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IGIV3I Grifols 10%
IGIV3I is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune responses and provide immunoprotection.
IGIV3I is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering pooled human antibodies to modulate immune responses and provide immunoprotection. Used for Primary immunodeficiency disorders, Secondary immunodeficiency, Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy).
At a glance
| Generic name | IGIV3I Grifols 10% |
|---|---|
| Also known as | Intravenous immunoglobulin |
| Sponsor | Grifols Biologicals, LLC |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
IGIV3I 10% is a human immune globulin intravenous (human) preparation derived from pooled plasma of multiple donors. It functions by supplying exogenous immunoglobulins that can neutralize pathogens, opsonize antigens, modulate complement activation, and regulate inflammatory immune responses through Fc receptor engagement on immune cells.
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
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IGIV3I Grifols 10% CI brief — competitive landscape report
- IGIV3I Grifols 10% updates RSS · CI watch RSS
- Grifols Biologicals, LLC portfolio CI