A clear look at IVIG purity and its impact on
the risk of thromboembolic adverse events.
FXI, coagulation factor eleven; IVIG, intravenous immunoglobulin.
FXIa has been identified as one of the root causes of IVIG-related TEEs.1
FXIa plays a key role in the activation of the intrinsic coagulation cascade.2
One study showed that while coagulation factors FII, FVII, FIX, and FX are effectively removed through common fractionation processes, FXI remained at a residual ratio of approximately 15%–16%.3
Studies have confirmed that even small quantities of FXIa can result in thrombin generation.2
The Immunoglobulin National Society (IgNS) Immunoglobulin Therapy Standards of Practice states that a risk mitigation strategy for thrombosis is to consider administering Ig products with the lowest FXIa levels.4
Learn more about a manufacturing process designed to remove FXIa.
References: 1. Ovanesov MV, Menis MD, Scott DE, et al. Association of immune globulin intravenous and thromboembolic adverse events. Am J Hematol. 2017;92(4):E44-E45. 2. Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol. 2000;65(1):30-34. 3. Kang GB, Huber A, Lee J, et al. Cation exchange chromatography removes FXIa from a 10% intravenous immunoglobulin preparation. Front Cardiovasc Med. 2023;10:1253177. 4. Immunoglobulin National Society. Immunoglobulin Therapy Standards of Practice. 3.2 ed. Ig Society, Inc.; 2024.