ADAGEN® (pegademase bovine) Injection is a clear, colorless, preservative free solution for intramuscular injection. ADAGEN® is supplied as a sterile solution in single-use vials containing 375 units per 1.5 mL solution, in boxes of 4 vials (NDC-57665-00101). Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration. Refrigerate. Store between +2°C and +8°C (36°F and 46°F). DO NOT FREEZE. ADAGEN® (pegademase bovine) Injection should not be stored at room temperature. This product should not be used if there are any indications that it may have been frozen. REFERENCES 1. Hershfield MS, Buckley RH, Greenberg ML, et al. Treatment of adenosine deaminase deficiency with polyethylene glycol-modified adenosine deaminase. N Engl J Med 1987; 316:589-96. 2. Levy Y, Hershfield MS, Fernandez-Mejia C, Polmar ST, Scudiery D, Berger M, Sorensen RU. Adenosine deaminase deficiency with late onset of recurrent infections: response to treatment with polyethylene glycolmodified adenosine deaminase. J Pediatr 1988; 113:312-17. 3. Kredich NM, Hershfield MS. Immunodeficiency diseases caused by adenosine deaminase deficiency and purine nucleoside phosphorylase deficiency. 6th ed. In: Scriver CR, Beaudet AL, Sly WS, Valle D, eds. The metabolic basis of inherited disease. New York: McGraw Hill, 1989; 1045-75. 4. Hirschhorn R. Inherited enzyme deficiencies and immunodeficiency: adenosine deaminase (ADA) and purine nucleoside phosphorylase (PNP) deficiencies. Clin Immunol Immunopathol 1986; 40:157-65. 5. Hirschhorn R, Roegner-Maniscalco V, Kuritsky L, Rosen FS. Bone marrow transplantation only partially restores purine metabolites to normal adenosine deaminase-deficient patients. J Clin Invest 1981; 68:1387-93. 6. Polmar AH, Stern RC, Schwartz AL, Wetzler EM, Chase PA, Hirschhorn R. Enzyme replacement therapy for adenosine deaminase deficiency and severe combined immunodeficiency. N Engl J Med 1976; 295:1337-43. 7. Rubinstein A, Hirschhorn R, Sicklick M, Murphy RA. In vivo and in vitro effects of thymosin and adenosine deaminase on adenosine-deaminase-deficient lymphocytes. N Engl J Med 1979; 300:387-92. 8. Hirschhorn R, Papageorgiou PS, Kesarwala HH, Taft LT. Amelioration of neurologic abnormalities after “enzyme replacement” in adenosine deaminase deficiency. N Engl J Med 1980; 303:377-80. 9. Hirschhorn R, Ratech H, Rubinstein A, et al. Increased excretion of modified adenine nucleosides by children with adenosine deaminase deficiency. Pediatr Res 1982; 16:362-9. 10.Polmar SH. Enzyme replacement and other biochemical approaches to the therapy of adenosine deaminase deficiency. In: Elliott K, Whelan J, eds. Enzyme defects and immune dysfunction. Amsterdam: Excerpta Medica, 1979; 213-30. Manufactured by Sigma-Tau PharmaSource, Inc., Indianapolis, IN 46268. Distributed by Sigma-Tau Pharmaceuticals, Inc., Gaithersburg, MD 20878. sigma-tau, Pharmaceuticas, Inc., Gaithersburg, MD 20878. Manufactured by: Sigma-tau pharmaceuticals Inc. Gaithersburg, MD 20878. Revised 2013 Last reviewed on RxList: 6/23/2014
This monograph has been modified to include the generic and brand name in many instances.