RECOMMENDATIONS FOR OFF-LABEL USE OF INTRAVENOUSLY ADMINISTERED IMMUNOGLOBULIN PREPARATIONS

Objective.- To summarize consensus recommendations for off-label uses of standard intravenous immunoglobulin (IVIG), as developed by a Unive rsity Hospital Consortium (UHC) Expert Panel. These findings are inten ded to help guide clinicians in the appropriate and efficient use of I VIG. Participants.- The UHC-sponsored panel included eight physicians (board certified in critical care, hematology, immunology, neurology, oncology, pediatrics, or rheumatology) and two hospital pharmacists. E vidence.- MEDLINE and EMBASE were searched to identify all English-lan guage review articles (n=201) and original reports (n=1904) on IVIG (h uman use only, excluding editorials, letters, and comments) published between January 1982 and March 1994. Relevant original reports (250) a nd review articles (87) were evaluated by the first author (T.A.R.). E xtracted data included laboratory and clinical findings, objective mea sures, or clinical impressions. The evidence quality was graded by stu dy design according to the US Preventive Services. Task Force. Consens us Process.- Before the panel meeting, a draft literature review and r ecommendations were produced by one of the authors (T.A.R.). The recom mendations herein represent consensus (100% agreement) based on the pu blished evidence.Conclusions.- The UHC Expert Panel made specific reco mmendations for 53 off-label indications and the following general rec ommendations: (1) Usually IVIG is indicated only if standard approache s have failed, become intolerable, or are contraindicated; (2) IVIG pr oducts should be considered therapeutically equivalent and interchange able; (3) interproduct pharmaceutical differences should be considered with the patient's clinical and physiological status when selecting a n IVIG product; and (4) currently, IVIG manufacturers cannot guarantee freedom from viral contamination in the finished product.