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HOYEE LEONG, PH.D., is Senior Research Specialist, Drug Information and Technology Assessment Groups, University HealthSystem Consortium (UHC), Oak Brook, IL. JOAN STACHNIK, PHARM.D., is Assistant Professor, University of Illinois Medical Center at Chicago, Chicago, IL. MARY ELLEN BONK, PHARM.D., is Manager, Drug Information Group; and KARL A. MATUSZEWSKI, M.S., PHARM.D., is Senior Director, Clinical Knowledge Service, UHC.

Address correspondence to Dr. Matuszewski at University Health-System Consortium, Suite 700, 2001 Spring Road, Oak Brook, IL 60523 (matuszewski{at}uhc.edu).

Purpose. The unlabeled uses of intravenous immune globulin (IVIG) were reviewed. Summary. A literature review was conducted to identify studies examining the unlabeled uses of IVIG. A review of 138 clinical trial abstracts identified 10 trials examining 2 labeled uses (635 patients) and 128 trials examining 61 different off-label uses (6781 patients). The most common off-label indications included multiple sclerosis, graft-versus-host disease in transplant patients, prevention of antiphospholipid syndrome in miscarriage, Guillain-Barré syndrome, and progression of human immunodeficiency virus after delivery. The studies appeared to support many of the acceptable off-label uses cited by various guideline groups. A total of 276 case reports were identified, with 268 reports representing 156 different off-label uses (362 patients). Seven meta-analyses were identified, evaluating recurrent miscarriage, in vitro fertilization failure, infection in preterm infants, multiple sclerosis, immune thrombocytopenic purpura, and pemphigoid. With the exception of recurrent miscarriage and infection in preterm infants, the off-label use of IVIG for these indications was associated with positive outcomes. An examination of IVIG guidelines by specialty society, payer, and other review organizations revealed that the biomedical evidence supporting off-label uses is being interpreted in different ways. Health care institutions are strongly urged to approve and closely monitor specific uses of IVIG to reserve dwindling supplies for the "best-evidence" uses. Clinicians should be aware of the limits of knowledge in many off-label uses and exercise restraint in prescribing for unproven indications. Conclusion. A literature review identified more than 150 unlabeled uses of IVIG. The evidence for these uses is being interpreted in different ways by various reviewing organizations. Index terms: Drugs; Globulin immune; Serums