{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T06:30:59Z","timestamp":1765866659227,"version":"3.48.0"},"reference-count":15,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T00:00:00Z","timestamp":1765843200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"\n Introduction<\/jats:title>\n \n 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 Originally approved in 2012 and then voluntarily withdrawn in 2016, IVIG 10% (BIVIGAM\n \u00ae<\/jats:sup>\n ) 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.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A total of 60 patients treated with BIVIGAM were included. The mean age was 74 \u00b1 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 \u00b1 2.6 infusions per patient, mean dose of 492 \u00b1 200.8 mg\/kg),titrated upward over a mean of 80 \u00b1 27.9 minutes to a final maximum mean infusion rate of 158 \u00b1 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.<\/jats:p>\n <\/jats:sec>\n \n Discussion<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>","DOI":"10.3389\/fimmu.2025.1687588","type":"journal-article","created":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T06:26:54Z","timestamp":1765866414000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-world retrospective cohort study evaluating the tolerability of immune globulin intravenous 10% (BIVIGAM\u00ae)"],"prefix":"10.3389","volume":"16","author":[{"given":"Lucinda J.","family":"Van Anglen","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Quyen","family":"Luu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin P.","family":"Rosenbach","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard F.","family":"Herrscher","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2025,12,16]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2006.01.015","article-title":"Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology","volume":"117","author":"Orange","year":"2006","journal-title":"J Allergy Clin Immunol"},{"key":"B2","doi-asserted-by":"publisher","first-page":"S1","DOI":"10.1016\/j.jaci.2016.09.023","article-title":"Update on the use of immunoglobulin in human disease: A review of evidence","volume":"139","author":"Perez","year":"2017","journal-title":"J Allergy Clin Immunol"},{"key":"B3","doi-asserted-by":"publisher","first-page":"34","DOI":"10.1006\/clim.1999.4725","article-title":"Common variable immunodeficiency: clinical and 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2024"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1009433","article-title":"Intravenous immune globulin in autoimmune and inflammatory diseases","volume":"367","author":"Gelfand","year":"2012","journal-title":"N Engl J Med"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1586\/ern.09.30","article-title":"Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy: the ICE trial","volume":"9","author":"Hughes","year":"2009","journal-title":"Expert Rev Neurother"},{"key":"B9","volume-title":"BIVIGAM\u00ae (immune globulin intravenous [human]) 10% liquid [prescribing information]","year":"2023"},{"key":"B10","volume-title":"Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)","year":"2021"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1586\/1744666X.2014.891438","article-title":"A new intravenous immunoglobulin (BIVIGAM(R)) for primary humoral immunodeficiency","volume":"10","author":"Wasserman","year":"2014","journal-title":"Expert Rev Clin Immunol"},{"key":"B12","volume-title":"ADMA Biologics Reports Successful Close-Out of its April 2018 FDA Compliance Inspection","year":"2018"},{"key":"B13","volume-title":"ADMA Biologics Submits Response and Provides Supplemental Information to FDA for BIVIGAM\u00ae Complete Response Letter","year":"2019"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.2217\/imt-2019-0157","article-title":"Manufacturing process optimization of ADMA Biologics' intravenous immunoglobulin products, BIVIGAM((R)) and ASCENIV","volume":"11","author":"Wasserman","year":"2019","journal-title":"Immunotherapy"},{"key":"B15","volume-title":"ADMA Biologics Announces Commercial Relaunch and Its First Commercial Sales of BIVIGAM\u00ae","year":"2019"}],"container-title":["Frontiers in Immunology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fimmu.2025.1687588\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T06:26:56Z","timestamp":1765866416000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fimmu.2025.1687588\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,16]]},"references-count":15,"alternative-id":["10.3389\/fimmu.2025.1687588"],"URL":"https:\/\/doi.org\/10.3389\/fimmu.2025.1687588","relation":{},"ISSN":["1664-3224"],"issn-type":[{"value":"1664-3224","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,16]]},"article-number":"1687588"}}