunosuppression has not been determined. Published data indicate that the primary mechanism is the depletion of circulating lymphocytes, with greatest effect on lymphocytes. Lymphocyte depletion may be caused by complement dependent lysis and/or activation-induced apoptosis. In addition, immunosuppression may be mediated by the binding of antibodies to lymphocytes which results in partial activation and induction of lymphocyte anergy.
INDICATIONS AND USAGE
1.1 Renal Allograft Rejection
Renal transplant rejection: ATGAM is indicated for the management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection ATGAM increases the frequency of resolution of the acute rejection episode
1.2 Aplastic Anemia
ATGAM is indicated for the treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation.
The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, Fanconi?s syndrome, or in patients known to have been exposed to myelotoxic agents or radiation.
2 DOSAGE AND ADMINISTRATION
ATGAM is intended for intravenous use only.
ATGAM is used with concomitant immunosuppressants. During repeat courses of ATGAM, observe patients for signs of allergic reactions
2.1 Dose
Renal Allograft Recipients
Renal transplant rejection: The recommended dose is 10 to 15 mg/kg daily intravenously for 14 days. Additional alternate-day therapy up to total of 21 doses may be given.
Aplastic Anemia (Moderate to Severe)
The recommended dose is 10 to 20 mg/kg daily intravenously for to 14 days. Additional alternate-day therapy up to total of 21 doses may be given. Because thrombocytopenia can be associated with the administration of ATGAM, patients receiving it for the treatment of aplastic anemia may need prophylactic platelet transfusions to maintain platelets at clinically acceptable levels.
Geriatric population (?65 years of age)
Select the dose for an elderly patient with caution, starting at the low end of the dosage range
DOSAGE FORMS AND STRENGTHS
ATGAM 50 mg/mL concentrate for solution for infusio
CONTRAINDICATIONS
? Do not administer ATGAM to patient who has had systemic reaction (e.g., anaphylactic reaction) during prior administration of ATGAM or any other equine gamma globulin preparation.
HOW SUPPLIED/STORAGE AND HANDLING
ATGAM Sterile Solution, containing 50 mg/mL lymphocyte immune globulin, anti-thymocyte globulin [equine], is supplied as follows:
5 5 mL ampoules
NDC 0009-7224-02
Store in refrigerator at 2? to 8?C (36? to 46?F). DO NOT FREEZE
