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Kedrion IVIG 10%
Kedrion IVIG 10% is an intravenous immunoglobulin preparation that provides passive immunity by supplying pooled human antibodies to modulate immune responses and neutralize pathogens.
Kedrion IVIG 10% is an intravenous immunoglobulin preparation that provides passive immunity by supplying pooled human antibodies to modulate immune responses and neutralize pathogens. Used for Primary immunodeficiency disorders, Secondary immunodeficiency (e.g., in hematologic malignancies), Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy).
At a glance
| Generic name | Kedrion IVIG 10% |
|---|---|
| Also known as | KIg 10 |
| Sponsor | Kedrion S.p.A. |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Target | Multiple (polyvalent IgG; Fc receptors; complement system) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
IVIG contains polyvalent immunoglobulins (primarily IgG) derived from pooled human plasma that can bind to pathogens, opsonize antigens, and activate complement. It also modulates autoimmune and inflammatory responses through Fc receptor engagement, anti-idiotypic antibody interactions, and immune tolerance mechanisms. The 10% concentration indicates a higher protein concentration suitable for intravenous administration.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency (e.g., in hematologic malignancies)
- Autoimmune and inflammatory conditions (e.g., immune thrombocytopenia, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy)
Common side effects
- Headache
- Fever
- Chills
- Myalgia
- Infusion reactions
- Thrombosis
- Aseptic meningitis
Key clinical trials
- A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP) (PHASE3)
- A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (PHASE3)
- Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10) (PHASE3)
- Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients (PHASE3)
- Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (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:
- Kedrion IVIG 10% CI brief — competitive landscape report
- Kedrion IVIG 10% updates RSS · CI watch RSS
- Kedrion S.p.A. portfolio CI