Gammagard S / D (Immune Globulin Intravenous) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

See DOSAGE AND ADMINISTRATION section.

CONTRAINDICATIONS

Patients may experience severe hypersensitivity reactions or anaphylaxis in the setting of detectable IgA levels following infusion of GAMMAGARD S/D. The occurrence of severe hypersensitivity reactions or anaphylaxis under such conditions should prompt consideration of an alternative therapy. GAMMAGARD S/D is contraindicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern (see INDICATIONS AND USAGE and WARNINGS sections).

REFERENCES

1. Prince AM, Horowitz B, Brotman B: Sterilisation of hepatitis and HTLV-III viruses by exposure to tri-n-butyl phosphate and sodium cholate. Lancet 1: 706-710, 1986
2. Horowitz B, Wiebe ME, Lippin A, et al: Inactivation of viruses in labile blood derivatives: I. Disruption of lipid enveloped viruses by tri-n-butyl phosphate detergent combinations. Transfusion 25: 516-522, 1985
3. Unpublished data in the files of Baxter Healthcare Corporation
4. Waldmann TA, Storber W: Metabolism of immunoglobulins. Prog Allergy 13: 1-110, 1969
5. Morell A, Riesen W: Structure, function and catabolism of immuno-globulins in Immunohemotherapy. Nydegger UE (ed), London, Academic Press, 1981, pp 17-26
6. Stiehm ER: Standard and special human immune serum globulins as therapeutic agents. Pediatrics 63: 301-319, 1979
7. Buckley RH: Immunoglobulin replacement therapy: Indications and contraindications for use and variable IgG levels achieved in Immunoglobulins: Characteristics and Use of Intravenous Preparations. Alving BM, Finlayson JS (eds), Washington, DC, U.S. Department of Health and Human Services, 1979, pp 3-8
8. Bunch C, Chapel HM, Rai K, et al: Intravenous Immune Globulin reduces bacterial infections in Chronic Lymphocytic Leukemia: A controlled randomized clinical trial. Blood 70 Suppl 1: 753, 1987
9. Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia: Intravenous immunoglobulin for the prevention of infection in Chronic Lymphocytic Leukemia: A randomized, controlled clinical trial. N Eng J Med 319: 902-907, 1988
10. Newburger J, Takahashi M, Burns JG, et al: The Treatment of Kawasaki Syndrome with Intravenous Gamma Globulin. New England Journal of Medicine 315: 341-347, 1986
11. Furusho K, Sato K, Soeda T, et al: High Dose Intravenous Gammaglobulin for Kawasaki Disease [letter]. Lancet 2: 1359, 1983
12. Nagashima M, Matsushima M, Matsucka H, Ogawa A, Okumura N: High Dose Gammaglobulin Therapy for Kawasaki Disease. Journal of Pediatrics 110: 710-712, 1987.
13. Data in the files of Baxter Healthcare Corporation
14. Furusho K, Hroyuki N, Shinomiya K, et al: High Dose Intravenous Gammaglobulin for Kawasaki Disease. Lancet 2: 1055-1058, 1984
15. Engle MA, Fatica NS, Bussel JB, O'Laughlin JE, Snyder MS, Lesser ML: Clinical Trial of Single-Dose Intravenous Gammaglobulin in Acute Kawasaki Disease. AJDC143: 1300-1304, 1989
16. Isawa M, Sugiyama K, Kawase A, et al: Prevention of Coronary Artery Involvement in Kawasaki Disease by Early Intravenous High Dose Gammaglobulin. In: Doyle EF, Engle MA, Gersony WM, Rashkind EJ, Talner NS, eds Pediatric Cardiology. New York: Springer-Verlag, 1986:1083-1085
17. Okuri M, Harada K, Yamaguchi H, et al: Intravenous Gammaglobulin Therapy in Kawasaki Disease: Trial of Low-Dose Gammaglobulin. In: Shulman ST, ed. Kawasaki Disease. New York: Alan R. Liss, 1987:433-439
18. Cayco AV, Perazella MA, Hayslett JP: Renal insufficiency after intravenous immune globulin therapy: A Report of Two Cases and an Analysis of the Literature. 1997; J Amer Soc Nephrology 8: 1788-1793
19. Burks AW, Sampson HA, Buckley RH: Anaphylactic reactions after gammaglobulin administration in patients with hypogammaglobulinemia: Detection of IgE antibodies to IgA. N Eng J Med 314: 560-564, 1986
20. Reinhart WH, Berchtold PE: Effect of high-dose intravenous immunoglobulin therapy on blood rheology. Lancet 339 (8794): 662-664, 1992
21. Dalakas MC: High-dose intravenous immunoglobulin and serum viscosity: Risk of precipitating thromboembolic events. Neurology 44 (2): 223-226, 1994
22. Harkness K, Howell SJL, Davies-Jones GAB: Encephalopathy associated with intravenous immunoglobulin treatment for Guillain-Barre syndrome. Journal of Neurology Neurosurgery, Psychiatry 60 (5): 586-598, 1996
23. Woodruff RK, Grigg AP, Firkin FC, Smith IL: Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients. Lancet ii (8500): 217-218, 1986
24. Silbert PL, Knezevic WV, Bridge DT: Cerebral infarction complicating intravenous immunoglobulin therapy for polyneuritis cranialis. Neurology 42 (1): 257-258, 1992
25. Duhem C, Dicato MA, Ries F: Side effects of intravenous immune globulins. Clin Exp Immunol 97: (Suppl 1) 79-83, 1994
26. Winward DB, Brophy MT: Acute renal failure after administration of intravenous immunoglobulin: review of the literature and case report. 1995; Pharmacotherapy 15: 765-772
27. Phillips AO: Renal failure and intravenous immunoglobulin [letter, comment]. 1992; Clin Nephrol 36: 83-86
28. Anderson W, Bethea W: Renal lesions following administration of hypertonic solutions of sucrose. 1940; JAMA 114: 1983-1987
29. Lindberg H, Wald A: Renal changes following the administration of hypertonic solutions. 1939; Arch Intern Med 63: 907-918
30. Rigdon RH, Cardwell ES: Renal lesions following the intravenous injection of hypertonic solution of sucrose: A clinical and experimental study. 1942; Arch Intern Med 69: 670-690
31. Ochs HD, Lee ML, Fischer SH, et al: Efficacy of a New Intravenous Immunoglobulin Preparation in Primary Immunodeficient Patients. Clinical Therapeutics 9: 512-522, 1987
32. Tan E, Hajinazarian M, Bay, et al: Acute renal failure resulting from intravenous immunoglobulin therapy. 1993; Arch Neurology 50: 137-139
33. Brannagan TH 3rd, Nagle KJ, Lange DJ, Rowland LP: Complications of intravenous immune globulin treatment in neurologic disease. Neurology 47 (3): 674-677, 1996
34. Haplea SS, Farrar JT, Gibson GA, Laskin M, Pizzi LT, Ashbury AK: Thromboembolic Events Associated with Intravenous Immunoglobulin Therapy: Neurology 48: A54, 1997
35. Kwan T, and Keith P: Stroke Following Intravenous Immunoglobulin Infusion in a 28-Year-Old Male with Common Variable Immune Deficiency: A Case Report and Literature Review. Canadian Journal of Allergy & Clinical Immunology 4: 250-253, 1999
36. Elkayam O, Paran D, Milo R, Davidovitz Y, Almoznino-Sarafian D, Zelster D, Yaron M, Caspi D: Acute Myocardial Infarction Associated with High Dose Intravenous Immunoglobulin Infusion for Autoimmune Disorders. A study of four cases. Ann Rheum Dis 59 (1): 77-80, 2000
37. Grillo JA, Gorson KC, Ropper AH, Lewis J, Weinstein R: Rapid infusion of intravenous immune globulin in patients with neuromuscular disorders. Neurology 57(9): 1699-1701, 2001
38. Gomperts ED, Darr F: Letter to the Editor: Reference article - Rapid infusion of intravenous immune globulin in patients with neuromuscular disorders. Neurology, 2002. In Press

BIBLIOGRAPHY

Bussel JB, Kimberly RP, Inman RD, et al: Intravenous gammaglobulin treatment of chronic idiopathic thrombocytopenic purpura. Blood 62: 480-486, 1983

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