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SACHIN SHAH, PHARM.D., BCOP, is Assistant Professor of Pharmacy Practice, School of Pharmacy, Texas Tech University Health Sciences Center, and Hematology/Oncology Clinical Pharmacist, VA North Texas Health Care System, Dallas, TX (sachin.shah{at}ttuhsc.edu).

Purpose. A number of immunoglobulin intravenous (IGIV) products have been approved by the Food and Drug Administration (FDA) and are available commercially. Factors that need to be taken into consideration when selecting an appropriate IGIV product are discussed. Summary. Pathogen safety is of particular concern in IGIV products. Manufacturers of IGIV products have introduced different steps to ensure pathogen inactivation and clearance. Physical viral inactivation methods include heat and pasteurization. Chemical viral inactivation methods include acidic treatment, solvent/detergent, and caprylate. Viral removal is accomplished via precipitation, chromatography, or nanofiltration. Pathogen inactivation processes may inadvertently affect IGIV product characteristics, including composition, concentration, purity, and yield, which may, in turn, affect tolerability, efficacy, and convenience of usage. Tolerability of IGIV products is dependent on factors such as volume load, osmolarity, IgA content, and stabilizing agent. For example, sucrose, used as a stabilizing agent in some IGIV products, has been associated with an increased risk of IGIV-induced acute renal failure. The qualities of IGIV products that contribute to convenience of usage for patients and healthcare professionals include liquid formulation, longer shelf life, multiple package sizes, and shorter infusion time. Cost effectiveness of therapy is another important consideration in IGIV product selection. Contributing factors to cost effectiveness include acquisition cost, reimbursement, product preparation, storage, shelf life, and adverse event management. Conclusion. The various IGIV products differ in terms of production process, tolerability, and convenience. Pharmacists should be cognizant of these differences when ordering IGIV therapy for their patients. Additionally, overall cost-effectiveness of therapy should be an important consideration. Index terms: Concentration; Contamination; Control, quality; Costs; Drug administration; Drug use; Economics; Formulations; Globulin immune; Injections; Manufacturing; Osmolarity; Packaging; Purity; Reimbursement; Serums; Stability; Stabilizers; Storage; Sucrose; Toxicity; Volume

 

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