Drug Database
IM

immunoglobulin (Fovepta / Zutectra / Hepatect)

✓ Approved

Grifols, S.A. · Polyclonal Antibodies · Polyclonal Antibodies

What is immunoglobulin?

immunoglobulin is a polyclonal antibodies developed by Grifols, S.A.. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection or subcutaneous injection.

Drug Profile

Brand NamesFovepta, Zutectra, Hepatect
CompanyGrifols, S.A.
Drug ClassPolyclonal Antibodies, Recombinant Proteins, Antibody
RouteInjectable (Others), Intramuscular (IM) Injection, Subcutaneous Injection
StatusApproved

Therapeutic Indications

immunoglobulin is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsHepatitis B✓ Approved

Related Research Articles

PubMedJournal of clinical laboratory analysis2026-10-22

The Impact of Immunoglobulins on Cardiovascular Diseases and Lipid Profiles in Elderly and Middle-Aged Chinese Individuals: A 15-Year Retrospective Study.

Li Ya Y, Jiao Li L, Gao Yuan Y, Ni Xue-Feng XF

Humoral immunity defends via immunoglobulins. This study aimed to evaluate the association between immunoglobulins and CVDs and lipid profiles in a cohort of individuals aged 45 years and older. Data from 982 subjects were analyzed. The cohort had a median age of 61 years (IQR 56-72), was predominantly male (84.8%), and had a high prevalence of CVDs at baseline, including hypertension (30.3%), dyslipidemia (20.7%), arrhythmia (22.3%), coronary heart disease (12.1%), and atrial fibrillation (4.5%). Logistic regression analysis was used to examine the association between baseline and time-varying serum levels of IgG, IgA, and IgM and the presence of five CVDs: coronary heart disease, atrial fibrillation, arrhythmia, hypertension, and dyslipidemia. We additionally explored the relationship between these immunoglobulin levels and lipid profiles. No significant differences in immunoglobulin levels were found between CVD and non-CVD groups at baseline, and baseline immunoglobulin levels were not associated with any CVD. However, longitudinal changes in IgG and IgA levels were positively associated with changes in free fatty acids (FFAs). Intriguingly, longitudinal increases in IgM levels were positively associated with total cholesterol, LDL-C, non-HDL-C, and HDL-C. This study provides longitudinal evidence that increases in IgG and IgA levels are associated with elevated FFA levels, while increases in IgM are associated with an adverse lipid profile characterized by higher total cholesterol, LDL-C, and non-HDL-C, and lower HDL-C. These findings suggest a link between humoral immunity and lipid metabolism that warrants further investigation, with potential implications for cardiovascular risk assessment.

PubMedAmyloid : the international journal of experimental and clinical investigation : the official journal of the International Society of Amyloidosis2026-10-22

Quality standards for the diagnosis and management of ATTR and AL amyloidosis: a nominal group technique study.

Obici Laura L, Damy Thibaud T, Galan Lucia L, Moody William W et al.

Transthyretin (ATTR) and immunoglobulin light-chain (AL) amyloidosis are progressive conditions that can have debilitating effects on people. Delayed diagnosis and variable access to high-quality care continue to affect quality of life and prognosis. Clear and ambitious quality standards could drive consistent care and improve outcomes. A modified nominal group technique was used to develop consensus-based quality standards for the diagnosis and management of ATTR and AL amyloidosis. Eighteen experts participated, including patient representatives and clinicians from high-income, publicly funded health systems in Europe and Canada. Each quality standard was paired with at least one measurable indicator to support implementation and monitoring. A total of 29 provisional statements were generated, with consensus achieved on eight quality standards. These span the full care pathway and emphasise the need for timely, person-centred and interdisciplinary care. Twenty accompanying indicators were developed. This is the first comprehensive set of consensus-based quality standards for ATTR and AL amyloidosis care. They provide a practical and aspirational framework to guide quality improvement across health systems. Adoption of these standards could improve early diagnosis, equitable access to treatment, and quality of life. Future research may explore their feasibility and adaptation for other health system settings.

PubMedFrontiers in immunology2026-10-22

Case Report: Acute liver failure in systemic lupus erythematosus with autoimmune hepatitis-primary biliary cholangitis overlap: a belimumab-containing regimen and longitudinal follow-up.

Zhang Lina L, Zhang Tong T, Zhang Jing J, Wang Xiuhong X et al.

Severe autoimmune liver injury as the first manifestation of systemic lupus erythematosus (SLE) is rare, and concomitant autoimmune hepatitis-primary biliary cholangitis (AIH-PBC) overlap is uncommon. B-cell-activating factor (BAFF) provides a biological rationale for adjunctive therapy, although clinical evidence remains limited. A 72-year-old woman presented with 4 weeks of fatigue and anorexia and developed coagulopathy (international normalized ratio [INR] 1.8), ascites, and hepatic encephalopathy. Autoimmune testing showed antinuclear antibody 1:1280, high-titer anti-double-stranded DNA antibodies with hypocomplementemia, immunoglobulin G (IgG) 30.0 g/L, and antimitochondrial antibody positivity. Hepatitis B surface antigen, hepatitis C antibody, hepatitis E antibody, and Epstein-Barr virus and cytomegalovirus DNA tests were negative. Liver biopsy 42 days after corticosteroid initiation demonstrated interface hepatitis, destructive small-bile-duct injury, plasma cell-rich inflammation, and Batts-Ludwig stage 2 fibrosis without cirrhosis, supporting a clinicopathologic diagnosis of AIH-PBC overlap. Previously unrecognized chronic autoimmune liver disease could not be excluded. Prednisolone was started at 50 mg/day, followed 10 days later by intravenous belimumab, with concomitant ursodeoxycholic acid. Tacrolimus was added during maintenance. By 10 October 2025, liver biochemistry had improved, IgG was 9.42 g/L, and prednisolone had been reduced to 2.5 mg/day. Liver stiffness decreased from 21.5 to 9.7 kPa. Sustained biochemical improvement occurred during a belimumab-containing multidrug regimen. This observation does not establish the independent efficacy of belimumab or histological regression of fibrosis.

PubMedThe Journal of the Association of Physicians of India2026-10-22

Beyond Fever-The Changing Face of Acute Leptospirosis: A Retrospective Observational Study from Western India.

Agarwal Arun A, Choudhary Sachin S, Agarwal Aakanksha A, Raval Hetashree H et al.

Leptospirosis is a zoonotic infection caused by pathogenic Leptospira species and remains a significant cause of acute febrile illness in tropical regions. Its clinical spectrum ranges from mild, self-limiting illness to severe multi-organ dysfunction. The disease is broadly classified into anicteric and icteric (Weil's disease) forms, the latter associated with jaundice and increased morbidity. In India, diagnosis is often challenging due to overlapping features with other endemic infections such as dengue and scrub typhus. Coinfections and changing epidemiological patterns, including increasing urban cases, further complicate clinical assessment. This study evaluated the demographic profile, clinical characteristics, organ involvement, coinfections, severity, management, and outcomes of adults hospitalized with acute leptospirosis, with comparison between icteric and anicteric phenotypes. This retrospective observational study included 78 adults with laboratory-confirmed acute leptospirosis admitted over 30 months to a tertiary care hospital in Rajasthan, India. Diagnosis was established by positive Leptospira-specific immunoglobulin M (IgM) serology (>11 NTU) and/or polymerase chain reaction (PCR). Data regarding demographics, comorbidities, clinical features, organ involvement, coinfections, treatment, and outcomes were extracted from medical records. Organ involvement was defined using predefined clinical and laboratory criteria across major systems. Severe disease was defined as dysfunction of two or more organ systems. Icteric leptospirosis was defined by clinical jaundice and/or serum bilirubin ≥3 mg/dL. Coinfections were confirmed through appropriate laboratory testing. Continuous variables were expressed as median (interquartile range) and categorical variables as frequency (%). Subgroup comparisons were performed using the Mann-Whitney U test and Fisher's exact test. The median age was 57 years (interquartile range 41-68), with slight male predominance (52.6%). Although 59% of patients were from rural areas, 41% were urban residents. Hypertension (25.6%) and diabetes mellitus (29.5%) were common comorbidities, while 42.3% had no prior illnesses. Anicteric disease predominated (84.6%), and 15.4% had icteric leptospirosis. Fever was present in 93.6% of patients. Hepatic (69.2%) and respiratory (66.7%) involvement were most frequent, and multi-organ dysfunction occurred in 61.5%. Coinfections were identified in 52.6% of cases, most commonly dengue (17.9%) and scrub typhus (14.1%). Coinfected patients were younger and had fewer comorbidities, with lower rates of renal, respiratory, and neurological involvement and reduced need for ventilatory support. Icteric patients were significantly younger (median 31.5 vs 58 years) and had longer hospital stays (10.5 vs 7 days). Hepatic involvement was universal in the icteric group, and secondary hemophagocytic lymphohistiocytosis (HLH) was markedly more frequent. Mortality was higher among icteric patients but did not reach statistical significance. Mechanical ventilation was required in 10.3% of patients. The median hospital stay was 7 days, and overall mortality was 2.6%, with both deaths occurring in patients with severe multi-organ dysfunction. Acute leptospirosis exhibits diverse clinical presentations with frequent multi-organ involvement in hospitalized adults. Coinfections are common but did not consistently worsen outcomes. Icteric disease represents a more severe phenotype associated with greater complications and prolonged hospitalization. Early diagnosis and timely supportive management are critical to achieving favorable outcomes in endemic settings.

PubMedTransfusion2026-10-21

Passive acquisition of hepatitis B virus antibodies after allogeneic hematopoietic cell transplantation.

Konuma Takaaki T, Monna-Oiwa Maki M, Nagai Etsuko E, Kato Seiko S et al.

Newly positive hepatitis B virus (HBV) serologic results after allogeneic hematopoietic cell transplantation (HCT) may reflect passive antibody transfer from blood-derived products rather than HBV infection. We investigated the incidence and temporal patterns of hepatitis B surface antibody (anti-HBs) and antibody to hepatitis B core antibody (anti-HBc) acquisition after allogeneic HCT. We retrospectively evaluated 193 adults who underwent allogeneic HCT for hematologic diseases between May 2012 and March 2025 at a single institution in Japan. Anti-HBs, anti-HBc, and hepatitis B surface antigen (HBsAg) were assessed before and after HCT. Among 180 patients who were anti-HBc negative before HCT, 6 (3.3%) developed anti-HBc positivity after HCT. Among 164 patients who were anti-HBs negative before HCT, 49 (29.9%) developed anti-HBs positivity. All patients with newly detectable antibodies remained HBsAg negative, and available HBV DNA measurements showed no evidence of active HBV infection. Among patients with subsequent follow-up measurements, anti-HBc disappeared in 3 of 3 evaluable patients after a median of 240 days, whereas anti-HBs declined or disappeared in 30 of 32 evaluable patients after a median of 119 days. Among patients receiving neither fresh frozen plasma nor intravenous immunoglobulin, anti-HBs concentrations increased significantly after HCT (p< .0001), with a greater increase among those receiving ≥24 versus ≤23 platelet transfusions (p = .0437). Newly detectable HBV antibodies were common after HCT without virologic evidence of infection, suggesting passive antibody transfer from cellular blood components, particularly platelets.

PubMedVox sanguinis2026-10-20

Access to hepatitis B immunoglobulin in Burkina Faso.

Belem Wendimi Fatimata WF, Barro Lassina L, Nezien Desiré D, Burnouf Thierry T

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