immunoglobulin (Bivigam)
✓ ApprovedADMA 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 Names | Bivigam |
| Company | ADMA Biologics, Inc. |
| Drug Class | Polyclonal Antibodies, Antibody |
| Route | Injectable (Others), Intravenous (IV) |
| Status | Approved |
Therapeutic Indications
immunoglobulin is developed for 5 unique indications across 2 therapeutic areas.
| Therapeutic Area | Condition | Phase |
|---|---|---|
| Congenital, familial and genetic disorders | Combined immunodeficiency | ✓ Approved |
| Congenital, familial and genetic disorders | Wiskott-Aldrich syndrome | ✓ Approved |
| Immune system disorders | Selective IgG subclass deficiency | ✓ Approved |
| Congenital, familial and genetic disorders | Bruton's agammaglobulinaemia | ✓ Approved |
| Immune system disorders | Immunodeficiency | ✓ Approved |
Related Research Articles
Reappraising the role of procalcitonin in predicting intravenous immunoglobulin resistance in Kawasaki disease.
Kundavaram Rajkumar R, Kumar Amber A
Efficacy of Immunoglobulin Therapy for Secondary Prevention of Congenital Cytomegalovirus Infection: A Systematic Review and Meta-Analysis.
Gutowska Klaudia K, Kucińska-Chahwan Anna A, Bednarek Marta M, Jelitto Anna A et al.
Congenital cytomegalovirus (cCMV) is the leading infectious cause of long-term neuro-sensory impairment. Aim of meta-analysis was to evaluate the efficacy of antenatal immunoglobulin therapy-particularly cytomegalovirus-specific hyperimmune globulin (HIG)-in preventing vertical transmission and congenital cytomegalovirus infection (cCMV) in pregnancies complicated by primary maternal CMV infection. A search of PubMed, Cochrane Library, Embase, Scopus, ScienceDirect, Taylor & Francis Online, Wiley Online Library, ClinicalTrials.gov, and Google Scholar identified randomized controlled trials, prospective or retrospective cohort studies including pregnant women with serologically confirmed primary CMV infection. Eligible interventions included antenatal CMV-specific or nonspecific immunoglobulins (vs placebo, usual care, historical controls, or no treatment), although all included studies evaluated CMV-specific HIG. Controlled studies showed no significant reduction in transmission (RR 0.73, 95% CI .54-1.00; P = .051) with moderate heterogeneity. The pooled transmission rate after HIG was 27.2%, with substantial heterogeneity. Current evidence does not support routine antenatal immunoglobulin to prevent cCMV.
Longitudinal changes in inflammatory markers and body weight in adults with primary immunodeficiency receiving immunoglobulin replacement therapy: A retrospective cohort study.
Akgul Balaban Yasemin Y, Inan Mustafa Ilker MI, Kalkan Fikriye F, Sonmez Ezgi E et al.
Immunoglobulin replacement therapy (IgRT) is the cornerstone of treatment for adults with primary immunodeficiency [primary immunodeficiency diseases (PID)]. Its role in infection prevention is well established. However, its effects on systemic inflammation and metabolic parameters remain incompletely understood. This study evaluated one-year changes in inflammatory indices and body weight in adults with PID receiving intravenous (IVIG) or subcutaneous (SCIG) immunoglobulin therapy. This retrospective study included 32 adults with PID. The cohort consisted predominantly of patients with common variable immunodeficiency, along with selected cases of Good syndrome and CTLA-4 insufficiency. Patients received intravenous immunoglobulin (IVIG) (n = 22) or SCIG (n = 10). Inflammatory markers [neutrophil-to-lymphocyte ratio (NLR), C-reactive protein (CRP), neutrophil count] and body weight were assessed at baseline and after 12 months. Non-parametric tests were used due to sample size. Body weight increased significantly in both the IVIG (P = .01) and SCIG (P = .011) groups. In the IVIG group, CRP (P = .005), absolute neutrophil count (P = .017), and NLR (P = .034) decreased significantly. In the SCIG group, body weight increased significantly. However, changes in inflammatory markers were not significant. Platelet counts decreased (P = .012), while WBC counts increased (P = .016). IgRT was associated with increased body weight in adults with PID. This was consistent across both IVIG and SCIG groups. IVIG was also associated with reductions in inflammatory markers. These findings suggest that IgRT may have effects beyond infection prevention. Body weight may be a useful parameter during follow-up of adult PID patients.
A Rare Case of Plasmablastic Myeloma With Dual Kappa and Lambda mRNA Expression Presenting as a Solitary Hard Palate Tumor.
Tanaka Ken K, Hasegawa Masaki M, Katsumi Akira A
Plasmablastic myeloma is an aggressive variant of plasma cell myeloma that can mimic plasmablastic lymphoma when it presents as a solitary mass. Dual kappa and lambda light-chain expression is exceptionally rare and may be missed if evaluation relies on protein-level detection alone. We report the case of a woman in her 80s who presented with left hard palate swelling and underwent resection of a solitary hard palate and maxillary tumor. Histology showed sheets of large plasmablastic cells positive for CD38, CD138, multiple myeloma oncogene 1, and immunoglobulin G, and negative for B-cell markers and Epstein-Barr virus-encoded RNA. Within weeks, she developed malaise, nausea, and pancytopenia. Laboratory studies revealed elevated lactate dehydrogenase and serum immunoglobulin G of 4,409 mg/dL with immunoparesis. Serum free light chains showed mildly elevated kappa and markedly elevated lambda, with a kappa/lambda ratio of 0.02. Positron emission tomography-computed tomography demonstrated diffuse skeletal and splenic fluorodeoxyglucose uptake without additional extramedullary lesions, confirming the hard palate tumor as the only extramedullary site. Bone marrow examination showed marked hypercellularity with extensive replacement by plasmablastic plasma cells expressing cyclin D1, while Epstein-Barr virus studies and anaplastic lymphoma kinase were negative. Light-chain immunohistochemistry showed absent kappa staining and lambda staining in only a small subset of tumor cells, whereas RNA in situ hybridization demonstrated dual light-chain messenger RNA expression in most tumor cells. Cytogenetic analysis revealed 1q21 amplification, deletion of 17p13, and immunoglobulin heavy chain/MAF rearrangement. Despite high-dose dexamethasone, sequential proteasome inhibitor-, anti-CD38 antibody-, and immunomodulatory drug-based therapies, followed by B-cell maturation antigen × CD3 bispecific antibody treatment, the disease remained refractory and the patient died 45 days after diagnosis. This case highlights that transcript-based light-chain testing can uncover exceptionally rare dual kappa and lambda expressions when protein assays are negative or misleading. In solitary plasmablastic lesions, integrated clinicopathological assessment, including cyclin D1, Epstein-Barr virus studies, and RNA in situ hybridization, is critical for accurate diagnosis and recognition of this highly aggressive subtype.
Brucellosis-associated haemophagocytic lymphohistiocytosis in a child.
Kour Ahmad Zaher AZ, Al Abri Hamda H
Haemophagocytic lymphohistiocytosis (HLH) is a life-threatening hyperinflammatory syndrome that may be triggered by infections, including brucellosis. Brucellosis-associated HLH is uncommon in children and may mimic malignancy or severe viral illness.We report a school-aged boy who presented with prolonged fever, pancytopenia, hepatosplenomegaly, hyperferritinaemia, hypertriglyceridaemia and hypofibrinogenaemia, fulfilling six HLH-2004 diagnostic criteria. Blood cultures confirmed Brucella species infection.Targeted antimicrobial therapy with gentamicin, doxycycline and rifampicin resulted in complete clinical and haematological recovery without corticosteroids, intravenous immunoglobulin or cytotoxic therapy.This case highlights the importance of recognising infection-triggered HLH in endemic regions and demonstrates that early treatment of the underlying infection may reverse the hyperinflammatory state.
+9996 more articles available with a free account
Sign up free to view all articles →