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IGIV-C 10%
IGIV-C 10% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to modulate immune responses.
IGIV-C 10% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to modulate immune responses. Used for Primary immunodeficiency disorders, Secondary immunodeficiency conditions, Autoimmune and inflammatory disorders.
At a glance
| Generic name | IGIV-C 10% |
|---|---|
| Also known as | Immune Globulin Injection 10% Caprylate/Chromatography |
| Sponsor | Grifols Therapeutics LLC |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
IGIV-C is a polyclonal immunoglobulin G (IgG) product derived from pooled human plasma that contains a broad spectrum of antibodies. It functions through multiple mechanisms including opsonization of pathogens, complement activation, Fc receptor engagement, and immune modulation to treat primary immunodeficiencies and autoimmune/inflammatory conditions. The 10% concentration allows for higher-dose administration with reduced infusion volumes.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency conditions
- Autoimmune and inflammatory disorders
Common side effects
- Headache
- Fever
- Chills
- Infusion site reactions
- Nausea
- Thrombotic events
- Aseptic meningitis
Key clinical trials
- 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)
- Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases (PHASE2, PHASE3)
- The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes (PHASE2)
- Randomised Evaluation of COVID-19 Therapy (PHASE3)
- A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants (PHASE1)
- IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3 (PHASE2)
- A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency (PHASE3)
- A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (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 |