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IGIV3I Grifols
IGIV3I is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune responses.
IGIV3I is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune responses. Used for Primary immunodeficiency disorders, Secondary immunodeficiency conditions, Autoimmune and inflammatory disorders.
At a glance
| Generic name | IGIV3I Grifols |
|---|---|
| Also known as | IGIV |
| Sponsor | Instituto Grifols, S.A. |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Target | Fc receptors, complement system, pathogenic antigens |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
IGIV3I Grifols is a human immunoglobulin G (IgG) preparation derived from pooled plasma of multiple donors. It functions through multiple mechanisms including opsonization of pathogens, complement activation, Fc receptor engagement on immune cells, and immune modulation to restore or enhance immune function in immunodeficient or dysregulated states.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency conditions
- Autoimmune and inflammatory disorders
Common side effects
- Headache
- Fever
- Chills
- Infusion site reactions
- Thromboembolism
- Renal dysfunction
Key clinical trials
- IGIV Study for Chronic ITP Patients Ages 3-70 (PHASE3)
- Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura (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 |