The safety profile of home infusion of intravenous immunoglobulin in patients with neuroimmunologic disorders

Journal of Clinical Neuromuscular Disease

Volumn 12, Issue SUPPL. 4, 2011, Pages

  Souayah, Nizar ^a   Hasan, Ashar ^b   Khan, Hafiz M R ^c   Yacoub, Hussam A ^a   Jafri, Mohsin ^d  

^a RUTGERS NEW JERSEY MEDICAL SCHOOL   (United States)

^b Walgreens Clinical Services   (United States)

^c FLORIDA INTERNATIONAL UNIVERSITY   (United States)

^d Des Moines University College of Osteopathic Medicine   (United States)

Author keywords

Adverse reactions; Home based infusion; Intravenous immunoglobulin; Neuroimmunological; Neuromuscular; Safety

Indexed keywords

DEXAMETHASONE; DIPHENHYDRAMINE; HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN; IMMUNOGLOBULIN G; PARACETAMOL;

ABSENCE OF SIDE EFFECTS; ADULT; ARTICLE; ASEPTIC MENINGITIS; BACKACHE; CARDIOVASCULAR DISEASE; CHILL; CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY; DEMYELINATING DISEASE; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG SAFETY; EATON LAMBERT SYNDROME; FATIGUE; FEMALE; GASTROINTESTINAL SYMPTOM; HOME CARE; HUMAN; IMMUNE DEFICIENCY; IMMUNOPATHOLOGY; INCIDENCE; INFUSION; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MOTOR NEUROPATHY; MULTIPLE SCLEROSIS; MYASTHENIA GRAVIS; MYOSITIS; NEUROIMMUNOLOGY; NEUROLOGIC DISEASE; PRIORITY JOURNAL; THROMBOEMBOLISM; UNSPECIFIED SIDE EFFECT; WEAKNESS;

AUTOIMMUNE DISEASES OF THE NERVOUS SYSTEM; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; HOME INFUSION THERAPY; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; INJECTIONS, INTRAVENOUS; PREMEDICATION; RETROSPECTIVE STUDIES;

EID: 79959282644     PISSN: 15220443     EISSN: 15371611     Source Type: Journal    
DOI: 10.1097/CND.0b013e3182212589     Document Type: Article

References (70)

1. Durandy A, Kaveri SV, Kuijpers TW, et al. Intravenous immunoglobulins - understanding properties and mechanisms. Clin Exp Immunol. 2009;158(suppl 1):2-13.
2. Jordan SC, Toyoda M, Vo AA. Intravenous immunoglobulin a natural regulator of immunity and inflammation. Transplantation. 2009;88:1-6.
3. Bruton OC. Agammaglobulinemia.Pediatrics. 1952;9:722-728.
4. Hartung HP, Mouthon L, Ahmed R, et al. Clinical applications of intravenous immunoglobulins (IVIg) - beyond immunodeficiencies and neurology. Clin Exp Immunol. 2009;158(suppl 1):23-33.
5. Imbach P, Barandun S, d'Apuzzo V, et al. High-dose intravenous gammaglobulin for idiopathic thrombocytopenic purpura in childhood. Lancet. 1981;1:1228-1231.
6. Linker RA, Gold R. Use of intravenous immunoglobulin and plasma exchange in neurological disease. Curr Opin Neurol. 2008;21:358-365. (Pubitemid 351653989)
7. Pohlau D, Przuntek H, Sailer M, et al. Intravenous immunoglobulin in primary and secondary chronic progressive multiple sclerosis: a randomized placebo controlled multicentre study. Mult Scler. 2007;13:1107-1117. (Pubitemid 351541414)
8. Dalakas MC. Intravenous immunoglobulin in autoimmune neuromuscular diseases. JAMA. 2004;291:2367-2375. (Pubitemid 38656304)
9. Dalakas MC. High-dose intravenous immunoglobulin in inflammatory myopathies: experience based on controlled clinical trials. Neurol Sci. 2003;24(suppl 4):S256-S259. (Pubitemid 37304335)
10. Van den Berg-Vos RM, Franssen H, Wokke JH, et al. Multifocal motor neuropathy: long-term clinical and electrophysiological assessment of intravenous immunoglobulin maintenance treatment. Brain. 2002;125:1875-1886.
11. Nobile-Orazio E, Bersano A. High-dose intravenous immunoglobulin therapy in dysimmune neuropathies. Neurol Sci. 2002;23(suppl 1):S25-S32. (Pubitemid 34568197)
12. Hughes RA. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy: the ICE trial. Expert Rev Neurother. 2009;9:789-795.
13. Eftimov F, Winer JB, Vermeulen M, et al. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2009:1:CD001797.
14. Feasby T, Banwell B, Benstead T, et al. Guidelines on the use of intravenous immune globulin for neurologic conditions. Transfus Med Rev. 2007;21:S57-S107. (Pubitemid 46509469)
15. Rigas M, Tandan R, Sterling RJ. Safety of liquid intravenous immunoglobulin for neuroimmunologic disorders in the home setting: a retrospective analysis of 1085 infusions. J Clin Neuromuscul Dis. 2008;10:52-55.
16. Orange JS, Hossny EM, Weiler CR, et al. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol. 2006;117:S525-S553.
17. Al-Wahadneh AM, Khriesat IA, Kuda EH. Adverse reactions of intravenous immunoglobulin. Saudi Med J. 2000;21:953-956.
18. Orbach H, Katz U, Sherer Y, et al. Intravenous immunoglobulin: adverse effects and safe administration. Clin Rev Allergy Immunol. 2005;29:173-184. (Pubitemid 43041668)
19. Stangel M, Muller M, Marx P. Adverse events during treatment with high-dose intravenous immunoglobulins for neurological disorders. Eur Neurol. 1998;40:173-174. (Pubitemid 28466711)
20. Brannagan TH III, Nagle KJ, Lange DJ, et al. Complications of intravenous immune globulin treatment in neurologic disease. Neurology. 1996;47:674-677. (Pubitemid 26307296)
21. Bertorini TE, Nance AM, Horner LH, et al. Complications of intravenous gammaglobulin in neuromuscular and other diseases. Muscle Nerve. 1996;19:388-391. (Pubitemid 26069376)
22. Cowden J, Parker SK. Intravenous immunoglobulin: production, uses and side effects. Pediatr Infect Dis J. 2006;25:641-642. (Pubitemid 43995363)
23. Misbah SA, Chapel HM. Adverse effects of intravenous immunoglobulin. Drug Saf. 1993;9:254-262. (Pubitemid 23302151)
24. Sherer Y, Levy Y, Langevitz P, et al. Adverse effects of intravenous immunoglobulin therapy in 56 patients with autoimmune diseases. Pharmacology. 2001;62:133-137. (Pubitemid 32260852)
25. Hamrock DJ. Adverse events associated with intravenous immunoglobulin therapy. Int Immunopharmacol. 2006;6:535-542.
26. Stangel M, Kiefer R, Pette M, et al. Side effects of intravenous immunoglobulins in neurological autoimmune disorders - a prospective study. J Neurol. 2003;250:818-821. (Pubitemid 36898113)
27. Stangel M, Hartung HP, Marx P, et al. Side effects of high-dose intravenous immunoglobulins. Clin Neuropharmacol. 1997;20:385-393. (Pubitemid 27424328)
28. Sekul EA, Cupler EJ, Dalakas MC. Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: frequency and risk factors. Ann Intern Med. 1994;121:259-262.
29. Schiff RI, Williams LW, Nelson RP, et al. Multicenter crossover comparison of the safety and efficacy of Intraglobin-F with Gamimune-N, Sandoglobulin, and Gammagard in patients with primary immunodeficiency diseases. J Clin Immunol. 1997;17:21-28. (Pubitemid 27083451)
30. Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Transfus Med Rev. 2003;17:241-251. (Pubitemid 37310931)
31. Orbach H, Tishler M, Shoenfeld Y. Intravenous immunoglobulin and the kidney-a two-edged sword. Semin Arthritis Rheum. 2004;34:593-601. (Pubitemid 39643121)
32. Grenouillet-Delacrea M, Longy-Boursier M. Human immunoglobulins, adverse drug reaction, prevention. [French]. Rev Med Interne. 2008;29:24-28.
33. Wright SE, Shaikh ZH, Castillo-Lugo JA, et al. Aseptic meningitis and abducens nerve palsy as a serious side effect of high dose intravenous immunoglobulin used in a patient with renal transplantation. Transpl Infect Dis. 2008;10:294-297. (Pubitemid 352040434)
34. Wajanaponsan N, Cheng SF. Acute renal failure resulting from intravenous immunoglobulin therapy. Hawaii Med J. 2004;63:266-267.
35. Warrier I, Bussel JB, Valdez L, et al. Safety and efficacy of low-dose intravenous immune globulin (IVIG) treatment for infants and children with immune thrombocytopenic purpura. Low-Dose IVIG Study Group. J Pediatr Hematol Oncol. 1997;19:197-201. (Pubitemid 27276284)
36. Brennan VM, Cochrane S, Fletcher C, et al. Surveillance of adverse reactions in patients self-infusing intravenous immunoglobulin at home. J Clin Immunol. 1995;15:116-119.
37. Gardulf A, Hammarstrom L, Smith CI. Home treatment of hypogammaglobulinaemia with subcutaneous gammaglobulin by rapid infusion. Lancet. 1991;338:162-166.
38. Kobayashi RH, Kobayashi AD, Lee N, et al. Home self-administration of intravenous immunoglobulin therapy in children. Pediatrics. 1990;85:705-709. (Pubitemid 20144836)
39. Chapel H, Brennan V, Delson E. Immunoglobulin replacement therapy by self-infusion at home. Clin Exp Immunol. 1988;73:160-162.
40. Hachulla E, Wibaux A, Hatron PY, et al. Home sequential high dose intravenous immunoglobulins in systemic autoimmune disease. Ann Rheum Dis. 2002;61:277-278. (Pubitemid 34177767)
41. Murphy E, Martin S, Patterson JV. Developing practice guidelines for the administration of intravenous immunoglobulin. J Infus Nurs. 2005;28:265-272. (Pubitemid 41076999)
42. Nydegger UE, Sturzenegger M. Adverse effects of intravenous immunoglobulin therapy. Drug Saf. 1999; 21:171-185. (Pubitemid 29427880)
43. Gurcan HM, Ahmed AR. Efficacy of various intravenous immunoglobulin therapy protocols in autoimmune and chronic inflammatory disorders. Ann Pharmacother. 2007;41:812-823. (Pubitemid 46752660)
44. Paran D, Herishanu Y, Elkayam O, et al. Venous and arterial thrombosis following administration of intravenous immunoglobulins. Blood Coagul Fibrinolysis. 2005;16:313-318. (Pubitemid 41008736)
45. Marie I, Herve F, Kerleau JM, et al. Intravenous immunoglobulin- associated vena cava thrombosis. Thromb Haemost. 2006;96:849-851. (Pubitemid 44883829)
46. Marie I, Maurey G, Herve F, et al. Intravenous immunoglobulin-associated arterial and venous thrombosis; report of a series and review of the literature. Br J Dermatol. 2006;155:714-721. (Pubitemid 44352551)
47. Katz U, Shoenfeld Y. Review: intravenous immunoglobulin therapy and thromboembolic complications. Lupus. 2005;14:802-808. (Pubitemid 41597614)
48. Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology. 1994;44:223-226. (Pubitemid 24070955)
49. Vecchietti G, Kerl K, Prins C, et al. Severe eczematous skin reaction after high-dose intravenous immunoglobulin infusion: report of 4 cases and review of the literature. Arch Dermatol. 2006;142:213-217. (Pubitemid 43276534)
50. Yockey SM, Ahmed I. Intravenous immunoglobulin-induced lichenoid dermatitis: a unique adverse reaction. Mayo Clin Proc. 1997;72:1151-1152.
51. Barbaud A, Trechot P, Granel F, et al. A baboon syndrome induced by intravenous human immunoglobulins: report of a case and immunological analysis. Dermatology. 1999;199:258-260.
52. Barucha C, McMillan JC. Eczema after intravenous infusion of immunoglobulin. Br Med J (Clin Res Ed). 1987;295:1141. (Pubitemid 17151288)
53. Chan-Lam D, Fitzsimons EJ, Douglas WS. Alopecia after immunoglobulin infusion. Lancet. 1987;1:1436. (Pubitemid 17078891)
54. 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. 1993;78:35-40.
55. Rault R, Piraino B, Johnston JR, et al. Pulmonary and renal toxicity of intravenous immunoglobulin. Clin Nephrol. 1991;36:83-86.
56. Tan E, Hajinazarian M, Bay W, et al. Acute renal failure resulting from intravenous immunoglobulin therapy. Arch Neurol. 1993;50:137-139. (Pubitemid 23054794)
57. Gras V, Andrejak M, Decocq G. Acute renal failure associated with intravenous immunoglobulins. Pharmacoepidemiol Drug Saf. 1999;8(suppl 1):S73-S78. (Pubitemid 29201778)
58. Fakhouri F. Intravenous immunoglobulins and acute renal failure: mechanism and prevention. Rev Med Interne. [French]. 2007;28:4-6.
59. McRogers R. Not all intravenous immunoglobulins are the same: appropriate selection in patients with compromised renal function. Pharmacotherapy. 2006;26:296-297. (Pubitemid 43201880)
60. Itkin YM, Trujillo TC. Intravenous immunoglobulin-associated acute renal failure: case series and literature review. Pharmacotherapy. 2005;25:886-892. (Pubitemid 40727141)
61. Renal insufficiency and failure associated with immune globulin intravenous therapy - United States, 1985-1998. MMWR Morb Mortal Wkly Rep. 1999;48:518-521.
62. Haskin JA, Warner DJ, Blank DU. Acute renal failure after large doses of intravenous immune globulin. Ann Pharmacother. 1999;33:800-803. (Pubitemid 29387658)
63. Burks AW, Sampson HA, Buckley RH. Anaphylactic reactions after gamma globulin administration in patients with hypogammaglobulinemia. Detection of IgE antibodies to IgA. N Engl J Med. 1986;314:560-564. (Pubitemid 16128065)
64. Ahsan N, Wiegand LA, Abendroth CS, et al. Acute renal failure following immunoglobulin therapy. Am J Nephrol. 1996;16:532-536. (Pubitemid 26387941)
65. Cantu TG, Hoehn-Saric EW, Burgess KM, et al. Acute renal failure associated with immunoglobulin therapy. Am J Kidney Dis. 1995;25:228-234.
66. Hansen-Schmidt S, Silomon J, Keller F. Osmotic nephrosis due to high-dose immunoglobulin therapy containing sucrose (but not with glycine) in a patient with immunoglobulin A nephritis. Am J Kidney Dis. 1996;28:451-453. (Pubitemid 26304427)
67. de Albuquerque Campos R, Sato MN, da Silva Duarte AJ. da Silva Duarte AJ. IgG anti-IgA subclasses in common variable immunodeficiency and association with severe adverse reactions to intravenous immunoglobulin therapy. J Clin Immunol. 2000;20:77-82. (Pubitemid 30210110)
68. Bjorkander J, Hammarstrom L, Smith CI, et al. Immunoglobulin prophylaxis in patients with antibody deficiency syndromes and anti-IgA antibodies. J Clin Immunol. 1987;7:8-15. (Pubitemid 17028769)
69. McCluskey DR, Boyd NA. Anaphylaxis with intravenous gammaglobulin. Lancet. 1990;336:874. (Pubitemid 20311357)
70. Bagdasarian A, Tonetta S, Harel W, et al. IVIG adverse reactions: potential role of cytokines and vasoactive substances. Vox Sang. 1998;74:74-82. (Pubitemid 28052448)