ORIGINAL RESEARCH article
Front. Immunol.
Sec. Primary Immunodeficiencies
Real-World Retrospective Cohort Study Evaluating the Tolerability of Immune Globulin Intravenous 10% (BIVIGAM®)
Provisionally accepted
- 1Healix Infusion Therapy, LLC, Sugar Land, United States
- 2Central Georgia Infectious Disease, Macon, GA, United States
- 3Naples Allergy Center, Naples, FL, United States
- 4AIR Care, Dallas, TX, United States
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Introduction: Intravenous immune globulin 10% liquid (IVIG 10%) is used in the treatment of primary immunodeficiency (PID). Originally approved in 2012 and then voluntarily withdrawn in 2016, IVIG 10% (BIVIGAM®) underwent manufacturing process improvements by a new manufacturer and was reintroduced to the US market in 2019. The purpose of this real-world study is to assess the tolerability of BIVIGAM in an outpatient setting. Methods: An observational, retrospective analysis was performed using a random sample of patients who initiated BIVIGAM from 8/2021-5/2022 in 15 US outpatient physician office infusion centers. Patient data collected from electronic medical records included baseline characteristics, BIVIGAM treatment details, adverse events (AEs) and clinical laboratory data for 6 months following initiation. Results: A total of 60 patients treated with BIVIGAM were included. The mean age was 74±8.2 years, 82% were female, and 90% had prior experience with immune globulin therapy. Treatment diagnoses were PID-related in the majority of patients (58,97%).There were 346 BIVIGAM infusions (mean of 5.8±2.6 infusions per patient, mean dose of 492±200.8 mg/kg),titrated upward over a mean of 80±27.9 minutes to a final maximum mean infusion rate of 158±28.8 mL/hr. Pre-medications were used in 83% of patients during 266 infusions. Forty-six AEs were patients (38.3%), resulting in an overall AE rate per infusion of 0.13 per patient year. Discussion: BIVIGAM was well-tolerated within this real-world outpatient setting. Infusion-related adverse reactions were low. This study provides the largest real-world evaluation of reformulated BIVIGAM in outpatient practice.
Keywords: Intravenous immunoglobulin (IVIg), Primary immunodeficiency (PID), BIVIGAM®, tolerability, Real-world evidence (RWE)
Received: 17 Aug 2025; Accepted: 24 Nov 2025.
Copyright: © 2025 Van Anglen, Luu, Rosenbach and Herrscher. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Lucinda J. Van Anglen
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.