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Flebogamma 5% DIF
Flebogamma 5% DIF is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to modulate immune responses and replace deficient immunoglobulins.
Flebogamma 5% DIF is an intravenous immunoglobulin (IVIG) preparation that provides passive immunity by supplying pooled human antibodies to modulate immune responses and replace deficient immunoglobulins. Used for Primary immunodeficiency disorders, Secondary immunodeficiency in hematologic malignancies, Idiopathic thrombocytopenic purpura (ITP).
At a glance
| Generic name | Flebogamma 5% DIF |
|---|---|
| Also known as | immune globulin intravenous (human) |
| Sponsor | Instituto Grifols, S.A. |
| Drug class | Intravenous immunoglobulin (IVIG) |
| Target | Fc receptors, pathogenic antigens and antibodies |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
As a human immunoglobulin G (IgG) product derived from pooled plasma of multiple donors, Flebogamma 5% DIF works through multiple mechanisms including antibody replacement in immunodeficiency states, immune modulation via Fc receptor engagement, and neutralization of pathogenic antibodies and antigens. The DIF (Diluent-Free) formulation allows for direct intravenous administration without requiring separate dilution.
Approved indications
- Primary immunodeficiency disorders
- Secondary immunodeficiency in hematologic malignancies
- Idiopathic thrombocytopenic purpura (ITP)
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Multifocal motor neuropathy (MMN)
- Post-transfusion purpura
- Kawasaki disease
Common side effects
- Headache
- Fever
- Chills
- Myalgia
- Fatigue
- Nausea
- Infusion site reactions
- Thrombosis
- Aseptic meningitis
Key clinical trials
- Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome (PHASE2, PHASE3)
- Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19) (PHASE2)
- A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease (PHASE2, PHASE3)
- Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects (PHASE4)
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:
- Flebogamma 5% DIF CI brief — competitive landscape report
- Flebogamma 5% DIF updates RSS · CI watch RSS
- Instituto Grifols, S.A. portfolio CI