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IV treatment with IGSC, 10%
IGSC 10% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to help regulate immune function and fight infections.
IGSC 10% is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to help regulate immune function and fight infections. Used for Primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, common variable immunodeficiency), Secondary immunodeficiencies, Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy).
At a glance
| Generic name | IV treatment with IGSC, 10% |
|---|---|
| Also known as | GAMMAGARD LIQUID (US), KIOVIG (EU) |
| Sponsor | Baxalta now part of Shire |
| Drug class | Immunoglobulin replacement therapy |
| Target | Fc receptors, complement system, pathogenic antigens |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
This product contains immunoglobulin G (IgG) antibodies derived from pooled human plasma, administered intravenously at 10% concentration. It works by providing immediate passive immunity, neutralizing pathogens, and modulating immune responses through Fc receptor engagement and complement activation. It is used to treat primary immunodeficiencies and certain secondary immune conditions.
Approved indications
- Primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, common variable immunodeficiency)
- Secondary immunodeficiencies
- Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy)
Common side effects
- Headache
- Fever
- Chills
- Fatigue
- Infusion reactions
- Thrombosis (rare)
Key clinical trials
- Phase 2/3 Study of IGSC, 20% in PIDD (PHASE2, PHASE3)
- Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID (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:
- IV treatment with IGSC, 10% CI brief — competitive landscape report
- IV treatment with IGSC, 10% updates RSS · CI watch RSS
- Baxalta now part of Shire portfolio CI