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immunoglobulin (Bivigam)

✓ Approved

ADMA Biologics, Inc. · 多克隆抗体 · 多克隆抗体

什么是 immunoglobulin?

immunoglobulin 是一种多克隆抗体,由ADMA Biologics, Inc.研发。该药已获批,用于治疗相关适应症,给药途径:Injectable (Others)、Intravenous (IV)。

药物档案

商品名Bivigam
公司ADMA Biologics, Inc.
药物类别多克隆抗体, 抗体
给药途径Injectable (Others), Intravenous (IV)
状态Approved

治疗适应症

immunoglobulin 针对 5 个适应症,涉及 2 个治疗领域。

治疗领域疾病/病症分期
Congenital, familial and genetic disordersCombined immunodeficiency✓ Approved
Congenital, familial and genetic disordersWiskott-Aldrich syndrome✓ Approved
Immune system disordersSelective IgG subclass deficiency✓ Approved
Congenital, familial and genetic disordersBruton's agammaglobulinaemia✓ Approved
Immune system disordersImmunodeficiency✓ Approved

相关研究文献

PubMedJournal of cutaneous medicine and surgery2026-07-27

Management of Refractory Eosinophilic Fasciitis Using Biologic Therapies, Janus Kinase Inhibitors, and Intravenous Immunoglobulin: A Systematic Review.

Mitwalli Mohammed M, Waked Jihad Abou Ali JAA, Sood Siddhartha S, Abduelmula Abrahim A et al.

PMID 42504410
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PubMedCureus2026-07-27

De Novo Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits (PGNMID) in a Renal Transplant Recipient.

Murugesan Ram Prabahar RP, Sivanandam Sathiyan S, Jayam Jayanivash J, Kurian Anila A AA

Proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID) represents a distinct glomerular pathology, classified under monoclonal gammopathy of renal significance (MGRS). In renal transplant, PGNMID usually develops as a recurrent disease, but can rarely arise de novo. Recurrence is relatively common, typically appearing within five to six months post-transplant, and is linked to poor graft outcomes. De novo PGNMID is exceedingly rare, with few reported in the literature. It generally presents in the late post-transplant period, with a more indolent clinical course and a variable response to immunotherapy. This case report is of a 50-year-old patient who had diabetic nephropathy as his native kidney disease. This report documents a unique instance of de novo PGNMID, occurring three years post-transplantation with persistent allograft dysfunction. The transplant kidney biopsy showed mesangial hypercellularity with immunoglobulin (Ig)G and kappa light chain deposition by immunofluorescence; however, electron microscopy was non-contributory due to the absence of viable glomeruli. Despite extensive evaluation, we could not identify any clone contributing to the MGRS in the bone marrow, nor could we identify any other evidence of lymphoproliferative disease on positron emission tomography-computed tomography (PET-CT). We managed the patient with empirical clone-directed therapy against a likely B-cell clone using Rituximab. During rituximab therapy, the patient developed E. coli urosepsis, which was managed successfully. At the last follow-up, graft function remained stable without progression, although the duration of follow-up is limited.

PMID 42504369
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PubMedFood science and technology international = Ciencia y tecnologia de los alimentos internacional2026-07-27

Allergenic protein behavior, parvalbumin (PA) contained in skipjack tuna (Katsuwonus pelamis) during the fish sauce processing stage.

Amalia Ulfah U, Romadhon Romadhon R, Purnamayati Lukita L

Parvalbumin (PA) is a major muscle allergen in fish capable of triggering immunoglobulin E-mediated hypersensitivity reactions in fish-allergic individuals. This study investigated the degradation and allergenic behavior of PA in skipjack tuna (Katsuwonus pelamis) sauce during a 60-day fermentation process, sampled at 20-day intervals. Sodium dodecyl sulfate-polyacrylamide gel electrophoresis and immunoblotting were used to monitor PA profiles and immunoglobulin G (IgG)-binding ability, which revealed a thin, undetectable band of PA and low IgG-binding ability by immunoblotting with the progress of fish sauce manufacturing. Additionally, because skipjack tuna belongs to the Scombridae family, histamine levels, pH, total acidity, and total soluble peptides were analyzed to ensure food safety and monitor proteolysis. The results demonstrated that PA bands became progressively thinner and undetectable by day 60, which strongly correlated with a marked decrease in IgG-binding ability. Fermentation also triggered significant peptide solubilization, while histamine content showed a strong correlation with changes in pH and total acidity. These findings demonstrate that traditional fish sauce processing effectively degrades the allergenic protein PA, highlighting fermentation as a viable method to reduce allergenicity in scombroid fish products while maintaining standard quality markers.

PMID 42506887
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PubMedCells2026-07-27

The Basophil Activation Test in Allergy Diagnostics: Clinical Applications, Methodological Challenges, and Proposed Clinical Frameworks.

Izmailovich Marina M, Kabyldina Aizhan A, Seilkhan Zamira Z, Zhussip Aruzhan A et al.

The basophil activation test (BAT) is a modern in vitro functional assay used for the diagnosis of immunoglobulin E-mediated allergic reactions. The method is based on flow cytometric assessment of activation marker expression on peripheral blood basophils after stimulation with specific allergens. BAT has gained increasing clinical relevance in allergology, particularly in patients with anaphylaxis risk, polysensitization, drug hypersensitivity, and inconclusive skin or serological test results. This narrative review summarizes current evidence on the diagnostic performance and clinical applications of BAT in food allergy, drug hypersensitivity, Hymenoptera venom allergy, latex sensitization, and allergen immunotherapy monitoring. The review discusses the immunological mechanisms of basophil activation, the role of CD63 and CD203c, methodological aspects of the assay, sensitivity and specificity data, and advantages and limitations compared with conventional diagnostic approaches. Particular attention is given to protocol standardization, interpretation criteria, and the problem of non-responder patients. Current evidence indicates that BAT demonstrates high specificity and provides functional assessment of clinically relevant allergic reactions. In addition, this review proposes practical clinical frameworks for integrating BAT into allergy diagnostic pathways and for managing inconclusive or non-responder BAT results. Further standardization, multiplex formats, and automated analytical approaches may expand its role in personalized allergy diagnostics.

PMID 42505351
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PubMedLangmuir : the ACS journal of surfaces and colloids2026-07-27

Written in Water: Hydration Repulsion Governs Selective Protein Adsorption on Saccharide Self-Assembled Monolayers.

Zhao Zhentao Z, Hayashi Tomohiro T

Saccharide-based materials are essential in bioinspired design, yet their mechanisms for resisting nonspecific protein adsorption while permitting specific binding remain unclear. This study systematically explores the relationship between surface forces and protein adsorption on glucose (Glc), lactose (Lac), and maltose (Mal) self-assembled monolayers (SAMs). Surface-sensitive techniques revealed protein resistance in the order: Mal > Lac > Glc. Among the tested proteins, bovine serum albumin (BSA) showed the lowest adsorption, immunoglobulin G (IgG) was intermediate, and fibrinogen adsorbed the most, demonstrating saccharide-dependent selectivity. Measurements revealed these surfaces generate short-range repulsive forces in physiological buffer, caused by structured interfacial water layers. The key finding is a strong link between hydration repulsion and protein adsorption behavior. The structural features of saccharides influence their interfacial water organization through hydrogen bonding, which controls resistance to nonspecific adsorption. Overall, the interfacial water acts as a dynamic barrier against protein binding. Analysis of mixed-charge residue pairs (glutamic acid-lysine and aspartic acid-lysine) on proteins, combined with potential saccharide recognition sites, suggests selective adsorption results from interplay between protein surface chemistry and interfacial hydration. This work clarifies hydration repulsion mechanisms on saccharide surfaces, establishes quantitative relationships between structure, hydration, and performance, and provides design principles for advanced biomaterials.

PMID 42503639
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PubMedClinica chimica acta; international journal of clinical chemistry2026-07-27

Diagnostic pitfall: NSAID-induced membranous nephropathy with PLA2R positivity, IgG1-predominant deposits, C1q positivity, and concurrent acute interstitial nephritis-A case report.

Li Jingzhen J, Zhang Qianqian Q, Chen Zhengyue Z, Qiu Yingyin Y et al.

Serum anti-phospholipase A2 receptor (PLA2R) antibody is widely used to diagnose primary membranous nephropathy (MN), but PLA2R positivity also occurs in secondary MN, especially nonsteroidal anti-inflammatory drug (NSAID)-induced MN, leading to a common diagnostic pitfall. We report a 71-year-old female with long-term unsupervised NSAID administration for polymyalgia rheumatica, presenting with recurrent nephrotic syndrome and acute kidney injury. Initial laboratory tests revealed severe hypoalbuminemia (15.7 g/L), elevated serum creatinine (3.98 mg/dL), massive proteinuria (10.24 g/24 h), and positive anti-PLA2R antibody (39.69 U/mL). The etiology of her first nephrotic episode remained unclear, and renal biopsy during disease relapse finally confirmed NSAID-induced secondary MN. Pathological examination demonstrated PLA2R-positive MN with immunoglobulin G1 (IgG1)-predominant immune deposits, moderate (2+) glomerular complement component 1q (C1q) deposition, and concomitant severe acute interstitial nephritis. The patient achieved clinical remission after NSAID discontinuation and treatment with intravenous methylprednisolone combined with rituximab, but disease relapse occurred after inadvertent NSAID re-exposure. This case highlights that PLA2R positivity does not exclude drug-induced secondary MN. IgG subclass profiling and C1q staining are critical complementary biomarkers for precise differential diagnosis and can effectively prevent the common diagnostic pitfall of attributing PLA2R positivity exclusively to primary MN. Permanent NSAID discontinuation remains the cornerstone of disease management.

PMID 42503368
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