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Gamunex Intravenous Immunoglobulin
Gamunex is an intravenous immunoglobulin (IVIG) that provides passive immunity by supplying pooled human antibodies to enhance immune function and modulate inflammatory responses.
Gamunex is an intravenous immunoglobulin (IVIG) that provides passive immunity by supplying pooled human antibodies to enhance immune function and modulate inflammatory responses. Used for Primary immunodeficiency disorders, Secondary immunodeficiency, Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy).
At a glance
| Generic name | Gamunex Intravenous Immunoglobulin |
|---|---|
| Sponsor | National Institute of Mental Health (NIMH) |
| Drug class | Intravenous Immunoglobulin (IVIG) |
| Target | Fc receptors, complement system, pathogenic antigens |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
IVIG works by delivering a broad spectrum of immunoglobulins (primarily IgG) from pooled human plasma donors, which can neutralize pathogens, opsonize antigens for clearance, and modulate immune responses through Fc receptor engagement and complement inhibition. This mechanism supports both antibody-deficient patients and those with dysregulated immune responses. The product is used in immunodeficiency disorders and certain autoimmune/inflammatory conditions.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency
- Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy)
Common side effects
- Headache
- Fever
- Chills
- Myalgia
- Infusion reactions
- Thrombosis (rare)
Key clinical trials
- A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (PHASE3)
- A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma (PHASE3)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm
- Determinants of Digestive Morbidity in Neonatal Jaundice
- Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (PHASE3)
- A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (PHASE3)
- A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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