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Gammaplex (5%)
Gammaplex is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by delivering pooled human antibodies to boost immune function.
Gammaplex is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by delivering pooled human antibodies to boost immune function. Used for Primary immunodeficiency disorders, Secondary immunodeficiency (e.g., chronic lymphocytic leukemia, HIV), Idiopathic thrombocytopenic purpura (ITP).
At a glance
| Generic name | Gammaplex (5%) |
|---|---|
| Sponsor | Bio Products Laboratory |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Target | Fc receptors and complement system (indirect mechanism via antibody delivery) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Gammaplex contains immunoglobulin G (IgG) antibodies derived from pooled human plasma, which are administered intravenously to patients with primary or secondary immunodeficiencies. The antibodies provide immediate passive immunity, helping to prevent or treat infections and modulate immune responses in conditions where antibody production is deficient or dysfunctional.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency (e.g., chronic lymphocytic leukemia, HIV)
- Idiopathic thrombocytopenic purpura (ITP)
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Multifocal motor neuropathy
Common side effects
- Headache
- Fever
- Chills
- Fatigue
- Myalgia
- Infusion reactions
- Thrombosis (rare)
Key clinical trials
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study (PHASE4)
- Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome (PHASE2)
- Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904) (PHASE2)
- Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2 (PHASE2)
- TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies (PHASE2)
- Add-on Intravenous Immunoglobulins in Early Myositis (PHASE2, PHASE3)
- Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis (PHASE2)
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 |