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IGSC 20% infusion
IGSC 20% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins.
IGSC 20% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by delivering pooled human antibodies to modulate immune function and replace deficient immunoglobulins. Used for Primary immunodeficiency disorders, Secondary immunodeficiency, Autoimmune and inflammatory conditions (e.g., ITP, CIDP, myasthenia gravis).
At a glance
| Generic name | IGSC 20% infusion |
|---|---|
| Also known as | Immune Globulin Infusion (Human) |
| Sponsor | Takeda |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Target | Fc receptors, complement system, pathogenic antibodies |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
As a 20% concentration immunoglobulin solution, it contains polyclonal IgG antibodies derived from pooled human plasma. It works by providing immediate passive immunity, neutralizing pathogens and toxins, blocking pathogenic autoantibodies, and modulating inflammatory immune responses through Fc receptor engagement and complement regulation. This makes it suitable for both immunodeficiency and autoimmune/inflammatory conditions.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency
- Autoimmune and inflammatory conditions (e.g., ITP, CIDP, myasthenia gravis)
Common side effects
- Headache
- Fever
- Chills
- Infusion reactions
- Thrombosis
- Renal dysfunction
Key clinical trials
- A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma (PHASE3)
- An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease (PHASE3)
- A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID) (PHASE3)
- A Study of TAK-881 in Healthy Adults (PHASE1)
- A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency (PHASE4)
- Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects (PHASE4)
- Phase 2/3 Study of IGSC, 20% in PIDD (PHASE2, PHASE3)
- Immune Globulin Subcutaenous (Human), 20% (PHASE2, 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 |