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RI-002
RI-002 is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering polyclonal human antibodies to boost immune function.
RI-002 is an intravenous immunoglobulin (IVIG) product that provides passive immunity by delivering polyclonal human antibodies to boost immune function. Used for Primary immunodeficiency disorders, Secondary immunodeficiency in hematologic malignancies.
At a glance
| Generic name | RI-002 |
|---|---|
| Also known as | Immune Globulin (Human) |
| Sponsor | ADMA Biologics, Inc. |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
RI-002 is derived from human plasma and contains a broad spectrum of immunoglobulins (primarily IgG) collected from multiple donors. It is administered intravenously to provide immediate passive immune protection and modulate immune responses in patients with immunodeficiency or certain autoimmune conditions. The polyclonal antibody preparation helps restore or enhance the patient's ability to fight infections and regulate inflammatory responses.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency in hematologic malignancies
Common side effects
- Headache
- Fever
- Chills
- Infusion site reactions
- Nausea
- Thrombotic events
Key clinical trials
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 |