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Immune Globulin Dosing: An Overview Determining the proper dosage of immune globulin (IG) varies from patient to patient, across diagnoses and many other influencing factors. IG is not a one-size-fits-all drug. The clinical assessment is the most important step in determining dosage but other nonclinical factors also play a role. Understanding the intersection of all of these pieces will ensure patients are given the most therapeutic amount of drug possible. When prescribing IG, the first clinical consideration is the patient’s disease. Initially prescribed to treat primary immune deficiency diseases (PIDD) and immune thrombocytopenic purpura (ITP), time has shown IG to also be effective in treating numerous inflammatory and immune-mediated diseases affecting the neuromuscular system. Currently, the FDA approves IG for a few diagnoses and each IG product’s dosing recommendations are included in its package insert (PI). In addition, physicians also can prescribe IG for off-label indications, but by law, these dosing guidelines cannot be included on the PI. Instead, physicians must use peer-reviewed literature, clinical observations and their best judgement when deciding on the proper dose. An interesting note, once a drug is FDA-approved, physicians can legally prescribe medications for any other purpose. And insurance companies often will cover certain off-label indications as long as it is the standard of care for that particular disease. Establishing the correct dose of IG, which is typically given intravenously (IVIG), is driven by the diagnosis of the patient, the weight of the patient and also the individual response to therapy. Since clinical effects of IG dosing can have significant consequences, clinical trials and scientific studies are employed to help establish maximum and minimum IG dosing standards. Although it is not well-known how much IG is too much there seems to be no medical benefit above a certain level. Using more IG than is medically necessary simply increases costs for all including risk of side effects, fluid volume overload and the need for an already limited natural resource needed to make IG. Too little IG results in ineffective treatment and a poor clinical response and may be more common than realized. This predicament may cause both patient and physician to think the treatment is not working and cause a myriad of negative symptoms causing more testing and treatments, potential disability and decreased productivity and decreased quality of life. There are many factors that can lead to undertreating patients such as: insurance policies attempting to standardize treatments; prescribers not staying current on latest research; limited research funding; product shortages causing rationing of supplies; patient tolerance of treatment; patient compliance. In some cases, insurance policies will carry a reauthorization clause that requires patients, once stabilized on IG, to try a lower dose to see if maintenance can be attained at a lower cost. Another factor that can affect dosing of IG are vial sizes of each product. Each manufacturer has a limited number of vial size options for each product. Doses are determined partly by the patient’s weight and if that requirement adds up to an odd-sized dose that doesn’t evenly match the vial size, the dose is generally rounded up to the nearest available size. Overall, this expensive, lifesaving treatment is certainly unique and complicated to dose correctly and many variables must be considered when trying to ensure patients get the full benefit. More research is definitely needed but in the meantime, following dosing recommendations and staying educated are the best ways to maximize patient outcomes. For more information on this topic see the February/March 2011 issue of IGLiving Magazine online at http://www.igliving.com under Feature Articles. (596 words)