Drug Database
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 immunology2026-10-15

A lipid-related transcriptomic signature for distinguishing Kawasaki disease from febrile infections: a Mendelian randomization and machine-learning study.

Wang Sibao S, Luo Gang G, Ji Zhixian Z, Zhou Guoxiang G et al.

Kawasaki disease (KD) diagnosis remains challenging because no pathognomonic test exists and the clinical presentation overlaps extensively with common childhood infections. Acute KD is accompanied by reproducible lipid perturbations, yet whether these changes are causally linked to the innate immune-driven vascular damage of KD vasculitis is unestablished. We aimed to derive a lipid-related transcriptomic signature for distinguishing KD from febrile infections and to characterize its relationship with innate immune remodeling. Bidirectional two-sample Mendelian randomization (MR) screened 422 candidate exposures (419 lipid/metabolic traits and three immune-cell phenotypes) against two independent KD GWAS cohorts, with multiplicity correction. Differentially expressed genes from a training cohort comparing KD with rigorously classified febrile controls were intersected with a broad lipid-metabolism-related GeneCards set, yielding 459 candidates. The 459 candidates were evaluated across 130 machine-learning combinations; a full-training LASSO fit at lambda.1se yielded a 12-gene candidate panel, and the saved penalized model was applied unchanged to an independent cohort without batch correction. The immune microenvironment was estimated using CIBERSORT, acute-to-convalescent expression changes were tracked longitudinally, and selected markers were assessed in TNF-α-stimulated HUVECs. No exposure survived correction for the 422 tests performed (minimum Benjamini-Hochberg q = 0.979). All nine discovery-stage nominal hits were evaluated in a second KD GWAS; eight had directionally concordant point estimates, but none reached an unadjusted P < 0.05 in the second cohort. The frozen penalized model achieved an external AUC of 0.851 (95% CI 0.768-0.934) in GSE68004 without cross-cohort batch correction. CIBERSORT indicated a higher estimated neutrophil fraction in KD, concordant with a mature-neutrophil marker score from the same matrix. CETP, KREMEN1, and CCL23 were lower in convalescent samples after IVIG (all FDR < 0.0001) and were induced in TNF-α-treated HUVECs, together with VCAM-1, ICAM-1, and IL-8. The frozen penalized model showed moderate discrimination between KD and febrile controls, but the selected 12-gene set represents one candidate realization of a partition-sensitive modeling pipeline. KREMEN1 warrants separate biological study on the basis of marginal, longitudinal, and immune-association findings rather than its selection stability. Recalibration and prospective validation are required before clinical use. The HUVEC findings are transcriptional and hypothesis-generating.

PMID 42876671
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PubMedTranslational pediatrics2026-10-13

Age-related clinical characteristics of respiratory syncytial virus infection in hospitalized children: a retrospective study.

Wang Shuying S, Huang Bing B, Ding Yingxue Y

Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infections in children, yet age-stratified clinical characteristics of hospitalized children with RSV infection remain incompletely defined. This study aimed to compare the clinical manifestations, laboratory parameters, co-infections, and disease severity between hospitalized children with RSV infection aged ≤3 years and those aged >3 years, so as to provide evidence for age-stratified diagnosis, treatment, and prevention of RSV infection. A total of 624 hospitalized children with RSV infection admitted to Beijing Friendship Hospital, Capital Medical University, from 2023 to 2025 were retrospectively enrolled. Based on age at admission, patients were stratified into two groups: ≤3 years (n=434) and >3 years (n=190). Demographic characteristics, clinical manifestations, laboratory parameters, etiological findings, and treatment data were collected. Intergroup comparisons were performed using the χ2 test, Fisher's exact test, Mann-Whitney U test, or independent samples t-test, as appropriate. Compared with the ≤3 years group, the >3 years group had higher rates of fever (92.6% vs. 79.5%), longer fever duration (6 vs. 5 days), severe pneumonia (13.7% vs. 6.7%), co-infection (47.4% vs. 26.0%), and longer disease course (10 vs. 8 days) (all P<0.001, except severe pneumonia P=0.005). Co-infection with Mycoplasma pneumoniae (33.7% vs. 10.1%) and other viruses (20.0% vs. 12.7%) was also more frequent in the >3 years group (all P<0.05). The ≤3 years group showed higher wheezing rates (22.6% vs. 6.3%, P<0.001). Laboratory findings revealed higher neutrophil counts (3.16×109/L vs. 2.44×109/L) and C-reactive protein (CRP) levels (3.5 vs. 1.3 mg/L) but lower white blood cell (WBC) count and lymphocyte counts in the >3 years group (all P<0.001). Glucocorticoid (11.6% vs. 7.8%) and intravenous immunoglobulin (IVIG) use (1.1% vs. 1.2%) were comparable between groups (P>0.05). Compared with children aged ≤3 years, hospitalized children aged >3 years with RSV infection had higher proportions of fever, prolonged disease course, co-infection, and severe pneumonia. Early recognition and dynamic assessment should be emphasized in this age group to avoid underestimating disease severity based on age alone.

PMID 42866192
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PubMedFrontiers in cardiovascular medicine2026-10-13

Associated factors for in-hospital mortality in patients with fulminant myocarditis: a systematic review and meta-analysis.

Zhou Haojie H, Zhang Qiang Q, Zheng Xi X, Zhao Guifeng G et al.

Fulminant myocarditis (FM) progresses rapidly and carries high all-cause in-hospital mortality. Patients in the early phase often develop cardiogenic shock and malignant ventricular arrhythmias, with widely varying mortality rates reported across studies. Existing single-center cohorts yield conflicting prognostic findings with marked cross-cohort heterogeneity, and no standardized meta-analysis with GRADE certainty grading has been published to guide risk stratification. This meta-analysis pooled prognostic associations of all-cause in-hospital mortality in FM to inform acute risk evaluation and personalized care. Eleven Chinese and English electronic databases were searched from database establishment through June 2025. Eligible studies were observational cohorts reporting prognostic associations of all-cause in-hospital mortality among FM patients. Two independent reviewers completed screening, data extraction and quality assessment separately. The Newcastle-Ottawa Scale (NOS) and AHRQ checklist were adopted to evaluate methodological quality. Pooled analyses were performed via the statsmodels package in Python, and the GRADE framework was applied to rate the certainty of evidence. 26 retrospective cohort studies with 4,890 FM patients were enrolled. Ten potential factors were meta-analyzed, of which six showed statistically significant associations with in-hospital mortality (P < 0.05), including age (OR = 1.03, 95% CI: 1.02-1.04), cardiac arrest or CPR (OR = 2.57, 95% CI: 1.49-4.44), lactate (OR = 1.08, 95% CI: 1.00-1.16), cTnI (OR = 1.04, 95% CI: 1.01-1.07), LVEF (OR 0.94, 95% CI 0.90-0.97), and intravenous immunoglobulin therapy (OR = 0.12, 95% CI: 0.02-0.86). CK-MB, serum creatinine, total bilirubin, and VT/VF showed no statistically significant association (all P > 0.05). GRADE evidence ratings indicated low-certainty evidence for age and cTnI, and very-low-certainty evidence for the remaining significant factors. Sensitivity analyses indicated unstable pooled estimates for lactate and intravenous immunoglobulin therapy. Four factors showed positive associations with elevated all-cause in-hospital mortality. LVEF was inversely associated with mortality, whereas the inverse association for IVIG represents a fragile treatment-related signal. These findings may inform acute risk screening, but most associations were supported by low or very low certainty evidence and should not be interpreted as causal. All included data were derived from retrospective cohorts. Standardized multicenter prospective studies are required to verify these prognostic associations. https://www.crd.york.ac.uk/PROSPERO/view/CRD420261399446, identifier CRD420261399446.

PMID 42865794
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PubMedMuscle & nerve2026-10-12

The Duke Myasthenia Gravis Clinic Registry: IV. Does Race Affect the Outcome of Treatment of Myasthenia Gravis? A Single Center Retrospective Analysis.

Liu Mao M, Ma Chunlu C, Lutz Michael W MW, Juel Vern C VC et al.

Few studies have investigated the role of race in the long-term outcome of patients with myasthenia gravis (MG). The aim of this study is to analyze clinical characteristics and treatment outcomes related to race in patients with MG. This is a retrospective review of data from patients seen between 1980 and 2016 and followed for at least 2 years in the Duke MG Clinic. Treatment goal (TG) was defined as achieving MGFA postintervention status of "minimal manifestations" or better. Multivariable logistic regression analysis and Cox proportional hazards (CPH) modeling were performed to assess the effect of race on TG by adjusting for other variables. Among 820 patients (661 White, 81%; 159 Black, 19%), Black patients had a younger median age at disease onset, female predominance, higher rate of muscle-specific tyrosine kinase antibodies and thymectomy, and less non-corticosteroid immunosuppressant use. The percentage of White patients in the Registry is greater than the mean in the North Carolina census between 1980 and 2010 (81% vs. 77%, p = 0.014). Disease duration and MGFA class at first visit, thymectomy, follow-up duration, median time to TG, TG achievement and maintenance, median time to TG loss, and corticosteroid/PLEX/IVIG use were similar in the two racial groups. Neither multivariable logistic regression nor CPH modeling identified race as an independent predictor of TG. Although racial differences were observed in patients with MG, long-term outcomes were similar in Black and White patients. Our study suggests that following treatment guidelines is important in achieving favorable MG outcomes.

PMID 42860830
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PubMedPathology2026-10-11

Immunoglobulin products and neuronal antibody assays: implications in clinical interpretation.

Cecchin Amelia A, Reynolds Claire C, Pucar Phillippa A PA, King Jovanka J et al.

Immunoglobulin (Ig) products are prescribed for the treatment of a range of immune-mediated disorders, including autoimmune neurological disease. Both intravenous immunoglobulin (IVIg) and subcutaneous immunoglobulin (SCIg) formulations are available. While Ig products can interfere with immunoassay result interpretation, their influence on neuronal antibody screening methods specifically is unknown. Twenty-five Ig products were sourced and processed at 10 g/L to reflect physiological IgG levels, with these preparations then subjected to the manufacturer-recommended dilution protocols for neuronal line immunoassay (LIA), neuronal tissue indirect immunofluorescence (IIF) and glutamic acid decarboxylase (GAD) 65 enzyme-linked immunosorbent assay (ELISA). To provide clinical context, three cases are illustrated, specifically for GAD65 ELISA and Ig interference. Both IVIg and SCIg demonstrated variable positivity across neuronal LIA, tissue IIF and GAD65 ELISA. At 10 g/L, 16 of 25 (64%) products were positive by neuronal LIA, with a median signal intensity of 19 (1+), whereas no products were positive at the manufacturer-recommended dilution. In six individual batches, a reproducible antibody profile was observed (GAD65, CV2/CRMP5, Titin, Zic4). Positive neuronal tissue IIF staining was observed for all Ig products at the manufacturer-recommended dilution and for 22 of 25 (88%) of products at 10 g/L; however, the patterns were non-specific and showed no correlation with LIA or GAD65 ELISA results. On average, GAD65 ELISA titres were elevated for all Ig products: 200.5 IU/mL at 10 g/L and 441.4 IU/mL for neat preparations. Three patients developed positive GAD65 ELISA results after IVIg, having previously shown no detectable titres. Immunoglobulin-related assay interference was observed under experimental conditions, with variations likely attributable to pooled donor Ig, product matrices and the working dilution. Under routine concentrations, the diagnostic applicability of these findings varied by assay. Collectively, these findings highlight the need for cautious interpretation of results if performed after the administration of Ig products.

PMID 42859103
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PubMedJournal of the neurological sciences2026-10-11

Re-treatment of Guillain-Barré syndrome (GBS) in the post-SID-GBS trial era.

Mayman Naomi N, Schneider Andrea L C ALC, Karam Chafic C

Combining plasma exchange (PE) and intravenous immunoglobulin (IVIG) or sequential treatment courses in Guillain-Barré syndrome (GBS) has not been shown to provide additional benefit over single-course treatment. However, the extent to which re-treatment persists in clinical practice remains unknown. In this study, we aimed to determine the frequency of retreatment, identify factors associated with re-treatment, and compare outcomes between single-treatment and retreated patients. All patients who underwent inpatient electromyography and nerve conduction studies (EMG/NCS) at the Hospital of the University of Pennsylvania between July 1, 2019 and May 30, 2025 were screened to identify those diagnosed with GBS. Demographics, treatment details, and outcome (defined by GBS disability score [GBS-DS]) were extracted from clinical records and compared between patients receiving single treatment versus retreatment using t-tests for continuous variables and Fisher's exact tests for categorical variables. Sixty-eight GBS patients were included. Ten patients who did not improve within 1 week after their first treatment were re-treated. There were no significant predisposing factors for re-treatment. Outcome at 6 months was similar between those who were re-treated versus those who were not. Most re-treated patients received more than one round of re-treatment. The most common reasons for re-treatment included clinical worsening or plateau and patient perception of returning symptoms. A substantial minority of GBS patients continued to receive re-treatment at this single academic medical center despite lack of supporting evidence. The absence of clear clinical variables associated with retreatment suggests that non-evidence-based factors may influence these decisions.

PMID 42858721
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