Qivigy FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 1, 2025.
FDA Approved: Yes (First approved September 26, 2025)
Brand name: Qivigy
Generic name: immune globulin intravenous, human-kthm
Dosage form: Solution for Infusion
Company: Kedrion Biopharma
Treatment for: Primary Immunodeficiency Syndrome
Qivigy (immune globulin intravenous, human-kthm) 10% solution is indicated for treatment of adults with primary humoral immunodeficiency (PI).
- Primary humoral immunodeficiency (PI) is a group of disorders characterized by an impaired ability to produce antibodies, which leads to an increased susceptibility to infection, especially bacterial infections affecting the respiratory and gastrointestinal tracts.
- Qivigy works to treat PI by boosting the immune system.
- Qivigy is administered by intravenous infusion every 3-4 weeks.
- Qivigy comes with a Boxed Warning for thrombosis, renal dysfunction, and acute renal failure. Warnings and precautions include hypersensitivity reactions; thrombotic events; hyperproteinemia, hyperviscosity, hyponatremia or pseudohyponatremia; renal injury; aseptic meningitis syndrome; hemolysis; transfusion-related acute lung injury (TRALI); and transmission of infectious agents.
- Common adverse reactions (observed in ≥ 5% of patients) include headache, fatigue, nausea, infusion-related reaction, Coombs direct test positive, sinusitis, dizziness and diarrhea.
Development timeline for Qivigy
| Date | Article |
|---|---|
| Sep 29, 2025 | Approval FDA Approves Qivigy (immune globulin intravenous, human-kthm) for Primary Humoral Immunodeficiency |
Further information
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