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Understanding the impact of primary immunodeficiency (PI) 

Hypothetical patient.

Patients with PI average 9 to 15 years from symptom onset to diagnosis, and experts estimate that >70% of individuals with PI remain undiagnosed.1 Patients with PI are subject to serious, prolonged, and sometimes life-threatening infections and autoimmunity when not properly identified and treated.2

The average annual cost of untreated PI is $124,404 per patient.2

Patients with PI still have frequent life-interrupting events despite treatment2*

FOLLOWING DIAGNOSIS, PATIENTS TREATED FOR PI EXPERIENCE ON AVERAGE2*:

3.1Days Hospitalizeddue to infection per year
11.7Emergency Room Visitsper year
~20%of the yearon antibiotics
Average of9 Days Lostfrom work/school2
It's time toEXPECT MOREfrom PI treatment.

*A total of 300 Jeffrey Modell Foundation physician surveys from 681 physicians were included in this analysis, representing 80 countries, 227 cities, and 280 institutions. Physician-reported data from 2021 on select outcomes of their adult and pediatric patients with PI 1 year prior to and 1 year following diagnosis were compared with data from 2018 and 2013. Patients were treated with IgRT following diagnosis.2

IgRT, immune globulin replacement therapy.

See the clinical results of QIVIGY®
Important Safety Information

INDICATIONS AND USAGE

QIVIGY® (immune globulin intravenous, human-kthm) is a 10% immune globulin (Ig) liquid indicated for the treatment of adults with primary humoral immunodeficiency.

Important safety information

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

See full prescribing information for complete boxed warning.

  • Thrombosis may occur with immune globulin products, including QIVIGY.
  • Renal dysfunction, acute renal failure, osmotic nephrosis may occur with immune globulin intravenous (IGIV) products in predisposed patients. Such events require immediate medical intervention, if not recognized or managed appropriately, may result in persistent or significant disability or incapacity or lead to fatal outcome.
  • For patients at risk of thrombosis, renal dysfunction or failure, administer QIVIGY at the minimum dose available and the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

CONTRAINDICATIONS

QIVIGY is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA deficient patients with antibodies against IgA and history of hypersensitivity.

WARNINGS AND PRECAUTIONS

Severe hypersensitivity reactions, including anaphylaxis, may occur. In case of hypersensitivity, discontinue QIVIGY infusion and manage as appropriate.

Hyperproteinemia, hyperviscosity, and hyponatremia may occur in patients receiving IGIV treatment, including QIVIGY.

Aseptic meningitis syndrome may occur in patients receiving IGIV treatment, especially with high doses or rapid infusion.

Hemolysis can develop subsequent to IGIV treatment. Monitor patients for hemolysis.

Transfusion-related acute lung injury: Monitor patients for pulmonary adverse reactions.

Transmissible infectious agents: QIVIGY is made from human plasma and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Interference with laboratory tests: After infusion of Ig, transitory rise of passively transferred antibodies may yield positive serological results, with potential for misleading interpretation.

ADVERSE REACTIONS

The most common adverse reactions occurring in ≥5% of patients treated were headache, fatigue, infusion-related reaction, Coombs direct test positive, nausea, sinusitis, dizziness, and diarrhea.

To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. at 1-855-3KDRION (1-855-353-7466) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for complete prescribing details, including Boxed Warning.

References: 1. Immune Deficiency Foundation. Diagnosing primary immunodeficiency. Accessed February 24, 2026. https://primaryimmune.org/advancing-pi-research-and-clinical-care/diagnosing-pi 2. Quinn J, Modell V, Orange JS, Modell F. Growth in diagnosis and treatment of primary immunodeficiency within the global Jeffrey Modell Centers Network. Allergy Asthma Clin Immunol. 2022;18(1):19.