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
T. A. Ratko, D. A. Burnett, G. E. Foulke, K. A. Matuszewski and R. A. Sacher
Technology Assessment Program, University Hospital Consortium, Oak Brook, Ill 60521-1890, USA.
OBJECTIVE--To summarize consensus recommendations for off-label uses of
standard intravenous immunoglobulin (IVIG), as developed by a University
Hospital Consortium (UHC) Expert Panel. These findings are intended to help
guide clinicians in the appropriate and efficient use of IVIG.
PARTICIPANTS--The UHC-sponsored panel included eight physicians (board
certified in critical care, hematology, immunology, neurology, oncology,
pediatrics, or rheumatology) and two hospital pharmacists.
EVIDENCE--MEDLINE and EMBASE were searched to identify all English-language
review articles (n = 201) and original reports (n = 1904) on IVIG (human
use only, excluding editorials, letters, and comments) published between
January 1982 and March 1994. Relevant original reports (250) and review
articles (87) were evaluated by the first author (T.A.R.). Extracted data
included laboratory and clinical findings, objective measures, or clinical
impressions. The evidence quality was graded by study design according to
the US Preventive Services Task Force. CONSENSUS PROCESS--Before the panel
meeting, a draft literature review and recommendations were produced by one
of the authors (T.A.R.). The recommendations herein represent consensus
(100% agreement) based on the published evidence. CONCLUSIONS--The UHC
Expert Panel made specific recommendations for 53 off-label indications and
the following general recommendations: (1) Usually IVIG is indicated only
if standard approaches have failed, become intolerable, or are
contraindicated; (2) IVIG products should be considered therapeutically
equivalent and interchangeable; (3) interproduct pharmaceutical differences
should be considered with the patient's clinical and physiological status
when selecting an IVIG product; and (4) currently, IVIG manufacturers
cannot guarantee freedom from viral contamination in the finished product.
Unlabeled uses of intravenous immune globulin
Leong et al.
Am J Health Syst Pharm 2008;65:1815-1824.
ABSTRACT
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Pharmacy considerations for the use of IGIV therapy
Shah
Am J Health Syst Pharm 2005;62:S5-S11.
ABSTRACT
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Use of i.v. immune globulin and occurrence of associated acute renal failure and thrombosis
Shah and Vervan
Am J Health Syst Pharm 2005;62:720-725.
ABSTRACT
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Responding to the Immunoglobulin Shortage: A Case Study
Boulis et al.
Journal of Health Politics, Policy and Law 2002;27:977-1000.
ABSTRACT
Despair of repair
Stangel and Hartung
J. Neurol. Neurosurg. Psychiatry 2002;72:1-4.
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Intravenous Immunoglobulin-Related Acute Coronary Syndrome and Coronary Angiography in Idiopathic Thrombocytopenic Purpura: A Case Report and Literature Review
Crouch and Watson
ANGIOLOGY 2002;53:113-117.
ABSTRACT
Intravenous immunoglobulin application following immunoadsorption: benefit or risk in patients with autoimmune diseases?
Schmaldienst et al.
Rheumatology (Oxford) 2001;40:513-521.
ABSTRACT
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Intravenous Immunoglobulin in Acute Rheumatic Fever : A Randomized Controlled Trial
Voss et al.
Circulation 2001;103:401-406.
ABSTRACT
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Vasoactive side effects of intravenous immunoglobulin preparations in a rat model and their treatment with recombinant platelet-activating factor acetylhydrolase
Bleeker et al.
Blood 2000;95:1856-1861.
ABSTRACT
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Is the Routine Use of Intravenous Immunoglobulin Treatment in Neurologic Disorders Justified?: No
Karussis and Abramsky
Arch Neurol 1999;56:1028-1032.
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Intravenous Immune Globulin Shortage: Experience at a Large Children's Hospital
Gurwitch et al.
Pediatrics 1998;102:645-647.
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