Gamimune N (Immune Globulin) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Antibodies in Gamimune N, 10% may interfere with the response to live viral vaccines such as measles, mumps and rubella. Therefore, use of such vaccines should be deferred until approximately 6 months after Gamimune N, 10% administration.

Please see DOSAGE AND ADMINISTRATION for other drug interactions.

CONTRAINDICATIONS

Gamimune N, 10% is contraindicated in individuals who are known to have had an anaphylactic or severe systemic response to Immune Globulin (Human). Individuals with selective IgA deficiencies who have known antibody against IgA (anti-IgA antibody) should not receive Gamimune N, 10% since these patients may experience severe reactions to the IgA which may be present.²²

REFERENCES

1. Tenold RA, inventor; Cutter Laboratories, assignee. Intravenously injectable immune serum globulin. U.S. Patent 4,396,608, Aug. 2, 1983.
2. Data on file at Bayer Corporation.
3. Pirofsky B, Campbell SM, Montanaro A: Individual patient variations in the kinetics of intravenous immunoglobulin administration. J Clin Immunol 2(2): 7S-14S, 1982.
4. Pirofsky B: Intravenous immune globulin therapy in hypogammaglobulinemia. Amer J Med 76(3A):53-60, 1984.
5. Pirofsky B, Anderson CJ, Bardana EJ Jr.: Therapeutic and detrimental effects of intravenous immunoglobulin therapy. In: Alving BM (ed.): Immunoglobulins: characteristics and uses of intravenous preparations. Washington, D.C., U.S. Government Printing Office, (1980), pp 15-22.
6. Sullivan KM, Kopecky KJ, Jocom J, et al: Immunomodulatory and antimicrobial efficacy of intravenous immunoglobulin in bone marrow transplantation. N Engl J Med 323(11):705-12, 1990.
7. Bernstein LJ, Ochs HD, Wedgwood RJ, et al; Defective humoral immunity in pediatric acquired immune deficiency syndrome. J Pediatr 107(3):352-7, 1985.
8. Borkowsky W, Steele CJ, Grubman S, et al: Antibody responses to bacterial toxoids in children infected with human immunodeficiency virus. J Pediatr 110(4):563-6, 1987.
9. Blanche S, Le Deist F, Fischer A, et al: Longitudinal study of 18 children with perinatal LAV/HTLV III infection: attempt at prognostic evaluation. J Pediatr 109(6):965-70, 1986.
10. Pahwa S, Fikrig S, Menez R, et al: Pediatric acquired immunodeficiency syndrome demonstration of B-lymphocyte defects in vitro. Diagn Immunol 4(1):24-30, 1986.
11. Bernstein LJ, Krieger BZ, Novick B, et al: Bacterial infections in the acquired immunodeficiency syndrome of children. Pediatr Infect Dis 4(5):472-5, 1985.
12. Krasinski K, Borkowsky W, Bonk S, et al: Bacterial infections in human immunodeficiency virus-infected children. Pediatr Infect Dis J 7(5):323-8, 1988.
13. Scott GB, Buck BE, Leterman JG, et al: Acquired immunodeficiency syndrome in infants. N Engl J Med 310(2):76-81, 1984.
14. Mofenson LM, Willoughby A. Passive immunization. In: Pizzo PA, Wilfert CM, (eds.) Pediatric AIDS: the challenge of HIV infection in infants, children and adolescents. Baltimore: Williams & Wilkins (1991) pp 633-50.
15. National Institute of Child Health and Human Development Intravenous Immunoglobulin Study Group. Intravenous immune globulin for the prevention of bacterial infections in children with symptomatic human immunodeficiency virus infection. N Engl J Med 325(2):73-80, 1991.
16. Mofenson LM, Moye J Jr, Bethel J, et al: Prophylactic intravenous immunoglobulin in HIV-infected children with CD4 + counts of 0.20 × 10⁹/L or more. Effect on viral, opportunistic, and bacterial infections. JAMA 268(4):483-88, 1992.
17. Glycine. In: Budavari S, O'Neil MJ, Smith A, et al, eds.: Merck Index. 11th ed. Rahway NJ, Merck & Co., 1989. p. 706.
18. Wretlind, A: Complete intravenous nutrition: theoretical and experimental background. Nutr Metab 14(Suppl):1-57, 1972.
19. Hahn RG, Stalberg HP, Gustafsson SA: Intravenous infusion of irrigating fluids containing glycine or mannitol with and without ethanol. J Urol 142(4):1102-1105, 1989.
20. Guyton AC: Textbook of Medical Physiology. 5th ed. Philadelphia, W.B. Saunders, 1976, pp 499-500.
21. Nolte MT, Pirofsky B, Gerritz GA, et al: Intravenous immunoglobulin therapy for antibody deficiency. Clin Exp Immunol 36: 237-43, 1979.
22. Buckley RH: Immunoglobulin replacement therapy: indications and contraindications for use and variable IgG levels achieved. In: Alving BM (ed): Immunoglobulins: characteristics and uses of intravenous preparations. Washington, D.C., U.S. Government Printing Office, (1980), pp 3-8.
23. Ochs HD: Intravenous immunoglobulin therapy of patients with primary immunodeficiency syndromes: efficacy and safety of a new modified immune globulin preparation. In: Alving BM (ed.): Immunoglobulins: characteristics and uses of intravenous preparations. Washington, D.C., U.S. Government Printing Office, (1980), pp 9-14.
24. Cayco AV, Perazella MA, Hayslett JP: Renal insufficiency after intravenous immune globulin therapy: A Report of Two Cases and an Analysis of the Literature. J Amer Soc Nephrology 8:1788-1793, 1997.
25. Sekul E, Cupler E, Dalakas M. Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: Frequency and risk factors. Ann Int Med 121:259-262, 1994.
26. Kato E, Shindo S, Eto Y, et al: Administration of Immune Globulin Associated with Aseptic Meningitis. JAMA 259(22):3269-3270, 1988.
27. Casteels-Van Daele M, Wijndaele L, Hunninck K, et al: Intravenous immune globulin and acute aseptic meningitis. N Engl J Med 323(9):614-615, 1990.
28. Scribner C, Kapit R, Phillips E, et al: Aseptic meningitis and Intravenous immunoglobulin therapy. Ann Intern Med 121(4):305-306, 1994.
29. Schiavotto C, Ruggeri M. Rodeghiero F. Adverse reactions after high-dose intravenous immunoglobulin: incidence in 83 patients treated for idiopathic thrombocytopenic purpura (ITP) and review of the literature. Haematologica 78(6:Suppl 2):35-40, 1993.
30. Pasatiempo AM, Kroser JA, Rudnick M, et al: Acute renal failure after intravenous immunoglobulin therapy. J Rheumatol 21(2):347-9, 1994.
31. Peerless AG, Stiehm ER: intravenous gammaglobulin for reaction to intramuscular preparation. [letter] Lancet 2(8347):461, 1983.
32. Winward DB, Brophy MT: Acute renal failure after administration of intravenous immunoglobulin: review of the literature and case report. Pharmacotherapy 15:765-772, 1995.
33. Phillips AO: Renal failure and intravenous immunoglobulin [letter; comment]. Clin Nephrol 36:83-86, 1992.
34. Anderson W, Bethea W: Renal lesions following administration of hypertonic solutions of sucrose. JAMA 114:1983-1987, 1940.
35. Lindberg H, Wald A: Renal changes following the administration of hypertonic solutions. Arch Intern Med 63:907-918, 1939.
36. Ridgon RH, Cardwell ES: Renal lesions following the intravenous injection of hypertonic solution of sucrose: A clinical and experimental study. Arch Intern Med 69:670-690, 1942.
37. Tan E, Hajinazarian M, Bay, et al. Acute renal failure resulting from intravenous immunoglobulin therapy. Arch Neurology 50:137-139, 1993.

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Pharmaceutical Division

Elkhart, IN 46515 USA 08692249

U.S. License No. 8 (Rev. November 2001)