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immunoglobulin (Bivigam)

✓ Approved

ADMA Biologics, Inc. · Polyclonal Antibodies · Polyclonal Antibodies

What is immunoglobulin?

immunoglobulin is a polyclonal antibodies developed by ADMA Biologics, Inc.. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesBivigam
CompanyADMA Biologics, Inc.
Drug ClassPolyclonal Antibodies, Antibody
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, ADMA Biologics, Inc.

Therapeutic Indications

immunoglobulin is developed for 5 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
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

Related Research Articles

PubMedFrontiers in cellular neuroscience2026-11-12

Immunoglobulins and Efgartigimod reduce neuronal activity in primary rat cortical neuron cultures.

Marti Bautista Felix F, Nazarzadeh Nilufar N, Genseke Niklas N, Groß Elena E et al.

Immunoglobulin-based therapies are increasingly used to modulate neuroinflammatory diseases, yet it remains unclear whether they directly affect neuronal function. Here, we provide evidence that primary rat cortical neurons express both the inhibitory Fc gamma receptor IIb (FcγRIIb) and the neonatal Fc receptor (FcRn), as assessed by immunocytochemistry and mRNA analysis. FcγRIIb expression was upregulated under proinflammatory conditions, indicating inflammation-dependent regulation. Using microelectrode array recordings, we observed that immunoglobulin treatment reduced neuronal activity under both physiological and inflammatory conditions. Similarly, Efgartigimod, a high-affinity FcRn blocker, was associated with a sustained reduction in neuronal activity, with the observed effects suggesting a trend toward dose dependence under control conditions. Together, these findings provide proof-of-concept evidence that primary cortical neuronal cultures respond to immunoglobulins and Efgartigimod in vitro and highlight neuronal Fc receptor signaling as a promising avenue for future studies.

PMID 43016485
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PubMedRadiology case reports2026-11-12

Primary pulmonary MALT lymphoma with probable isolated light chain deposition disease: Case report and literature review.

Elghoul Rachad R, Weingartz Lucas L, Hayat Fateh F, Evans Juanita J et al.

Primary pulmonary extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) is an uncommon lymphoproliferative disorder with variable imaging manifestations that may overlap with infectious, inflammatory, and neoplastic processes. Light chain deposition disease (LCDD) is a rare monoclonal immunoglobulin deposition disorder that may occur in association with indolent B-cell lymphoproliferative disease, although isolated pulmonary involvement remains uncommon. We present the case of a 39-year-old woman initially found to have numerous bilateral pulmonary, hilar, and mediastinal nodules, many demonstrating eccentric calcifications, which raised concern for metastatic disease in the setting of a prior malignancy. Multiple biopsies were initially inconclusive, and serial imaging over several years demonstrated progressive ground-glass and multiseptated cystic changes; subsequent biopsy of an enlarging left lower-lobe lesion, together with molecular evidence of clonal immunoglobulin light-chain gene rearrangements, established the diagnosis of pulmonary MALT lymphoma. Following systemic therapy, surveillance imaging demonstrated development of new peripheral soft-tissue nodular components along several pre-existing cystic lung lesions, highly suggestive of superimposed kappa light chain deposition disease. This case highlights the uncommon association between pulmonary MALT lymphoma and LCDD and showcases the evolving radiologic appearance of these processes over prolonged follow-up. Recognition of cystic change and calcified or cyst-associated nodules in patients with pulmonary MALT lymphoma may suggest an associated light chain deposition disorder and prompt appropriate radiologic-pathologic correlation.

PMID 43017492
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PubMedFrontiers in immunology2026-11-12

High efficacy and tolerability of daratumumab-based regimens in first-line treatment of patients with immunoglobulin light-chain amyloidosis: a real-world evidence analysis.

Cui Yajuan Y, Luo Yunya Y, Li Ji J, Yuan Lingli L et al.

Daratumumab was the first monoclonal antibody targeting cluster of differentiation 38 (CD38) to demonstrate high response rates in both untreated and pretreated cases of immunoglobulin light-chain (AL) amyloidosis. We conducted a single-center, retrospective real-world case series to evaluate the efficacy and safety of daratumumab as a first-line treatment option. Daratumumab was administered with bortezomib and dexamethasone (D-Vd), bortezomib, cyclophosphamide, and dexamethasone (D-VCd), or low-dose dexamethasone (Dd). Forty-four patients were eligible, including 14 patients with stage IIIb. By the 6-month milestone (N = 36), 21 (59%) patients achieved at least complete response (CR), 10 (28%) patients achieved very good partial response (VGPR), and 5 (14%) patients achieved partial response (PR). The cardiac response rate was 50% at 3 months, 69% at 6 months, and 84% at 12 months. The renal response rate reached 40% by the 6-month mark. Importantly, hematologic, cardiac, and renal response rates were generally comparable between stage IIIb and non-stage IIIb patients. After a median follow-up of 13 (range 2-45) months, 6 (14%) patients died, all with stage IIIb disease. The median overall survival (OS) was not reached, with a 6-month survival rate of 93% and a 1-year survival rate of 84%. Univariate analysis showed that Mayo stage IIIb, difference between involved and uninvolved free light chains (dFLC) ≥ 300 mg/L, and a time to treatment of more than 12 months were associated with poor overall survival. Lymphocytopenia emerged as the most prevalent hematologic adverse effect, with grade 3-4 lymphocytopenia observed in 32% of patients. Among non-hematologic adverse reactions, infection was observed in 39% of patients. Daratumumab demonstrates significant efficacy in treating newly diagnosed AL amyloidosis, with excellent hematologic and organ response rates, a remarkable safety profile, and favorable tolerability among AL amyloidosis patients. However, early cardiac mortality before responses could manifest underscores that advanced cardiac stage remains an adverse prognostic factor for OS.

PMID 43016680
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PubMedJACC. Case reports2026-11-12

Unraveling Severe Myocardial Dysfunction in Streptococcal Toxic Shock Syndrome: Beyond Septic Shock.

Dod Rohan R, Drury Jeffrey Kyle JK, Nguyen Catherine C, Santos Jillianne J et al.

Group A Streptococcus is a clinically important yet underrecognized cause of inflammatory myocardial dysfunction, capable of triggering shock through toxin-mediated injury and inflammation. A 19-year-old woman presented with progressive fatigue, severe hypotension, and a purpuric chest rash. Laboratory investigation showed rising troponin, leukocytosis, and lactic acidosis. Echocardiography and right heart catheterization revealed significant biventricular dysfunction. She developed shock requiring mechanical circulatory support with an Impella CP and extracorporeal membrane oxygenation. Corticosteroids and intravenous immunoglobulin were initiated empirically for presumed inflammatory myocarditis. Chest wall biopsy grew Group A Streptococcus, supporting the diagnosis of streptococcal toxic shock syndrome (STSS). Ultimately, she recovered cardiac function with mechanical circulatory support and targeted antimicrobial therapy. This case highlights severe, reversible myocardial dysfunction because of STSS. STSS can precipitate severe, reversible myocardial dysfunction representing a mixed septic-cardiogenic phenotype that may mimic fulminant myocarditis.

PMID 43018523
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PubMedBrazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas2026-11-12

Role of the complement system in normocomplementemic glomerulopathies.

Eid K Z C KZC, Zen R R, Abreu P F PF, Dias C B CB

Complement pathway activation is part of the innate and adaptive immune responses, playing an important role in the defense against microorganisms that cause infection. That activation occurs when a set of proteins and other molecules interact, triggering reactions that are amplified in order to form the membrane attack complex, which is responsible for attacking pathogens. The complement system plays a complex role in glomerulopathies, contributing to tissue inflammation and glomerular injury. In some glomerular diseases, the participation of complement system pathways is confirmed by decreased serum concentrations of specific complements, mainly C3 and C4. In other glomerular diseases, these serum concentrations remain normal, and there is a debate about the importance of complement activation in tissue for the maintenance and worsening of glomerular injury. Such diseases include immunoglobulin A nephropathy, membranous nephropathy, and antineutrophil cytoplasmic antibody-associated vasculitis. Understanding the role of the complement system in the pathophysiology of glomerulopathies is necessary for the development of novel therapies. Therefore, the objective of this review was to evaluate the role of the complement system in these so-called normocomplementemic glomerulopathies.

PMID 43018013
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PubMedCase reports in pediatrics2026-11-12

Severe Iodine Deficiency-Associated Hypothyroidism in a Toddler With Cow's Milk Allergy: A Case Report.

Laidlaw Judit J, Rubin Lauren L

Iodine is an essential micronutrient required for thyroid hormone synthesis and normal growth and neurodevelopment. Although iodine deficiency is uncommon in high-income countries with iodization programs, children with restrictive diets may remain at risk. We report a 23-month-old male who presented with growth deceleration and was found to have severe hypothyroidism. Initial laboratory evaluation demonstrated low FT4 with markedly elevated thyroid-stimulating hormone (> 200 mIU/L). Endocrine evaluation revealed diffuse thyroid enlargement with hypervascularity on ultrasonography and elevated thyroglobulin levels, with negative thyroid autoantibodies. Urinary iodine-to-creatinine ratio was low, consistent with iodine deficiency. Dietary review revealed multiple immunoglobulin E-mediated food allergies, including cow's milk allergy, and reliance on commercially available allergy-free foods lacking iodized salt. The patient was treated with levothyroxine, resulting in rapid normalization of thyroid function. Follow-up demonstrated improvement in urinary iodine levels and resolution of thyroid enlargement. This case highlights iodine deficiency as a reversible cause of severe hypothyroidism and growth delay in young children with restrictive diets. Clinicians should consider iodine deficiency in toddlers with food allergies and growth abnormalities, even in regions where iodine sufficiency is presumed.

PMID 43017410
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