Last reviewed · How we verify
CUVITRU
At a glance
| Generic name | CUVITRU |
|---|---|
| Also known as | 20% Solution, IGSC, Immune Globulin Subcutaneous (Human), IGSC 20%, IGI 20% |
| Sponsor | Baxalta now part of Shire |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
Common side effects
- Local adverse reactions
- Headache
- Nausea
- Fatigue
- Diarrhea
- Vomiting
- Systemic adverse reactions
Serious adverse events
- No serious adverse reactions reported
Key clinical trials
- Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia (PHASE2)
- A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
- IVIG vs SCIG in CIDP (PHASE1)
- A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (PHASE3)
- Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS (PHASE3)
- At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill
- Subcutaneous Immunoglobulin for Myasthenia Gravis (PHASE2)
- Usage of Spirometry in Managing IgG Therapy in CVID with Airway Disease (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:
- CUVITRU CI brief — competitive landscape report
- CUVITRU updates RSS · CI watch RSS
- Baxalta now part of Shire portfolio CI