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IV

IVIG (BT 681 5% / IVIG 5%, Biotest / IVIG 10%, Biotest)

✓ Approved

Grifols, S.A. · Monoclonal Antibodies · Monoclonal Antibodies

What is IVIG?

IVIG is a monoclonal antibodies developed by Grifols, S.A.. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesBT 681 5%, IVIG 5%, Biotest, IVIG 10%, Biotest
CompanyGrifols, S.A.
Drug ClassMonoclonal Antibodies, Polyclonal Antibodies, Antibody
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Grifols, S.A.

Therapeutic Indications

IVIG is developed for 8 unique indications across 5 therapeutic areas.

Therapeutic AreaConditionPhase
Nervous system disordersChronic inflammatory demyelinating polyradiculoneuropathy✓ Approved
Immune system disordersSelective IgG subclass deficiency✓ Approved
Nervous system disordersMultifocal motor neuropathy✓ Approved
Nervous system disordersGuillain-Barre syndrome✓ Approved
Blood and lymphatic system disordersThrombocytopenia✓ Approved

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Related Research Articles

PubMedFrontiers in neurology2026-09-19

Comparing the efficacy of first-line immunotherapies in autoimmune encephalitis: a scoping review.

Pithia Rushil R, Thomas John J, Varkey Thomas C TC

This scoping review aims to explore research comparing the efficacy of steroids, IVIG, and PLEX immunotherapies for autoimmune encephalitis (AE) to determine which treatment(s) lead to better clinical outcomes. Autoimmune encephalitis is a neurological disease treated with several different immunotherapies, including steroids, intravenous immunoglobulin (IVIG), and plasma exchange (PLEX). Steroids are often first-line, but it is unclear whether certain immunotherapies are more clinically efficacious. A comprehensive search of the PubMed, Cochrane, and Google Scholar databases from inception to July 1, 2025, was used to identify papers using the following search terms: "autoimmune encephalitis," "encephalitis," "IVIG or intravenous immunoglobulin," "PLEX or plasma exchange," "corticosteroids," and "monotherapy." We identified 14 publications that fell within our search criteria. 10 of the 14 papers were retrospective studies. The remaining papers included 3 prospective studies and 1 single-arm open label clinical trial. Clinical outcomes were assessed using the modified Rankin scale (mRS). At least 5 papers examined clinical outcomes in children, and all 14 papers assessed clinical outcomes in the adult population. 1 paper did not provide information on participant age ranges. 10 papers included data assessing the efficacy of steroids in AE, with 9 papers providing data that steroids improved clinical outcomes. 7 papers assessed the clinical efficacy of IVIG where 6 papers provided data on mRS improvement in AE. Finally, 3 papers assessed mRS improvement with PLEX, where all 3 papers showed PLEX led to clinical improvement. However, it should be noted that several studies had serious to critical risk of bias and moderate to high methodological concern, impeding the reliability of each study's findings. There is limited data separately evaluating first-line immunotherapies to assess whether steroids, PLEX, or IVIG are clinically superior. Thus, exploring which immunotherapy correlates most strongly with improved clinical outcomes through additional prospective studies and randomized clinical trials would be beneficial. Additionally, further data on which combinations or cycling of therapies (i.e., the "zipper method") are most clinically efficacious, depending on patient presentation, demographics, and pathogenic mechanism would be crucial in developing more comprehensive treatment protocols.

PMID 42761082
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PubMedFrontiers in immunology2026-09-18

Differentiating poor prognosis from treatment-related fluctuations in Guillain-Barré syndrome for repeating immunoglobulin treatment: an illustrative case report.

D'Elia Alessio A, Mascia Luciana L, Giaccari Luca Gregorio LG, Comanducci Angela A et al.

Guillain-Barré syndrome (GBS) is an acute immune-mediated polyradiculoneuropathy that may follow infectious triggers and can progress to severe weakness, cranial nerve involvement, autonomic dysfunction, and respiratory failure. Cytomegalovirus (CMV)-associated GBS is often linked to a more severe clinical course. Although intravenous immunoglobulin (IVIG) and plasma exchange are established first-line treatments, management becomes challenging when patients deteriorate after initial therapy, particularly when distinguishing poor prognosis from treatment-related fluctuation (TRF). We report the case of a 42-year-old woman who developed progressive paresthesias, diffuse pain, gait disturbance, areflexia, facial involvement, dysphagia, dysarthria, autonomic dysfunction, and later respiratory failure. Cerebrospinal fluid analysis showed albuminocytologic dissociation, electrodiagnostic studies supported acute polyradiculoneuropathy, and MRI demonstrated contrast enhancement of the facial nerve roots and cauda equina. Serum testing revealed CMV IgM positivity with detectable CMV DNA, consistent with CMV-associated GBS. The patient received IVIG and ganciclovir. After initial stabilization following the first IVIG course, she experienced sudden respiratory deterioration requiring intubation. Given the temporal pattern of stabilization followed by worsening, the episode was interpreted as TRF occurring in a patient with otherwise poor prognostic features. A second IVIG cycle was administered, followed by gradual respiratory and neurological improvement. This case illustrates the clinical difficulty of deciding whether repeated immunotherapy is justified in severe GBS. Current evidence discourages routine second IVIG courses in patients with poor prognosis who fail to respond; however, this recommendation does not necessarily apply to TRF, where renewed immunotherapy may be considered. In this patient, post-IVIG stabilization followed by acute deterioration supported the interpretation of TRF; persistent CMV viremia was considered a possible marker of ongoing immune stimulation. CMV-associated GBS may follow a severe and fluctuating course. Careful distinction between poor prognosis, nonresponse, and treatment-related fluctuation is essential because it directly influences therapeutic decision-making. Close monitoring, individualized immunotherapy, intensive supportive care, and early rehabilitation remain central to optimizing outcomes in severe GBS.

PMID 42756857
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PubMedFrontiers in oncology2026-09-18

Case Report: Neuroretinitis following combination checkpoint inhibition therapy with nivolumab and ipilimumab for stage IIIC melanoma.

Arefin Nuha S NS, Moon Jared J, Roller Aaron B AB, Aung Moe H MH

Neuroretinitis is a very rare but recognized immune-related adverse event (irAE) of immune checkpoint inhibitor (ICI) therapy. We present a case of likely ICI-associated neuroretinitis following combination nivolumab and ipilimumab treatment for stage IIIC cutaneous melanoma. Our patient is a 48-year-old woman with stage IIIC melanoma who developed acute left eye vision loss approximately three months after initiating nivolumab and ipilimumab, near the end of a corticosteroid taper for a concurrent systemic irAE. Examination showed best-corrected visual acuity of 20/400, severely reduced color vision (2/14 Ishihara plates), and a relative afferent pupillary defect in the left eye. Initial fundus exam of that eye revealed optic disc edema with nasal hemorrhages as well as peripapillary macular edema. There was a central scotoma with nasal steps on the Humphrey visual field (mean deviation -13.24 dB). Fluorescein angiography demonstrated disc leakage with inferior arcuate hypoperfusion. Optical coherence tomography (OCT) showed subsequent intraretinal exudates in the nasal macula bilaterally, worse in the left eye. Infectious workup and neuro-imaging were unremarkable. The patient was treated with intravenous methylprednisolone (IVMP) pulse and intravenous immunoglobulin (IVIG) at initial hospitalization, followed by a slow oral prednisone taper along with monthly IVIG outpatient. Her visual acuity in the left eye improved to 20/20 at 6-month follow-up visit. ICI-associated neuroretinitis is rare but vision-threatening and may emerge or worsen during systemic corticosteroid tapering for concurrent irAEs. Prompt recognition, exclusion of infectious mimics, and multidisciplinary management can yield meaningful visual recovery. Comprehensive neuro-ophthalmic assessment for ICI-associated neuro-ophthalmic complications including evaluation of color vision and pupillary function, documentation of fundus appearance, and additional ancillary testing with visual field and OCT analysis is essential.

PMID 42756432
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PubMedFrontiers in medicine2026-09-18

Fulminant group A streptococcal necrotizing fasciitis presenting as severe calf pain after pharyngitis in an adolescent: a case report.

Roncoroni Lisa L, Kühle Jan J, Kousoulas Lampros L, Müller-Peltzer Katharina K et al.

Invasive Group A Streptococcus (GAS) infection can rapidly progress to life-threatening conditions, including necrotizing fasciitis (NF) and streptococcal toxic shock syndrome (STSS). While typically associated with cutaneous breaches or underlying comorbidities, hematogenous seeding following primary pharyngeal infection is a rare but documented phenomenon. Early diagnosis is often complicated by subtle skin changes and the rarity of the disease. A previously healthy 17-year-old female presented with acute pain of the right calf accompanied by severe tachycardia and rapidly progressive hypotension. Notably, she had experienced acute pharyngitis symptoms approximately two days prior to the onset of her soft tissue pain. Physical examination revealed no typical cutaneous hallmarks of necrotizing fasciitis, such as severe erythema, skin discoloration or crepitus. Complicating the diagnosis, radiological imaging strongly suggested acute cholecystitis as an alternative potential source of her systemic sepsis. Due to the absence of conventional typical signs and the presence of a confounding abdominal focus, establishing a diagnosis of NF proved to be an exceptional clinical challenge; the correct diagnosis was ultimately made possible only thanks to a rapid, multidisciplinary discussion involving emergency medicine, radiology and surgical teams. Emergency surgical exploration of the right lower extremity confirmed widespread necrosis of the superficial fascia and subcutaneous tissue. Cultures from both the deep fascial tissue and blood grew monomicrobial Streptococcus pyogenes. The absence of any local skin trauma supported a diagnosis of hematogenous seeding from the recent pharyngeal infection. The patient was aggressively managed in the intensive care unit with multiple rounds of emergency surgical debridement, targeted intravenous antibiotic therapy (high-dose penicillin and clindamycin), vasoactive support, and adjuvant intravenous immunoglobulin (IVIG) therapy. Following a prolonged hospital course, the patient stabilized, recovered completely, and was successfully discharged. Severe pain disproportionate to skin findings after a recent streptococcal infection should prompt consideration of necrotizing fasciitis, even in otherwise healthy adolescents. Early surgical exploration and source control remain central to management, while adjunctive IVIG may be considered in selected patients with suspected streptococcal toxic shock syndrome.

PMID 42755811
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PubMedNeuropsychiatrie : Klinik, Diagnostik, Therapie und Rehabilitation : Organ der Gesellschaft Osterreichischer Nervenarzte und Psychiater2026-09-18

Bilateral pulmonary embolism in anti-NMDA receptor encephalitis presenting as acute psychosis.

Sorajja Natali N, Alper Adir A, Biavati Luca L, Dhakal Rhea R et al.

Anti-N-methyl-D-aspartate (NMDA) receptor encephalitis is an autoimmune disorder that frequently presents with prominent psychiatric manifestations, often leading to misdiagnosis as a primary psychiatric illness. Early recognition is critical, as timely immunotherapy significantly improves outcomes. A 26-year-old previously healthy man presented with acute psychosis following significant emotional stress and first-time marijuana use 3 days earlier. Initially diagnosed with brief psychotic disorder, he developed catatonia and fever. Cerebral spinal fluid (CSF) and serum anti-NMDA receptor antibodies confirmed the diagnosis. His course was complicated by bilateral pulmonary emboli and drug-induced liver injury. Treatment with intravenous immunoglobulin (IVIG) and high-dose corticosteroids resulted in marked improvement. Malignancy work-up was negative. This case underscores the importance of considering autoimmune encephalitis in young patients presenting with new-onset psychosis, in the apparent absence of malignancy. A high index of suspicion and early CSF evaluation can prevent diagnostic delay and improve patient outcomes.

PMID 42754801
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PubMedTransfusion2026-09-18

Breakthrough Hemolysis in Paroxysmal Nocturnal Hemoglobinuria: Mechanistic Insights and Management Strategies.

Raman Ganesh G, Vivek Meghana M, Hasan Rida R, Keel Siobán S et al.

Paroxysmal nocturnal hemoglobinuria (PNH) is a clonal hematopoietic stem cell disorder caused by somatic mutations in the PIGA gene, resulting in loss of glycosylphosphatidylinositol (GPI)-anchored proteins, including the complement regulatory proteins, CD55 and CD59. Their absence leads to complement-mediated intravascular hemolysis. Patients may present with anemia, hemoglobinuria, renal injury, and potentially life-threatening thromboses. Complement inhibitors have transformed treatment for PNH. Terminal complement inhibitors reduce intravascular hemolysis and transfusion requirements but do not prevent C3-mediated extravascular hemolysis. Proximal complement inhibitors address both intravascular and extravascular hemolysis, but some are associated with a higher risk of breakthrough hemolysis (BTH). This article describes a transfusion-independent PNH patient on pegcetacoplan who developed severe BTH post-HLA desensitization using therapeutic plasma exchange (PLE) prior to hematopoietic cell transplantation. The authors reflect on several potential contributors including iatrogenic removal of pegcetacoplan, TPE, IVIG, and ABO-mismatched platelets, offering guidance on reducing the risk of BTH and potential management strategies. The authors provide a detailed description of the patient case, discussing bio-, pharmacologic-, and transfusion-related factors which may promote BTH in PNH patients. This article provides the authors' assessments highlighting the complexity of BTH in PNH patients receiving complement inhibitors, particularly in the setting of TPE and transfusion. Evaluation should consider potential precipitants of BTH, including iatrogenic drug removal and complement-amplifying conditions such as transfusions. Adjunctive C5 inhibition may be required in acute settings, and further studies are needed to define optimal dosing strategies.

PMID 42755219
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