Last reviewed · How we verify
IGIV GAMUNEX®-C
IGIV Gamunex-C is an intravenous immunoglobulin (IVIG) that provides passive immunity by supplying pooled human antibodies to help patients fight infections and modulate immune responses.
IGIV Gamunex-C is an intravenous immunoglobulin (IVIG) that provides passive immunity by supplying pooled human antibodies to help patients fight infections and modulate immune responses. Used for Primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, common variable immunodeficiency), Secondary immunodeficiency in hematologic malignancies, Chronic inflammatory demyelinating polyneuropathy (CIDP).
At a glance
| Generic name | IGIV GAMUNEX®-C |
|---|---|
| Also known as | Immune Globulin Infusion (Human), Intravenous immunoglobulin G, Approved IGIV product for US sites |
| Sponsor | Baxalta now part of Shire |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Target | Fc receptors, complement system, pathogenic antigens |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Gamunex-C contains immunoglobulin G (IgG) antibodies derived from pooled human plasma that provide immediate passive immunity against pathogens. It works by replacing deficient or dysfunctional antibodies in immunocompromised patients and can modulate inflammatory immune responses through multiple mechanisms including Fc receptor engagement and complement inhibition. The formulation is stabilized with maltose and is administered intravenously to treat primary immunodeficiency disorders and certain autoimmune/inflammatory conditions.
Approved indications
- Primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, common variable immunodeficiency)
- Secondary immunodeficiency in hematologic malignancies
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Multifocal motor neuropathy (MMN)
Common side effects
- Headache
- Fever
- Chills
- Fatigue
- Nausea
- Infusion site reactions
- Aseptic meningitis
- Thromboembolism
Key clinical trials
- LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis (PHASE2, PHASE3)
- Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases (PHASE2, PHASE3)
- A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (PHASE3)
- Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia (PHASE1, PHASE2)
- Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients. (PHASE3)
- Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP (PHASE2)
- Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis (PHASE2)
- Immune Globulin Intravenous (IGIV) For 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IGIV GAMUNEX®-C CI brief — competitive landscape report
- IGIV GAMUNEX®-C updates RSS · CI watch RSS
- Baxalta now part of Shire portfolio CI