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IV

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

✓ Approved

Grifols, S.A. · 单克隆抗体 · 单克隆抗体

什么是 IVIG？

IVIG 是一种单克隆抗体，由Grifols, S.A.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BT 681 5%, IVIG 5%, Biotest, IVIG 10%, Biotest
公司Grifols, S.A.
药物类别单克隆抗体, 多克隆抗体, 抗体
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Grifols, S.A.

治疗适应症

IVIG 针对 8 个适应症，涉及 5 个治疗领域。

治疗领域疾病/病症分期
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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相关研究文献

PubMedZhongguo shi yan xue ye xue za zhi2026-08-03

[Infection Characteristics and Survival Status of Lymphoma Patients after Autologous Hematopoietic Stem Cell Transplantation with the Application of Intravenous Immunoglobulin].

Lyu Bin B, Gu Xue-Jiao XJ, Tian Ming-Xi MX, Huang Zi-Qing ZQ et al.

To explore the infection characteristics and survival status of lymphoma patients who received intravenous immunoglobulin (IVIG) after autologous hematopoietic stem cell transplantation (AHSCT). The clinical data of 121 lymphoma patients who underwent AHSCT from September 2019 to September 2023 were retrospectively analyzed. A Cox proportional hazards model was used to identify risk factors for post-transplant infection-free survival. The patients were divided into IVIG and non-IVIG group according to whether they received IVIG after transplantation, and their infection and survival outcomes were compared. Within 1 year after transplantation, bacterial, viral, and fungal infections occurred in 37 (30.58%), 18 (14.88%), and 3 (2.48%) of the 121 lymphoma patients, respectively. The 1-year overall infection rate after transplantation was 38.1% in the IVIG group (42 patients) and 44.3% in the non-IVIG group (79 patients). In the IVIG group, median infection time was +55 (9-233) days, with 7 cases of early infection, 5 cases of blood stream infection, and 6 cases of respiratory tract infection. In the non-IVIG group, median infection time was +8 (4-122) days, with 27 cases of early infection, 20 cases of bloodstream infection, and 4 cases of respiratory tract infection. IVIG group had fewer early and bloodstream infections, more respiratory tract infections, and a delayed median infection time compared to non-IVIG group. Multivariate Cox regression analysis indicated that pre-transplant serum IgG< 7 g/L, graft MNC< 8.1×108/kg and CD34+ cells≤2.8×106/kg served as independent risk factors for infection-free duration in AHSCT-treated lymphoma patients. The 3-year progression-free survival rates of the IVIG group and non-IVIG group were 52.3% and 48.4%, respectively, and 3-year overall survival rates were 79.4% and 83.0%. At 1 month post-transplant, 69 patients showed a decline in immunoglobulin levels, and 12 patients developed severe hypogamaglobulinemia (HG) (IgG< 4 g/L), with 4 cases (15.4%) in IVIG group and 8 cases (18.6%) in non-IVIG group. One month after transplantation, patients with serum IgG< 4 g/L had a significantly lower survival rate than those with IgG≥4 g/L (55.0% vs. 83.0%). In lymphoma patients, post-AHSCT early stage sees mainly bacterial infections. Some develop severe HG. The utilization of IVIG is capable of reducing the incidence of early post-transplant infections and severe HG.

PMID 42544654
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PubMedClinical and experimental rheumatology2026-08-03

Risk factors and long-term follow-up in acute Kawasaki disease patients with medium or large coronary artery aneurysms.

Li Wei W, Tong Yuantao Y, Xue Xiqiao X, Su Lu L et al.

Kawasaki disease (KD) is a systemic vasculitis that affects children under the age of five. Comprehensive data on KD patients with medium or large CAA are limited. This study aims to investigate the risk factors and long-term follow-up of KD patients with medium or large CAA in a Chinese cohort. We performed a cohort study of 220 KD patients including 55 patients associated with medium or large CAA and 165 patients without coronary artery abnormality between January 2015 and April 2020. Univariate and multivariate logistic regression analyses were used to identify risk factors. All enrolled patients were followed up for more than 12 months. Days to initial IVIG treatment, IVIG resistance, albumin level and platelet count were independent risk factors for KD patients with medium or large CAA based on multivariate logistic regression analysis. At a mean follow-up duration of 49 months, CAA subgroup analysis showed that 19 medium CAA cases (54.3%) promisingly regressed to normal coronary artery diameter, with the constituent ratios of small, medium, and large CAA being 31.4%, 8.6%, and 5.7%, respectively. In contrast, none of large CAA subgroup returned to normal coronary arteries. The constituent ratio of small, medium and large CAA was 15.0%, 25.0% and 60.0%. Besides, we found that coronary thrombosis occurred in 11 acute-phase cases (20.0%; 2 in the medium CAA, 9 in the large CAA), which increased to 18 cases (32.7%; 5 in the medium CAA, 13 in the large CAA) at the end of follow-up. Days to initial IVIG treatment, IVIG resistance, albumin levels and platelet count were risk factors for KD patients with medium or large CAA. The prognosis of medium or large CAA is not ideal during a long-term follow-up, particularly for large CAA.

PMID 42544607
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PubMedJournal of feline medicine and surgery2026-08-03

EXPRESS: Evaluation of the clinical course of immune-mediated polyneuropathy in cats following treatment with human intravenous immunoglobulins.

Schmitz Annika Katharina AK, Sablotni Aguilera Alexander Paul AP, Buhmann Gesine G, van Renen Jana J et al.

Immune-mediated polyneuropathy (IMPN) manifests with generalized lower motor neuron (LMN) weakness and a remittent or relapsing clinical course. Evidence-based treatment recommendations for severely or chronically affected cats are limited. The objective of this study was to evaluate the clinical course and outcome of cats with IMPN following treatment with human intravenous immunoglobulins (hIVIg). Medical records from two veterinary referral hospitals were reviewed (2018-2025) for cats with IMPN treated with hIVIg. Cats were treated with 1-2 g/kg hIVIg divided over 2-4 days (0.5 g/kg/day).Clinical information, diagnostic findings, treatment details and short- and long-term follow-up were evaluated retrospectively. Follow-up information was obtained from medical records and owner communication. Minimum follow-up duration was 8 months (8-51 months; median 17 months).Clinical course (partial and complete recovery, relapses) was compared between cats with acute/recent onset (4 cats) or chronic presentation (5 cats). Eight of nine cats exhibited clinical improvement following hIVIg administration, achieving ambulatory status (walking >5 steps) within a median of 4 days (2-8 days). One cat failed to respond to hIVIg but improved after subsequent prednisolone therapy. For the overall cohort, the median time to complete recovery was 20 days, while the median time to partial recovery was 14 days. Relapses occurred in four cats, but weakness was less severe, and all cats recovered again. The remaining five cats remained relapse-free. Human IVIg was well tolerated in this small cohort, and rapid clinical improvement was observed in most treated cats. These findings suggest that hIVIg may be considered as a treatment option in selected cats with IMPN, including those with acute and chronic presentations. Larger prospective studies, including comparison with no treatment or corticosteroids, are warranted to further assess its efficacy.

PMID 42544949
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PubMedCase reports in neurological medicine2026-08-02

Effective Treatment of Anti-GAD65 Limbic Encephalitis-Associated Epilepsy Despite Delayed Immunotherapy: A Brief Report.

Bughaith Ghadah G, Mahdi Ghadeer G, Ashkanani Mohammad M

A 44-year-old woman was referred to our epilepsy center for evaluation of refractory seizures persisting for 36 years. Diagnostic workup revealed anti-glutamic acid decarboxylase 65 limbic encephalitis (anti-GAD65 LE), supported by markedly elevated serum anti-GAD65 antibody titers and a compatible clinical presentation. Following initiation of a 6-month course of intravenous immunoglobulin (IVIG), seizure frequency decreased substantially, from 12 to 16 focal seizures per day to approximately one brief focal seizure per month. This was accompanied by improvements in cognition, psychiatric symptoms, and overall clinical function. This case highlights the potential for meaningful therapeutic response to immunotherapy despite prolonged diagnostic delay.

PMID 42539742
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PubMedCureus2026-08-02

Atypical Multifocal Motor Neuropathy Presenting With Isolated Spinal Accessory and Pectoral Nerve Involvement.

Tariq Amna A, Raza Syed Ali SA, Siddique Muhammad Sohaib MS

Multifocal motor neuropathy (MMN) is a rare, immune-mediated disorder typically characterized by slowly progressive, asymmetric distal limb weakness. Cranial nerve involvement is distinctly uncommon, and isolated involvement of the spinal accessory nerve (CN XI) is exceedingly rare. We present the case of a 68-year-old male patient who presented with severe neck and shoulder wasting and a profound head drop. Despite the fact that standard conduction studies failed to demonstrate classic motor conduction blocks due to the highly proximal nature of the nerve involvement, a clinical diagnosis of MMN was suspected based on the asymmetric motor-only presentation, elevated Anti-GM1 antibodies, and steroid nonresponsiveness. The patient showed a robust and sustained functional recovery following treatment with intravenous immunoglobulin (IVIG), highlighting the importance of clinical judgment in atypical presentations of treatable neuropathies.

PMID 42540390
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PubMedFrontiers in medicine2026-08-02

Case Report: Bullous erythema multiforme induced by omalizumab.

Tang Zenan Z, Zhao Yan Y

Bullous erythema multiforme (BEM) is an acute immune-mediated mucocutaneous disease, with drug induction being one of its common causes. Omalizumab, a recombinant humanized IgG1 monoclonal antibody targeting free IgE, is widely used in chronic spontaneous urticaria and asthma due to its favorable safety profile, while severe cutaneous bullous adverse reactions induced by it are extremely rare. We report a 36-year-old female patient with a history of bronchial asthma, allergic rhinitis, allergic conjunctivitis, and chronic spontaneous urticaria who developed generalized wheals. After the first subcutaneous injection of omalizumab 300 mg, multiple raised, edematous erythematous papules and plaques, vesicles, and bullae appeared on the trunk, limbs, palms, soles, and oral mucosa 17 days later, accompanied by fever, chills, and fatigue. Laboratory examinations showed elevated eosinophil count and IgE level, and skin biopsy from the left upper limb revealed focal epidermal necrotic keratinocytes, intraepidermal and subepidermal blister formation, and massive eosinophilic infiltration. The patient was diagnosed with omalizumab-induced BEM. Initial treatment with methylprednisolone combined with intravenous immunoglobulin (IVIG) was ineffective. The condition was successfully controlled after increasing the dose of methylprednisolone and adding oral upadacitinib. This case suggests that omalizumab may induce BEM, and combination therapy with high-dose glucocorticoids and JAK inhibitors may be an effective strategy for refractory cases. Clinicians should be alert to such rare adverse reactions when using omalizumab.

PMID 42539369
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