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Recommendations for Off-Label Use of Intravenously Administered Immunoglobulin Preparations

Thomas A. Ratko, PhD; David A. Burnett, MD; Garrett E. Foulke, MD; Karl A. Matuszewski, MS, RPh; Ronald A. Sacher, MD
JAMA. 1995;273(23):1865-1870. doi:10.1001/jama.1995.03520470073035.
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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.(JAMA. 1995;273:1865-1870)


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