Yimmugo FDA Approval History
Last updated by Judith Stewart, BPharm on June 18, 2024.
FDA Approved: Yes (First approved June 13, 2024)
Brand name: Yimmugo
Generic name: immune globulin intravenous, human-dira
Dosage form: Liquid for Intravenous Injection
Company: Grifols USA, LLC
Treatment for: Primary Immunodeficiency Syndrome
Yimmugo (immune globulin intravenous, human-dira) is an immune globulin liquid for intravenous injection indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age or older.
- 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. Yimmugo works to treat PI by boosting the immune system.
- Yimmugo is a polyvalent immunoglobulin G preparation for intravenous administration (IVIg). It is made from human blood and may contain infectious agents such as viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
- Yimmugo is administered by intravenous infusion every 3-4 weeks.
- Yimmugo comes with a Boxed Warning for thrombosis, renal dysfunction, and acute renal failure. Warnings and precautions include hypersensitivity and anaphylactic reactions; hemolysis; hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia; aseptic meningitis syndrome.
- Common adverse reactions include headache, upper respiratory tract infections, fatigue, nausea and increased blood pressure.
Development timeline for Yimmugo
| Date | Article |
|---|---|
| Jun 17, 2024 | Approval FDA Approves Yimmugo (immune globulin intravenous, human-dira) to Treat Primary Immunodeficiencies |
Further information
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