Management of adverse events in the treatment of patients with immunoglobulin therapy: A review of evidence

Autoimmunity Reviews

Volumn 15, Issue 1, 2016, Pages 71-81

  Cherin, Patrick ^a   Marie, Isabelle ^b   Michallet, Mauricette ^c   Pelus, Eric ^d   Dantal, Jacques ^e   Crave, Jean Charles ^f   Delain, Jean Christophe ^f   Viallard, Jean François ^g  

^a PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^b ROUEN UNIVERSITY HOSPITAL   (France)

^c CENTRE HOSPITALIER LYON SUD   (France)

^d Hôpitaux Civils de Colmar   (France)

^e HÔTEL DIEU   (France)

^f Octapharma   (France)

^g BORDEAUX UNIVERSITY HOSPITAL   (France)

Author keywords

Adverse event management; Clinical practice; Immunoglobulin; Level of evidence; Premedication; Product selection; Safety

Indexed keywords

ANTIHISTAMINIC AGENT; IMMUNOGLOBULIN; IMMUNOGLOBULIN A; PARACETAMOL; STEROID;

ADVERSE DRUG REACTION; AGING; ANAPHYLAXIS; ARTHRALGIA; ASEPTIC MENINGITIS; AUTOIMMUNE DISEASE; BACKACHE; CEREBROVASCULAR ACCIDENT; CHILL; DEEP VEIN THROMBOSIS; DIARRHEA; DYSPNEA; FATIGUE; FEVER; HEADACHE; HEART INFARCTION; HEMOLYSIS; HUMAN; HYPONATREMIA; IMMUNE DEFICIENCY; IMMUNOTHERAPY; INCIDENCE; INFECTION RISK; KIDNEY FAILURE; LUNG EMBOLISM; MALAISE; MIGRAINE; MYALGIA; NAUSEA; NEUTROPENIA; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK FACTOR; SKIN MANIFESTATION; SUBSTITUTION THERAPY; TACHYCARDIA; THORAX PAIN; THROMBOSIS; TRANSFUSION RELATED ACUTE LUNG INJURY; TREATMENT INDICATION; VOMITING; ADVERSE EFFECTS; AUTOIMMUNE DISEASES; IMMUNOLOGIC DEFICIENCY SYNDROMES; PASSIVE IMMUNIZATION;

AUTOIMMUNE DISEASES; HUMANS; IMMUNIZATION, PASSIVE; IMMUNOGLOBULINS, INTRAVENOUS; IMMUNOLOGIC DEFICIENCY SYNDROMES;

EID: 84955175424     PISSN: 15689972     EISSN: 18730183     Source Type: Journal    
DOI: 10.1016/j.autrev.2015.09.002     Document Type: Review

References (172)

1. Eibl M.M. History of immunoglobulin replacement. Immunol Allergy Clin North Am 2008, 28:737-764. [viii].
2. Orange J.S., Hossny E.M., Weiler C.R., Ballow M., Berger M., Bonilla FA., 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:S525-553.
3. Ammann A.J., Ashman R.F., Buckley R.H., Hardie WR., Krantmann HJ., Nelson J., et al. Use of intravenous gamma-globulin in antibody immunodeficiency: results of a multicenter controlled trial. Clin Immunol Immunopathol 1982, 22:60-67.
4. Buckley R.H., Schiff R.I. The use of intravenous immune globulin in immunodeficiency diseases. N Engl J Med 1991, 325:110-117.
5. Busse P.J., Razvi S., Cunningham-Rundles C. Efficacy of intravenous immunoglobulin in the prevention of pneumonia in patients with common variable immunodeficiency. J Allergy Clin Immunol 2002, 109:1001-1004.
6. Cunningham-Rundles C., Bodian C. Common variable immunodeficiency: clinical and immunological features of 248 patients. Clin Immunol 1999, 92:34-48.
7. Lederman H.M., Winkelstein J.A. X-linked agammaglobulinemia: an analysis of 96 patients. Medicine (Baltimore) 1985, 64:145-156.
8. Roifman C.M., Lederman H.M., Lavi S., Stein LD., Levison H., Gelfand EW, et al. Benefit of intravenous IgG replacement in hypogammaglobulinemic patients with chronic sinopulmonary disease. Am J Med 1985, 79:171-174.
9. Winkelstein J.A., Marino M.C., Ochs H., Fuleihan R., Scholl PR., Geha R., et al. The X-linked hyper-IgM syndrome: clinical and immunologic features of 79 patients. Medicine (Baltimore) 2003, 82:373-384.
10. Intravenous immunoglobulin for the prevention of infection in chronic lymphocytic leukemia. A randomized, controlled clinical trial. Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia. N Engl J Med 1988, 319:902-907.
11. Intravenous immune globulin for the prevention of bacterial infections in children with symptomatic human immunodeficiency virus infection. The National Institute of Child Health and Human Developments Intravenous Immunoglobulin Study Group. N Engl J Med 1991, 325:73-80.
12. Dalakas M.C. The use of intravenous immunoglobulin in the treatment of autoimmune neuromuscular diseases: evidence-based indications and safety profile. Pharmacol Ther 2004, 102:177-193.
13. Imbach P., Barandun S., d'Apuzzo V., Baumgartner C., Hirt A., Morell A., et al. High-dose intravenous gammaglobulin for idiopathic thrombocytopenic purpura in childhood. Lancet 1981, 1:1228-1231.
14. Furusho K., Sato K., Soeda T., Matsumoto H., Okabe T., Hirota T., et al. High-dose intravenous gammaglobulin for Kawasaki disease. Lancet 1983, 2:1359.
15. Hughes R., Bensa S., Willison H., Van den Bergh P., Comi G., Illa I., et al. Randomized controlled trial of intravenous immunoglobulin versus oral prednisolone in chronic inflammatory demyelinating polyradiculoneuropathy. Ann Neurol 2001, 50:195-201.
16. Randomised trial of plasma exchange, intravenous immunoglobulin, and combined treatments in Guillain-Barre syndrome. Plasma Exchange/Sandoglobulin Guillain-Barre Syndrome Trial Group. Lancet 1997, 349:225-230.
17. Cherin P., Herson S., Wechsler B., Piette JC., Bletry O., Coutellier A., et al. Efficacy of intravenous gammaglobulin therapy in chronic refractory polymyositis and dermatomyositis: an open study with 20 adult patients. Am J Med 1991, 91:162-168.
18. Cherin P., Herson S., Wechsler B., Piette JC., Bletry O., Ziza JM., et al. Intravenous immunoglobulin for polymyositis and dermatomyositis. Lancet 1990, 336:116.
19. Greco A., De Virgilio A., Rizzo M.I., Tombolini M., Gallo A., Fusconi M., et al. Kawasaki disease: an evolving paradigm. Autoimmun Rev 2015, 14:703-709.
20. Danieli M.G., Gelardi C., Pedini V., Moretti R., Gabrielli A., Logullo F., et al. Subcutaneous IgG in immune-mediate diseases: proposed mechanisms of action and literature review. Autoimmun Rev 2014, 13:1182-1188.
21. Dalakas M.C. Intravenous immune globulin therapy for neurologic diseases. Ann Intern Med 1997, 126:721-730.
22. Guidelli G.M., Tenti S., Pascarelli N.A., Galeazzi M., Fioravanti A., et al. Granulomatosis with polyangiitis and intravenous immunoglobulins: a case series and review of the literature. Autoimmun Rev 2015, 14:659-664.
23. Katz-Agranov N., Khattri S., Zandman-Goddard G. The role of intravenous immunoglobulins in the treatment of rheumatoid arthritis. Autoimmun Rev 2015, 14:651-658.
24. EMA Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) 2010, EMA, London. (CHMP) EMA-CfMPfHU (Ed.).
25. EMA Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) 2012, EMA, London. Use EMA-CfMPfH (Ed.).
26. afssaps Rapport public d'évaluation: GAMMANORM, 165mg/ml solution pour injection (voie sous-cutanée et intramusculaire) 2005, [Paris]. santé Afdssdpd (Ed.).
27. Chapel H.M., Spickett G.P., Ericson D., Engl W., Eibl MM., Bjorkander J, et al. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol 2000, 20:94-100.
28. Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol 2004, 112:1-7.
29. Misbah S., Sturzenegger M.H., Borte M., Shapiro RS., Wasserman RL., Berger M., et al. Subcutaneous immunoglobulin: opportunities and outlook. Clin Exp Immunol 2009, 158(Suppl. 1):51-59.
30. Duhem C., Dicato M.A., Ries F. Side-effects of intravenous immune globulins. Clin Exp Immunol 1994, 97(Suppl. 1):79-83.
31. Dwyer J.M. Manipulating the immune system with immune globulin. N Engl J Med 1992, 326:107-116.
32. Schiff R.I. Transmission of viral infections through intravenous immune globulin. N Engl J Med 1994, 331:1649-1650.
33. Roifman C.M., Schroeder H., Berger M., Sorensen R., Ballow M., Buckley RH., et al. Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency. A randomized double-blind trial. Int Immunopharmacol 2003, 3:1325-1333.
34. Siegel J. The product: all intravenous immunoglobulins are not equivalent. Pharmacotherapy 2005, 25:78S-84S.
35. Hooper J.A. Intravenous immunoglobulins: evolution of commercial IVIG preparations. Immunol Allergy Clin North Am 2008, 28:765-778. [viii].
36. Cherin P., Cabane J. Relevant criteria for selecting an intravenous immunoglobulin preparation for clinical use. BioDrugs 2010, 24:211-223.
37. Nydegger U.E. Safety and side effects of I.V. immunoglobulin therapy. Clin Exp Rheumatol 1996, 14(Suppl. 15):S53-S57.
38. Orbach H., Katz U., Sherer Y., Shoenfeld Y. Intravenous immunoglobulin: adverse effects and safe administration. Clin Rev Allergy Immunol 2005, 29:173-184.
39. Siegel J. Safety considerations in IGIV utilization. Int Immunopharmacol 2006, 6:523-527.
40. Stiehm E.R. Adverse effects of human immunoglobulin therapy. Transfus Med Rev 2013, 27:171-178.
41. Shekelle P.G., Woolf S.H., Eccles M., Grimshaw J. Developing clinical guidelines. West J Med 1999, 170:348-351.
42. Guyatt G.H., Oxman A.D., Vist G.E., Kunz R., Falck-Ytter Y., Alonso-Coello P., et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008, 336:924-926.
43. Brennan V.M., Salome-Bentley N.J., Chapel H.M. Prospective audit of adverse reactions occurring in 459 primary antibody-deficient patients receiving intravenous immunoglobulin. Clin Exp Immunol 2003, 133:247-251.
44. Dashti-Khavidaki S., Aghamohammadi A., Farshadi F., Movahedi M., Parvaneh N., Pouladi N., et al. Adverse reactions of prophylactic intravenous immunoglobulin; a 13-year experience with 3004 infusions in Iranian patients with primary immunodeficiency diseases. J Investig Allergol Clin Immunol 2009, 19:139-145.
45. IDF Treatment experiences and preferences of patients with primary immune deficiency diseases: First National Survey 2003, 1-30. Immune Deficiency Foundation.
46. Bichuetti-Silva D.C., Furlan F.P., Nobre F.A., Pereira CT., Goncalves TR., Gouveia-Pereira M., et al. Immediate infusion-related adverse reactions to intravenous immunoglobulin in a prospective cohort of 1765 infusions. Int Immunopharmacol 2014, 23:442-446.
47. Spath P.J., Granata G., La Marra F., Kuijpers TW., Quinti I. On the dark side of therapies with immunoglobulin concentrates: the adverse events. Front Immunol 2015, 6:11.
48. Dalakas M.C. Intravenous immunoglobulin in the treatment of autoimmune neuromuscular diseases: present status and practical therapeutic guidelines. Muscle Nerve 1999, 22:1479-1497.
49. Knezevic-Maramica I., Kruskall M.S. Intravenous immune globulins: an update for clinicians. Transfusion 2003, 43:1460-1480.
50. Nydegger U.E., Sturzenegger M. Adverse effects of intravenous immunoglobulin therapy. Drug Saf 1999, 21:171-185.
51. Palabrica F.R., Kwong S.L., Padua F.R. Adverse events of intravenous immunoglobulin infusions: a ten-year retrospective study. Asia Pac Allergy 2013, 3:249-256.
52. Ratko T.A., Burnett D.A., Foulke G.E., Matuszewski KA., Sacher RA. Recommendations for off-label use of intravenously administered immunoglobulin preparations. University Hospital Consortium Expert Panel for off-label use of polyvalent intravenously administered immunoglobulin preparations. JAMA 1995, 273:1865-1870.
53. Wiles C.M., Brown P., Chapel H., Guerrini R., Hughes RA., Martin TD., et al. Intravenous immunoglobulin in neurological disease: a specialist review. J Neurol Neurosurg Psychiatry 2002, 72:440-448.
54. Foundation ID IDF Guide for Nurses. Immunoglobulin therapy for primary immunodeficiency diseases 2012.
55. Iagaru N., Ginteza E., Cochino A.V. Adverse reactions to intravenous immunoglobulin therapy. Maedica 2007, 2:294-299.
56. Reid B., Van Allen D., LaGrange C.A., Boissonneault N. Protocol recommendations for administration of intravenous immunoglobulin in Canada. J Infus Nurs 2006, 29:158-164.
57. Stangel M., Hartung H.P., Marx P., Gold R. Intravenous immunoglobulin treatment of neurological autoimmune diseases. J Neurol Sci 1998, 153:203-214.
58. Ballow M. Safety of IGIV therapy and infusion-related adverse events. Immunol Res 2007, 38:122-132.
59. Katz U., Kishner I., Magalashvili D., Shoenfeld Y., Achiron A. Long term safety of IVIg therapy in multiple sclerosis: 10years experience. Autoimmunity 2006, 39:513-517.
60. Condino-Neto A., Costa-Carvalho B.T., Grumach A.S., King A., Bezrodnik L., Oleastro M., et al. Guidelines for the use of human immunoglobulin therapy in patients with primary immunodeficiencies in Latin America. Allergol Immunopathol 2014, 42:245-260.
61. Brannagan T.H. Intravenous gammaglobulin (IVIg) for treatment of CIDP and related immune-mediated neuropathies. Neurology 2002, 59:S33-40.
62. Brannagan T.H., Nagle K.J., Lange D.J., Rowland L.P. Complications of intravenous immune globulin treatment in neurologic disease. Neurology 1996, 47:674-677.
63. Group APIiIE Consensus recommendations for the use of immunoglobulin replacement therapy in immune deficiency 2009.
64. Statement NC Intravenous immunoglobulin: prevention and treatment of disease 1990, 1-23. National Institutes of Health's Medline Plus.
65. Vo A.A., Cam V., Toyoda M., Puliyanda DP., Lukovsky M., Bunnapradist S., et al. Safety and adverse events profiles of intravenous gammaglobulin products used for immunomodulation: a single-center experience. Clin J Am Soc Nephrol 2006, 1:844-852.
66. Alangari A.A., Abutaleb M.H., Albarraq A.A., Al-Dhowailie A.A. Intravenous immunoglobulin utilization in a tertiary care teaching hospital in Saudi Arabia. Saudi Med J 2008, 29:975-979.
67. Yong P.L., Boyle J., Ballow M., Boyle M., Berger M., Bleesing J., et al. Use of intravenous immunoglobulin and adjunctive therapies in the treatment of primary immunodeficiencies: a working group report of and study by the Primary Immunodeficiency Committee of the American Academy of Allergy Asthma and Immunology. Clin Immunol 2010, 135:255-263.
68. Singh-Grewal D., Kemp A., Wong M. A prospective study of the immediate and delayed adverse events following intravenous immunoglobulin infusions. Arch Dis Child 2006, 91:651-654.
69. Ameratunga R., Sinclair J., Kolbe J. Increased risk of adverse events when changing intravenous immunoglobulin preparations. Clin Exp Immunol 2004, 136:111-113.
70. Souayah N., Hasan A., Khan H.M., Yacoub HA., Jafri M. The safety profile of home infusion of intravenous immunoglobulin in patients with neuroimmunologic disorders. J Clin Neuromuscul Dis 2011, 12(Suppl. 4):S1-10.
71. Roberton D.M., Hosking C.S. Use of methylprednisolone as prophylaxis for immediate adverse infusion reactions in hypogammaglobulinaemic patients receiving intravenous immunoglobulin: a controlled trial. Aust Paediatr J 1988, 24:174-177.
72. Bonilla F.A., Bernstein I.L., Khan D.A., Ballas ZK., J.Chinen, Frank MM., et al. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol 2005, 94:S1-63.
73. Hamrock D.J. Adverse events associated with intravenous immunoglobulin therapy. Int Immunopharmacol 2006, 6:535-542.
74. Miyamoto J., Bockle B.C., Zillikens D., Schmidt E., Schmuth M. Eczematous reaction to intravenous immunoglobulin: an alternative cause of eczema. JAMA Dermatol 2014, 150:1120-1122.
75. Pierce L.R., Jain N. Risks associated with the use of intravenous immunoglobulin. Transfus Med Rev 2003, 17:241-251.
76. Gurcan H.M., Ahmed A.R. Frequency of adverse events associated with intravenous immunoglobulin therapy in patients with pemphigus or pemphigoid. Ann Pharmacother 2007, 41:1604-1610.
77. Burks A.W., Sampson H.A., Buckley R.H. Anaphylactic reactions after gamma globulin administration in patients with hypogammaglobulinemia. Detection of IgE antibodies to IgA. N Engl J Med 1986, 314:560-564.
78. Abolhassani H., Sadaghiani M.S., Aghamohammadi A., et al. Home-based subcutaneous immunoglobulin versus hospital-based intravenous immunoglobulin in treatment of primary antibody deficiencies: systematic review and meta analysis. J Clin Immunol 2012, 32:1180-1192.
79. Gardulf A., Nicolay U., Asensio O., Bernatowska E., Bock A, Carvalho BC., et al. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies-a prospective, multi-national study. J Clin Immunol 2006, 26:177-185.
80. Eijkhout H.W., van den Broek P.J., van der Meer J.W. Substitution therapy in immunodeficient patients with anti-IgA antibodies or severe adverse reactions to previous immunoglobulin therapy. Neth J Med 2003, 61:213-217.
81. Ochs H.D., Gupta S., Kiessling P., Nicolay U., Berger M. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol 2006, 26:265-273.
82. Gardulf A., Nicolay U., Math D., Asensio O., Bernatowska E., Bock A., et al. Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG self-infusions at home. J Allergy Clin Immunol 2004, 114:936-942.
83. Fasth A., Nystrom J. Safety and efficacy of subcutaneous human immunoglobulin in children with primary immunodeficiency. Acta Paediatr 2007, 96:1474-1478.
84. Borte M., Oertelt C., Hogy B. Treatment of patients with primary antibody deficiencies in Germany. Klin Padiatr 2005, 217:276-280.
85. Constantinescu C.S., Chang A.P., McCluskey L.F. Recurrent migraine and intravenous immune globulin therapy. N Engl J Med 1993, 329:583-584.
86. Finkel A.G., Howard J.F., Mann J.D. Successful treatment of headache related to intravenous immunoglobulin with antimigraine medications. Headache 1998, 38:317-321.
87. Hopkins S., Jolles S. Drug-induced aseptic meningitis. Expert Opin Drug Saf 2005, 4:285-297.
88. Scribner C.L., Kapit R.M., Phillips E.T., Rickles N.M. Aseptic meningitis and intravenous immunoglobulin therapy. Ann Intern Med 1994, 121:305-306.
89. Kemmotsu Y., Nakayama T., Matsuura H., Saji T. Clinical characteristics of aseptic meningitis induced by intravenous immunoglobulin in patients with Kawasaki disease. Pediatr Rheumatol 2011, 9:28.
90. Evangelou N., Littlewood T., Anslow P., Chapel H. Transverse sinus thrombosis and IVIg treatment: a case report and discussion of risk-benefit assessment for immunoglobulin treatment. J Clin Pathol 2003, 56:308-309.
91. Sekul E.A., Cupler E.J., Dalakas M.C. Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: frequency and risk factors. Ann Intern Med 1994, 121:259-262.
92. Ellis R.J., Swendson M.R., Bajorek J. Aseptic meningitis as a complication of intravenous immunoglobulin therapy for myasthenia gravis. Muscle Nerve 1994, 17:683-684.
93. Jolles S., Sewell W.A., Leighton C. Drug-induced aseptic meningitis: diagnosis and management. Drug Saf 2000, 22:215-226.
94. Rao S.P., Teitlebaum J., Miller S.T. Intravenous immune globulin and aseptic meningitis. Am J Dis Child 1992, 146:539-540.
95. Veranneman N., Van Raemdonck D., Dupont L., Verleden G. Repeated, severe headache in a lung transplant patient: a case report. Acta Clin Belg 2010, 65:269-270.
96. Itkin Y.M., Trujillo T.C. Intravenous immunoglobulin-associated acute renal failure: case series and literature review. Pharmacotherapy 2005, 25:886-892.
97. Dantal J. Intravenous immunoglobulins: in-depth review of excipients and acute kidney injury risk. Am J Nephrol 2013, 38:275-284.
98. Orbach H., Tishler M., Shoenfeld Y. Intravenous immunoglobulin and the kidney-a two-edged sword. Semin Arthritis Rheum 2004, 34:593-601.
99. Epstein J.S., Zoon K.C. Important drug warning: Immune Globulin Intravenous (human) (IGIV) products. Neonatal Netw 2000, 19:60-62.
100. Pharmacovigilance A-CNd Enqête officielle immunoglobulines humaines: atteintes rénales. Direction de l'Evaluation des Médicaments et des Produits Biologiques - Unité de Pharmacovigilance 2006.
101. Canada CB Public Communication-Health Canada endorsed important safety information on Privigen, immune globulin intravenous (human) 2012, [Canada].
102. Daphnis E., Stylianou K., Alexandrakis M., Xylouri I., Vardaki E., Stratigis S., et al. Acute renal failure, translocational hyponatremia and hyperkalemia following intravenous immunoglobulin therapy. Nephron Clin Pract 2007, 106:c143-148.
103. Levy J.B., Pusey C.D. Nephrotoxicity of intravenous immunoglobulin. QJM 2000, 93:751-755.
104. Khan S., Grimbacher B., Boecking C., Chee R., Allgar V., Holding S., et al. Serum trough IgG level and annual intravenous immunoglobulin dose are not related to body size in patients on regular replacement therapy. Drug Metab Lett 2011, 5:132-136.
105. Grenouillet-Delacre M., Delleci C., Rouanes N., Petit G., Etienne G., Pedebosq S., et al. Tolérance des immunoglobulines polyvalentes, impact de l'uitlisation d'un protocole de prescription sur la survenue d'effets indésirables liés au traitement. Rev Med Interne 2006, 27:S326.
106. Grenouillet-Delacre M., Longy-Boursier M. Effets indésirables liés aux immunoglobulines humaines polyvalentes normales: intérêt des mesures de prévention. Rev Med Interne 2008, 29:24-28.
107. Chapman S.A., Gilkerson K.L., Davin T.D., Pritzker M.R. Acute renal failure and intravenous immune globulin: occurs with sucrose-stabilized, but not with D-sorbitol-stabilized, formulation. Ann Pharmacother 2004, 38:2059-2067.
108. Fakhouri F., Fakhouri F. Intravenous immunoglobulins and acute renal failure: mechanism and prevention. Rev Med Interne 2007, 28(1):4-6.
109. Barton J.C., Herrera G.A., Galla J.H., Bertoli LF, Work J., Koopman WJ., et al. Acute cryoglobulinemic renal failure after intravenous infusion of gamma globulin. Am J Med 1987, 82:624-629.
110. Caress J.B., Hobson-Webb L., Passmore L.V., Finkbiner AP., Cartwright MS. Case-control study of thromboembolic events associated with IV immunoglobulin. J Neurol 2009, 256:339-342.
111. Daniel G.W., Menis M., Sridhar G., Scott D., Wallace AE., Ovanesov MV., et al. Immune globulins and thrombotic adverse events as recorded in a large administrative database in 2008 through 2010. Transfusion 2012, 52:2113-2121.
112. Funk M.B., Gross N., Gross S., Hunfeld A., Lohmann A., Guenay S., et al. Thromboembolic events associated with immunoglobulin treatment. Vox Sang 2013, 105:54-64.
113. Marie I., Maurey G., Herve F., Hellot MF, Levesque H. Intravenous immunoglobulin-associated arterial and venous thrombosis; report of a series and review of the literature. Br J Dermatol 2006, 155:714-721.
114. Ramirez E., Romero-Garrido J.A., Lopez-Granados E., Borobia AM., Perez T., Medrano N., et al. Symptomatic thromboembolic events in patients treated with intravenous-immunoglobulins: results from a retrospective cohort study. Thromb Res 2014, 133:1045-1051.
115. Okuda D., Flaster M., Frey J., Sivakumar K. Arterial thrombosis induced by IVIg and its treatment with tPA. Neurology 2003, 60:1825-1826.
116. Elkayam O., Paran D., Milo R., Davidovitz Y., Almoznino-Sarafian D., Zeltser D., et al. Acute myocardial infarction associated with high dose intravenous immunoglobulin infusion for autoimmune disorders. A study of four cases. Ann Rheum Dis 2000, 59:77-80.
117. Caress J.B., Cartwright M.S., Donofrio P.D., Peacock J.E. The clinical features of 16 cases of stroke associated with administration of IVIg. Neurology 2003, 60:1822-1824.
118. Hommes O.R., Sorensen P.S., Fazekas F., Enriquez MM., Koelmel HW., Fernandez O., et al. Intravenous immunoglobulin in secondary progressive multiple sclerosis: randomised placebo-controlled trial. Lancet 2004, 364:1149-1156.
119. Marie I., Herve F., Kerleau J.M., Maurey G., Levesque H. Intravenous immunoglobulin-associated vena cava thrombosis. Thromb Haemost 2006, 96:849-851.
120. Rajabally Y.A., Kearney D.A. Thromboembolic complications of intravenous immunoglobulin therapy in patients with neuropathy: a two-year study. J Neurol Sci 2011, 308:124-127.
121. Gurcan H.M., Keskin D.B., Ahmed A.R. Information for healthcare providers on general features of IGIV with emphasis on differences between commercially available products. Autoimmun Rev 2010, 9:553-559.
122. Condino-Neto A., Costa-Carvalho B.T., Grumach A.S., King A., Bezrodnik L., Oleastro M., et al. Guidelines for the use of human immunoglobulin therapy in patients with primary immunodeficiencies in Latin America. Allergol Immunopathol (Madr) 2014, 42:245-260.
123. Dalakas M.C., Clark W.M. Strokes, thromboembolic events, and IVIg: rare incidents blemish an excellent safety record. Neurology 2003, 60:1736-1737.
124. Paran D., Herishanu Y., Elkayam O., Shopin L., Ben-Ami R. Venous and arterial thrombosis following administration of intravenous immunoglobulins. Blood Coagul Fibrinolysis 2005, 16:313-318.
125. Sorensen R. Expert opinion regarding clinical and other outcome considerations in the formulary review of immune globulin. J Manag Care Pharm 2007, 13:278-283.
126. Bentley P., Rosso M., Sadnicka A., Israeli-Korn S., Laffan M., Sharma P., et al. Intravenous immunoglobulin increases plasma viscosity without parallel rise in blood pressure. J Clin Pharm Ther 2012, 37:286-290.
127. Dalakas M.C. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994, 44:223-226.
128. Reinhart W.H., Berchtold P.E. Effect of high-dose intravenous immunoglobulin therapy on blood rheology. Lancet 1992, 339:662-664.
129. Steinberger B.A., Ford S.M., Coleman T.A. Intravenous immunoglobulin therapy results in post-infusional hyperproteinemia, increased serum viscosity, and pseudohyponatremia. Am J Hematol 2003, 73:97-100.
130. Dhainaut F., Guillaumat P.O., Dib H., Perret G., Sauger A., de Coupade C., et al. In vitro and in vivo properties differ among liquid intravenous immunoglobulin preparations. Vox Sang 2013, 104:115-126.
131. Etscheid M., Breitner-Ruddock S., Gross S., Hunfeld A., Seitz R., Dodt J., et al. Identification of kallikrein and FXIa as impurities in therapeutic immunoglobulins: implications for the safety and control of intravenous blood products. Vox Sang 2012, 102:40-46.
132. Krause I., Blank M., Shoenfeld Y. Anti-DNA and antiphospholipid antibodies in IVIG preparations: in vivo study in naive mice. J Clin Immunol 1998, 18:52-60.
133. Wolberg A.S., Kon R.H., Monroe D.M., Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000, 65:30-34.
134. Woodruff R.K., Grigg A.P., Firkin F.C., Smith I.L. Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients. Lancet 1986, 2:217-218.
135. Germishuizen W.A., Gyure D.C., Stubbings D., Burnouf T. Quantifying the thrombogenic potential of human plasma-derived immunoglobulin products. Biologicals 2014, 42:260-270.
136. Komenda M., Stadler D., Malinas T., Moses M., Pragst I., Herzog E., et al. Assessment of the ability of the Privigen(R) purification process to deplete thrombogenic factor XIa from plasma. Vox Sang 2014, 107:26-36.
137. Crouch E.D., Watson L.E. Intravenous immunoglobulin-related acute coronary syndrome and coronary angiography in idiopathic thrombocytopenic purpura-a case report and literature review. Angiology 2002, 53:113-117.
138. Durand J.M., Lefevre P., Kaplanski G., Retornaz F., Cretel E., Soubeyrand J., et al. Deleterious effects of intravenous immunoglobulin in a patient with thrombotic thrombocytopenic purpura. Am J Hematol 1993, 44:214-215.
139. Grillo J.A., Gorson K.C., Ropper A.H., Lewis J., Weinstein R. Rapid infusion of intravenous immune globulin in patients with neuromuscular disorders. Neurology 2001, 57:1699-1701.
140. Aukrust P., Froland S.S., Liabakk N.B., Muller F., Nordoy I., Haug C., et al. Release of cytokines, soluble cytokine receptors, and interleukin-1 receptor antagonist after intravenous immunoglobulin administration in vivo. Blood 1994, 84:2136-2143.
141. Bagdasarian A., Tonetta S., Harel W., Mamidi R., Uemura Y. IVIG adverse reactions: potential role of cytokines and vasoactive substances. Vox Sang 1998, 74:74-82.
142. Mollnes T.E., Hogasen K., De Carolis C., Vaquero E., Nielsen EW, Fontana L., et al. High-dose intravenous immunoglobulin treatment activates complement in vivo. Scand J Immunol 1998, 48:312-317.
143. Sherer Y., Levy Y., Langevitz P., Rauova L., Fabrizzi F., Shoenfeld Y., et al. Adverse effects of intravenous immunoglobulin therapy in 56 patients with autoimmune diseases. Pharmacology 2001, 62:133-137.
144. Spycher M., Matozan K., Minnig K., Zehnder R., Miescher S., Hoefferer L., et al. In vitro comparison of the complement-scavenging capacity of different intravenous immunoglobulin preparations. Vox Sang 2009, 97:348-354.
145. Wegmuller E. Effect of intravenous immunoglobulin therapy on plasma complement. Transfus Sci 1998, 19:307-318.
146. Sztajzel R., Le Floch-Rohr J., Eggimann P. High-dose intravenous immunoglobulin treatment and cerebral vasospasm: A possible mechanism of ischemic encephalopathy?. Eur Neurol 1999, 41:153-158.
147. Voltz R., Rosen F.V., Yousry T., Beck J., Hohlfeld R. Reversible encephalopathy with cerebral vasospasm in a Guillain-Barre syndrome patient treated with intravenous immunoglobulin. Neurology 1996, 46:250-251.
148. Mignogna M.D., Fortuna G., Leuci S., Ruoppo E., Adamo D., Fedele S., et al. Analysis of thromboembolic risk related to high-dose intravenous immunoglobulin treatment: a preliminary clinical study of 10 patients with autoimmune mucocutaneous blistering diseases. Clin Exp Dermatol 2009, 34:145-150.
149. Huang L., Kanellis J., Mulley W. Slow and steady. Reducing thrombotic events in renal transplant recipients treated with IVIg for antibody-mediated rejection. Nephrology (Carlton) 2011, 16:239-242.
150. Chapman S.N., Mehndiratta P., Johansen M.C., McMurry TL., Johnston KC, Southerland AM, et al. Current perspectives on the use of intravenous recombinant tissue plasminogen activator (tPA) for treatment of acute ischemic stroke. Vasc Health Risk Manag 2014, 10:75-87.
151. Daw Z., Padmore R., Neurath D., Cober N., Tokessy M., Desjardins D., et al. Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: a case series analysis. Transfusion 2008, 48:1598-1601.
152. Berard R., Whittemore B., Scuccimarri R. Hemolytic anemia following intravenous immunoglobulin therapy in patients treated for Kawasaki disease: a report of 4 cases. Pediatr Rheumatol 2012, 10:10.
153. Kahwaji J., Barker E., Pepkowitz S., Klapper E., Villicana R., Peng A., et al. Acute hemolysis after high-dose intravenous immunoglobulin therapy in highly HLA sensitized patients. Clin J Am Soc Nephrol 2009, 4:1993-1997.
154. Miyamae T., Kurosawa R., Mori M., Aihara Y., Aihara M., Yokota S., et al. An infant with gamma-globulin-induced hypersensitivity syndrome who developed Evans' syndrome after a second gamma-globulin treatment. Mod Rheumatol 2004, 14:314-319.
155. Nakagawa M., Watanabe N., Okuno M., Kondo M., Okagawa H., Taga T., et al. Severe hemolytic anemia following high-dose intravenous immunoglobulin administration in a patient with Kawasaki disease. Am J Hematol 2000, 63:160-161.
156. Buchs J.P., Nydegger U.E. Defining the specificity of anti-A/B IgM/G antibodies with different antigens and lectins. Vox Sang 1991, 60:174-180.
157. Okubo S., Ishida T., Yasunaga K. Hemolysis after intravenous immune globulin therapy: relation to IgG subclasses of red cell antibody. Transfusion 1990, 30:436-438.
158. Wilson J.R., Bhoopalam H., Fisher M. Hemolytic anemia associated with intravenous immunoglobulin. Muscle Nerve 1997, 20:1142-1145.
159. Berkovitch M., Dolinski G., Tauber T., Aladjem M., Kaplinsky C. Neutropenia as a complication of intravenous immunoglobulin (IVIG) therapy in children with immune thrombocytopenic purpura: common and non-alarming. Int J Immunopharmacol 1999, 21:411-415.
160. Niebanck A.E., Kwiatkowski J.L., Raffini L.J. Neutropenia following IVIG therapy in pediatric patients with immune-mediated thrombocytopenia. J Pediatr Hematol Oncol 2005, 27:145-147.
161. Tam D.A., Morton L.D., Stroncek D.F., Leshner R.T. Neutropenia in a patient receiving intravenous immune globulin. J Neuroimmunol 1996, 64:175-178.
162. von Gunten S., Schaub A., Vogel M., Stadler BM., Miescher S., Simon HU., et al. Immunologic and functional evidence for anti-Siglec-9 autoantibodies in intravenous immunoglobulin preparations. Blood 2006, 108:4255-4259.
163. Matsuda M., Hosoda W., Sekijima Y., Hoshi K., Hashimoto T., Itoh S., et al. Neutropenia as a complication of high-dose intravenous immunoglobulin therapy in adult patients with neuroimmunologic disorders. Clin Neuropharmacol 2003, 26:306-311.
164. Moalic V., Vaillant C., Ferec C. Transfusion related acute lung injury (TRALI): an unrecognised pathology. Pathol Biol (Paris) 2005, 53:111-115.
165. Berger-Achituv S., Ellis M.H., Curtis B.R., Wolach B. Transfusion-related acute lung injury following intravenous anti-D administration in an adolescent. Am J Hematol 2008, 83:676-678.
166. Cailleux N., Levesque H., Bastit D., Cuvelier A, Muir JF., Courtois H., et al. A rare cause of intra-alveolar hemorrhage: a transfusion-related incident with leukoagglutination due to antigranulocyte antibodies (Trali syndrome). Rev Med Interne 1998, 19:434-437.
167. Rizk A., Gorson K.C., Kenney L., Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001, 41:264-268.
168. Mignogna M.D., Fortuna G., Ruoppo E., Adamo D., Leuci S., Fedele S., et al. Variations in serum hemoglobin, albumin, and electrolytes in patients receiving intravenous immunoglobulin therapy: a real clinical threat?. Am J Clin Dermatol 2007, 8:291-299.
169. Ng S.K. Intravenous immunoglobulin infusion causing pseudohyponatremia. Lupus 1999, 8:488-490.
170. Nguyen M.K., Rastogi A., Kurtz I. True hyponatremia secondary to intravenous immunoglobulin. Clin Exp Nephrol 2006, 10:124-126.
171. Razvi S., Schneider L., Jonas M.M., Cunningham-Rundles C. Outcome of intravenous immunoglobulin-transmitted hepatitis C virus infection in primary immunodeficiency. Clin Immunol 2001, 101:284-288.
172. Cherin P., De Gennes C., Bletry O., Lamas A., Launay M., Dubs A., et al. Ischemic Vernet's syndrome in giant cell arteritis: first two cases. Am J Med 1992, 93:349-352.