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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 immunology2026-07-17

Clinical outcomes and safety of efgartigimod in Guillain-Barré syndrome: a retrospective observation study.

Tao Yongli Y, Yang Ting T, Jiang Chenyang C, Wang Xue X et al.

Guillain-Barré syndrome (GBS) is a severe acute autoimmune neuropathy with limited established therapeutic options. Efgartigimod, a human IgG antibody Fc fragment, can increase IgG degradation, which thus may be a promising therapeutic medicine for GBS. The aims of this study were to evaluate the clinical effectiveness and safety of efgartigimod in GBS patients. A retrospective study was conducted on GBS patients at the first affiliated hospital of Zhengzhou university and Nanyang central hospital from February 2024 to June 2025. The medical records of patients received IVIg, efgartigimod, or IVIg sequential efgartigimod (ISE) were reviewed. Disease severity was evaluated using GBS disability score (GBS-DS) and Inflammatory Neuropathy Cause and Treatment (INCAT) disability score at baseline, week1, week2, week3, week4, and the final follow-up. The primary outcome was the proportion of good improvement, defined as a reduction of at least 2 points in the GBS-DS score compared to the baseline. All adverse events occurred during the treatment period were documented. 52 patients were enrolled and received IVIg (n=20), efgartigimod (n=16), or ISE (n=16). Good improvement was higher in the efgartigimod group than IVIg group both at week 2 (37.5% vs. 0%, p<0.01) and the final visit (81.3% vs. 40.0%, p=0.02). Throughout follow-up, the proportion with GBS-DS ≤1 in the efgartigimod group was consistently higher compared to the other two groups. Although not statistically significant, the mean time to reach GBS-DS ≤1 was shorter in the efgartigimod group (2.6± 1.2 weeks) compared to the IVIg (3.1 ± 1.1 weeks), In the ISE group, the average time to achieve GBS-DS ≤ 1 was 2.8 ± 1.2 weeks. Regarding safety, the incidence of treatment-related adverse events (TEAEs) was lower in the efgartigimod group18.8% (3/16) than in the IVIg50.0% (10/20) and ISE 43.8% (7/16) groups. Based on the preliminary finding, the retrospective real-world data suggesting a potential signal of benefit for efgartigimod in GBS, with no new safety concerns identified. However, this study cannot establish comparative efficacy given the methodological limitations, and large-scale well-controlled head-to-head trials remain imperative.

PMID 42465769
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PubMedCureus2026-07-17

Diagnostic and Therapeutic Challenges in Herpes Simplex Virus-Triggered Anti-N-Methyl-D-Aspartate Receptor Encephalitis Presenting as Acute Psychiatric Illness in a Young Woman: A Case Report.

Rathi Pratik P, Shaikh Fahad Idrees FI, Manohar Tanuja T, Agrawal Arvind A et al.

Anti-N-methyl-D-aspartate receptor (anti-NMDAR) encephalitis is a severe form of autoimmune encephalitis. Symptoms include psychiatric manifestations, seizures, dyskinesias, autonomic instability, and altered consciousness. Recently, Herpes simplex virus (HSV) encephalitis has been recognised as a major cause of secondary autoimmune encephalitis. We report the case of a 23-year-old woman who developed behavioural changes and altered sensorium. She was initially suspected of having a primary psychiatric disorder. Subsequent tests showed the presence of anti-NMDAR antibodies in the cerebrospinal fluid (CSF), and positivity for HSV-1 was confirmed by real-time polymerase chain reaction (PCR). Despite receiving high-dose corticosteroids, IVIG, plasmapheresis, rituximab, acyclovir, and antiviral therapy, the patient was admitted to the ICU, where she stayed for a prolonged period due to respiratory failure, septic shock, and acute kidney injury. This case highlights the diagnostic challenge between viral and autoimmune encephalitis and underlines that patients with acute neuropsychiatric symptoms require early recognition, repeated CSF testing, and multidisciplinary management.

PMID 42465184
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PubMedEuropean journal of pediatrics2026-07-16

Efficacy and safety of different doses of intravenous immunoglobulin combined with phototherapy in neonatal hemolytic disease: a systematic review and meta-analysis.

Huang Meixiang M, Yuan Xixi X, He Jiajia J, Qin Bijing B et al.

Neonatal hemolytic disease is a major cause of neonatal hyperbilirubinemia and kernicterus. Intravenous immunoglobulin (IVIG) combined with phototherapy is a commonly used clinical intervention; however, the optimal dosing regimen remains controversial. This study aimed to systematically evaluate the efficacy and safety of different doses of IVIG combined with phototherapy in the treatment of neonatal hemolytic disease, and to provide evidence-based guidance for optimizing clinical dosing strategies. A comprehensive literature search was conducted in PubMed, Embase, the Cochrane Library, Web of Science, and Scopus, as well as Chinese databases including CNKI, Wanfang Data, VIP, and the Chinese Biomedical Literature Database, from inception to February 2026. Randomized controlled trials comparing high-dose versus low-dose IVIG combined with phototherapy in neonatal hemolytic disease were included. The primary outcomes included exchange transfusion rate, duration of phototherapy, length of hospital stay, serum bilirubin levels at 24 h, hemoglobin levels at 72 h, and incidence of adverse events. Meta-analysis was performed using RevMan 5.4.1, with fixed- or random-effects models applied according to heterogeneity. A total of 10 randomized controlled trials involving 690 neonates were included. Compared with the low-dose IVIG group, the high-dose IVIG group showed a significantly lower exchange transfusion rate (Peto OR = 0.24, 95% CI: 0.12-0.50, P = 0.0001), corresponding to an approximately 76% reduction in the odds of exchange transfusion. High-dose IVIG was also associated with a shorter duration of phototherapy (MD =  - 9.11 h, P = 0.002), a shorter length of hospital stay (MD =  - 1.83 days, P = 0.0008), and lower serum bilirubin levels at 24 h (MD =  - 38.86, P < 0.00001). No statistically significant differences were observed between the two groups in hemoglobin levels at 72 h or adverse reaction rates (all P > 0.05). Compared with low-dose IVIG, high-dose IVIG combined with phototherapy was associated with lower exchange transfusion rates, shorter phototherapy duration and hospital stay, and lower serum bilirubin levels in neonates with hemolytic disease. No statistically significant differences were observed in hemoglobin levels at 72 h or adverse reaction rates between the two groups. Further large-scale, high-quality randomized controlled trials are warranted to confirm these findings and to clarify the potential impact of blood group subtype on treatment response. •Neonatal hemolytic disease remains a common cause of severe neonatal hyperbilirubinemia. •Intravenous immunoglobulin (IVIG) is frequently used as an adjunctive treatment, but the optimal dosage remains uncertain. • This meta-analysis compared different IVIG dosing regimens using randomized controlled trials only. • High-dose IVIG was associated with lower exchange transfusion rates and improved several short-term clinical outcomes.

PMID 42458120
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PubMedThe Indian journal of tuberculosis2026-07-16

Tuberculosis associated hemophagocytic lymphohistiocytosis (TB-HLH)-A case series and role of steroid pulse therapy & intravenous immunoglobulin (IVIG) in a critically ill TB-HLH patient.

Pal Ramesh S RS, Rana Rishi R, Kumar Upendra U, Soni Vinay V et al.

HLH is a life-threatening hyper-inflammatory condition of uncontrolled, ineffective activation of immune cells leading to hemophagocytosis, and damage to multiple organs. Viral, bacterial, tubercular, fungal, parasitic infections, including malignancy and immune disorders are responsible for secondary HLH. In this case series all four cases presented in life threatening condition. All were diagnosed and treated timely with favourable outcome in three cases. ATT is the mainstay of treatment. Corticosteroids are typically the first-line immunosuppressive agents used in TB-HLH. When a low dose steroid appear inadequate, escalation to a higher dose may result in a favourable clinical response. Intravenous immunoglobulin (IVIG), has shown positive outcome in a critically ill patient of our case series. IVIG has immunomodulatory effects and acts on multiple sites, including phagocytosis of mycobacteria. Awareness of tuberculosis associated HLH (TB-HLH) among physicians is needed in regions with a high burden of tuberculosis. TB-HLH can rapidly progress to life-threatening condition and needs early suspicion. Empirical ATT along with steroid may start when there is strong clinical and radiological suspicion, even if initial microbiological results are negative and complete diagnostic criteria of HLH not fulfilled. Keywords Tuberculosis, Hemophagocytic, lymphohistiocytosis, Corticosteroid, Intravenous immunoglobulin.

PMID 42457304
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PubMedFrontiers in immunology2026-07-16

Life-threatening multiorgan immune-related toxicities complicated by sepsis after anti-PD-1 therapy with complete tumor regression: a case report and literature review.

Dong Jun J, Zhang Lijun L, Yu Lei L, Wang Jun J et al.

Immune checkpoint inhibitors (ICIs) enhance antitumor immunity but can disrupt immune tolerance, leading to immune-related adverse events (irAEs) affecting multiple organs. Simultaneous life-threatening multiorgan irAEs remain rare and poorly characterized, particularly in head and neck cancer. A 73-year-old man with sinonasal squamous cell carcinoma developed fulminant multisystem immune toxicity after a single dose of pembrolizumab combined with nab-paclitaxel. The clinical course was marked by Stevens-Johnson syndrome, hematologic and renal failure, pneumonitis, metabolic dysregulation, and recurrent sepsis requiring intensive care. A multidisciplinary strategy, including team discussion, intensive care, corticosteroids and two courses of intravenous immunoglobulin (IVIG), was employed. Dose-escalated corticosteroids may cause potent immunosuppression and potentially raise the risk of opportunistic infections. IVIG serves as an immunomodulator which can balance immune control with infection risk. His organ function recovered despite concurrent catheter-related systemic infection. Remarkably, the patient achieved complete tumor regression after one treatment cycle and disease-free duration was 6 months. This case illustrates the extreme spectrum of immunologic dysregulation associated with PD-1 blockade and highlights the importance of rapid and early diagnosis, multidisciplinary management, and risk-adapted immunomodulation. IVIG may represent a pragmatic therapeutic strategy when escalation of immunosuppression is limited by infection risk. Further investigation is needed to optimize prediction and management of life-threatening multiorgan irAEs.

PMID 42459692
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PubMedParkinsonism & related disorders2026-07-16

Divergent presentations of anti-GAD autoimmunity: a comparative analysis of two neurodegenerative cases.

Zanovello Matteo M, Pavan Sofia S, Petrosino Angela A, Tuppo Rotunno Vittorio V et al.

We describe two women presenting with cortico-basal syndrome (CBS) and upper motor neuron-motor neuron disease (UMN-MND), respectively, both with high-titre GAD-Abs in serum and CSF. Both patients showed progressive motor impairment with elevated NFL levels. IVIg therapy was administered without meaningful clinical benefit, suggesting neurodegeneration as the primary phenotypic driver.

PMID 42456346
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