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Drug Database
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

PubMedDiseases (Basel, Switzerland)2026-10-26

The Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis Spectrum: A Report of Two Contrasting Cases Managed in a Burn Unit.

Constantinescu Mihai-Codrin MC, Moraru Dan-Cristian DC, Poroch Vladimir V, Avadanei-Luca Stefana S et al.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe, potentially life-threatening mucocutaneous reactions classified based on body surface area (BSA) involvement: SJS affects less than 10% BSA, SJS/TEN overlap affects 10-30% BSA, and TEN affects more than 30% BSA. The mortality rates range from 4.8-9% for SJS to 14.8-48% for TEN. Treatment remains controversial, with corticosteroids and intravenous immunoglobulin (IVIg) being the most debated therapeutic options. While some studies suggest IVIg may block Fas-mediated keratinocyte apoptosis, meta-analyses have shown conflicting results regarding mortality benefit. We describe two patients from opposite ends of the SJS/TEN spectrum, managed in a burn unit with different therapeutic approaches. The first patient, a 47-year-old man with systemic lupus erythematosus, developed TEN with approximately 35% body surface area involvement, complicated by sepsis and rhabdomyolysis; he was treated with systemic corticosteroids and intravenous immunoglobulin (IVIg, 0.4 g/kg/day for 3 days). The second patient, a 66-year-old woman, developed SJS attributed to amoxicillin-clavulanic acid and was treated with systemic corticosteroids alone. Both patients achieved complete re-epithelialization without major sequelae. These two cases illustrate the clinical heterogeneity of the SJS/TEN spectrum and the central role of early recognition, prompt withdrawal of the culprit drug, transfer to a specialized unit, and multidisciplinary supportive care. Given the substantial differences between the two patients in age, sex, comorbidities, culprit drugs, and disease severity, no comparative or causal inference regarding the relative efficacy of the two treatment strategies can be drawn; no efficacy claim is made for either therapeutic approach; this report is descriptive, and the two cases are presented as contrasting rather than comparable.

PMID 42929981
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PubMedCurrent oncology (Toronto, Ont.)2026-10-26

Clinical and Laboratory Factors Associated with Serious Infections in Multiple Myeloma: A Real-World Study.

Odabaşı Giden Aslı A, Şahin Onur O, Ozatli Duzgun D

Background: Serious infections remain a major cause of morbidity and treatment disruption in patients with multiple myeloma (MM). Identifying readily available clinical factors associated with infectious complications may facilitate risk-adapted supportive care. This study evaluated clinical and laboratory factors associated with serious infection in patients with MM, including the potential association of baseline neutrophil-to-lymphocyte ratio (NLR) with subsequent serious infectious complications. Methods: This retrospective multicenter cohort study included 104 patients with MM. Baseline demographic, disease-related, treatment-related, and laboratory characteristics were evaluated. Serious infection was defined as an infectious episode requiring hospitalization. Infectious events were recorded throughout follow-up, including those occurring during second-line and subsequent therapies. Associations with serious infection were assessed using univariate and multivariable binary logistic regression analyses. The primary multivariable model included age, International Staging System (ISS) stage, dialysis requirement at diagnosis, treatment response, and baseline NLR. Results: Serious infections occurred in 39 patients (37.5%). Dialysis requirement at diagnosis (30.8% vs. 4.6%, p = 0.001), failure to achieve treatment response (51.3% vs. 7.7%, p < 0.001), hypogammaglobulinemia (48.7% vs. 29.2%, p = 0.046), and IVIG administration (76.9% vs. 46.2%, p = 0.002) were more frequent among patients with serious infection. Baseline NLR did not differ significantly between patients with and without serious infection. In the multivariable model, dialysis requirement at diagnosis (adjusted OR 8.26, 95% CI 1.81-37.68; p = 0.006) and failure to achieve treatment response (adjusted OR 16.77, 95% CI 4.37-64.31; p < 0.001) were independently associated with serious infection, whereas age, ISS stage, and baseline NLR were not. Conclusions: Serious infections were common in this real-world MM cohort. Dialysis requirement at diagnosis and failure to achieve treatment response were independently associated with serious infection, whereas baseline NLR was not independently associated with serious infectious complications. These findings suggest that clinical characteristics reflecting renal dysfunction and treatment response may be useful for identifying patients at increased risk of serious infection. The observed association between IVIG administration and serious infection should be interpreted cautiously because of potential confounding by indication and reverse causality.

PMID 42930182
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PubMedCureus2026-10-26

Bilateral Earlobe Purpura as an Unusual Initial Manifestation of Systemic Lupus Erythematosus: A Case Report.

Atherton Lucy L

Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by autoantibody production, particularly antinuclear antibodies (ANAs). The broad clinical spectrum and absence of pathognomonic features can make diagnosis challenging, particularly when alternative autoimmune, infectious, and hematological conditions must be considered. We report a case of a 31-year-old woman who presented to the emergency department with a two-week history of bilateral earlobe purpura. Initial investigations demonstrated severe thrombocytopenia and normocytic anemia, and subsequent imaging revealed widespread lymphadenopathy. Early multidisciplinary assessment by acute medicine, hematology, and rheumatology, together with exclusion of hematological malignancy and positive autoimmune serology, supported a diagnosis of SLE. Despite initial treatment with intravenous immunoglobulin (IVIg) and corticosteroids, the bicytopenia persisted. Mycophenolate mofetil was commenced; however, worsening cytopenias and concern for secondary hemophagocytic lymphohistiocytosis led to the initiation of rituximab infusions. Her platelet count subsequently improved, and she was discharged with rheumatology and hematology follow-up. This case highlights an unusual cutaneous presentation of newly diagnosed SLE and the diagnostic challenges associated with severe hematological involvement at initial presentation. It also demonstrates the importance of multidisciplinary assessment and timely escalation of immunosuppressive therapy in severe disease.

PMID 42928827
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PubMedPediatrics international : official journal of the Japan Pediatric Society2026-10-25

BCG Scar Reactivation (BCGitis) in Kawasaki Disease: A Scoping Literature Review.

Khreis Dima D, Sulaiman Alena A, Abusalah Yara Y, Hanna-Wakim Rima R et al.

Bacillus Calmette-Guérin (BCG) scar reactivation (BCGitis) is a distinctive clinical sign reported in Kawasaki disease (KD), yet evidence remains scarce across the literature. We aimed to summarize the epidemiology, chronology, clinical correlates, and coronary outcomes associated with BCGitis in KD. We conducted a PRISMA-ScR-guided scoping review of studies describing BCGitis in KD. Data were synthesized descriptively across retrospective cohorts and case reports/series. Forty studies published between 1997 and 2024 were included (10 retrospective cohorts; 30 reports of 36 cases). BCGitis was most frequently described in infants and young children (< 2 years, often < 6-12 months) and was commonly associated with earlier recognition and treatment. Reported BCGitis prevalence varied across cohorts, from 11.8% to 49.9%. Coronary artery lesions (CAL) and IVIG resistance were reported at lower rates in some cohorts; however, these findings were not statistically significant. In the case reports, most patients were infants, male predominance was observed, and incomplete KD was frequent. BCGitis was often reported during the early febrile phase, sometimes preceding complete KD diagnostic criteria. Most reported cases responded to IVIG. Coronary abnormalities were usually mild or transient, although two giant aneurysms, one case of Kawasaki disease shock syndrome, and one mortality were reported. BCGitis may support earlier recognition of KD, particularly in incomplete presentations, potentially facilitating timely recognition and treatment. Incorporation of BCGitis into diagnostic algorithms may improve patient outcomes. Future studies should standardize reporting of BCGitis chronology, coronary outcomes, and evaluate the incremental diagnostic value of BCGitis in prospective cohorts.

PMID 42922148
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PubMedCase reports in dermatology2026-10-25

Acute Management of Refractory Bullous Pemphigoid Using Plasma Exchange and Granulocyte-Monocyte-Apheresis: A Case Report.

Ciobanu Georgiana G, Reichinger Erich E, Saulite Ieva I, Cozzio Antonio A et al.

Bullous pemphigoid (BP) is a chronic autoimmune blistering disorder, characterized by subepidermal blister formation and intense pruritus, predominantly affecting older adults. Its pathogenesis is complex and only partially understood, involving both humoral and cellular immune mechanisms. Current treatment strategies rely primarily on topical or systemic corticosteroids, depending on disease extent. However, the long-term use of corticosteroids is often constrained by substantial toxicity, prompting the use of steroid-sparing agents such as methotrexate, rituximab, and other immunomodulatory therapies. Nevertheless, the management of BP remains challenging, particularly in refractory cases, due to frequent relapses and treatment-associated adverse events. We report the case of a 67-year-old woman with long-standing refractory BP and multiple relapses despite various therapeutic interventions, including dupilumab. Due to persistent disease activity, therapeutic plasma exchange was performed, resulting in marked clinical improvement and allowing subsequent maintenance therapy with intravenous immunoglobulin (IVIg). Six months later, however, she developed a severe flare with progressive blistering that remained refractory to high-dose systemic corticosteroids. Following repeat plasma exchange and subsequent granulocyte-monocyte apheresis (GMA), a marked clinical response was observed, with achievement of sustained clinical remission. In this case of severe refractory BP, sequential extracorporeal therapies were temporally associated with disease control. Plasma exchange followed by IVIg was associated with an initial clinical response, whereas repeat plasma exchange and subsequent GMA coincided with remission during a later inflammatory relapse. Although a causal relationship cannot be established from a single case, these observations suggest that tailored extracorporeal approaches including GMA may represent a valuable therapeutic option in selected patients with severe, treatment-refractory BP and warrant further investigation.

PMID 42923975
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PubMedFrontiers in neurology2026-10-25

Polyclonal IgG therapy in neurologic and neuromuscular disease: mechanisms of action and insights from newer therapies.

Berger Mel M

Plasma-derived polyclonal IgG (IVIG or SCIG) has become the mainstay of therapy for autoimmune peripheral neuropathies including Guillain-Barre Syndrome, Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP) and Multifocal Motor Neuropathy, as well as Myasthenia Gravis. Use in these diseases exceeds that for all immune deficiencies combined. Laboratory and animal studies suggest many diverse mechanisms of action of IgG on cellular and humoral immunity. However, the spectrum of immune-mediated diseases in which IgG is efficacious is largely limited to conditions mediated by autoantibodies and/or complement. Careful analysis of clinical results indicates that only a few mechanisms are physiologically relevant: anti-idiotype neutralization, accelerated catabolism of IgG autoantibodies, and blockade of complement activation and deposition. These MOAs likely operate simultaneously and may contribute synergistically to the overall efficacy of IgG. Importantly, IgG does not act as a disease modifying drug, and repeat dosing at regular intervals is necessary in chronic diseases. This review seeks to provide a firm basis for understanding the mechanisms of action in vivo, and to provide benchmarks for understanding the effects and uses of new agents that have been recently approved and/or are under development.

PMID 42921078
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