Who is
QIVIGY®
for?

QIVIGY is for adult patients with primary immunodeficiency who expect quality outcomes backed by high treatment satisfaction, efficient infusion experiences, proven efficacy, and steady protection from infection.1-3

Expect more with QIVIGY

Paige

Paige


31 years of age

Living with CVID

Hypothetical patient.

Paige is the proud aunt of twin boys, Oliver and Nathan, and a data analyst for a small startup. She was diagnosed 5 years ago and has been dissatisfied with her current IVIG for some time. She experiences flu-like symptoms after each infusion and substantial drops in energy at the tail end of her dose interval, making it difficult to keep up with her nephews. Paige needs an IVIG she can tolerate that provides steady IgG levels month to month.

QIVIGY is Paige's choice because:

  • IgG trough levels had minimal fluctuations across both the 3- and 4-week dosing schedules2
  • QIVIGY was proven highly tolerable in clinical trials with zero AEs leading to discontinuation, zero significant, life-threatening TEAEs, and zero serious AEs2
Lucas

Lucas


22 years of age

Living with X-linked agammaglobulinemia

Hypothetical patient.

Lucas recently graduated from college and is starting his first full-time job as an events coordinator for a theater nonprofit. He is currently on an SCIG but still experiences breakthrough infections that require hospitalization from time to time. Lucas would like to switch to an IVIG that will deliver reliable protection with minimal adverse reactions and keep him out of the hospital.

QIVIGY is Lucas' choice because:

  • QIVIGY was proven effective in clinical trials with zero hospitalizations across 12 months of treatment1
  • ~97% of QIVIGY monthly infusions (623/643) were completed without rate reduction, interruption, or discontinuation2

There are no comparative head-to-head trials with QIVIGY.

Kelvin

Kelvin


67 years of age

Living with hypogammaglobulinemia

Hypothetical patient.

Kelvin is a retired law secretary and maintains a busy calendar as a volunteer city council member. He has a few comorbidities and limited dexterity that impairs his ability to self administer SCIG. Due to these considerations, his healthcare provider recommended he switch to an IVIG. Additionally, Kelvin is often on antibiotics for recurring bacterial infections, putting him at high risk for antibiotic resistance. He needs an IVIG that protects him from infection and reduces his dependence on antibiotics.

QIVIGY is Kelvin's choice because:

  • Patients treated with QIVIGY in the trial spent 3% of the year on antibiotics1*
  • QIVIGY was proven effective in clinical trials with zero acute serious bacterial infections (99% confidence limit: 0.10; n=47)1,2

*The median (min, max) duration of antibiotic treatment of any kind of infection was 10 days (1, 334). A total of 36 (76.6%) patients used at least 1 course of concomitant antibiotic therapy for treatment of infections. Eleven patients (23.4%) did not require antibiotic treatment.2

Acute serious bacterial infections include bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, visceral abscesses, or bacterial meningitis.1

AE, adverse event; AR, adverse reaction; CVID, common variable immune deficiency; IgG, immune globulin G; IVIG, intravenous immune globulin; SCIG, subcutaneous immune globulin; TEAE, treatment-related adverse event.

Patient support and resources

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. QIVIGY [prescribing information]. Kedrion Biopharma Inc.; 2025. 2. Data on file. REF-01262. Kedrion Biopharma Inc.; 2024. 3. Data on file. REF-01273. Kedrion Biopharma Inc.; 2025.