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What is QIVIGY®?

Hypothetical patient.

QIVIGY (KEE'-vi-jee) is a type of FDA-approved immune globulin replacement therapy (IgRT) administered intravenously for adults with primary immunodeficiency (PI) called that replaces that are missing or do not work as they should. The goal of this treatment is to reduce the number, severity, and potential complications of repeated infections in people with PI.1

QIVIGY was studied in a to measure its safety and effectiveness in adults with PI.1

The QIVIGY clinical trial1

Length of trial
12 months
Treatment given every 3 or 4 weeks
Number of participants
47 people
aged 20 to 70 years
Main Measure of Effectiveness
<1
per person per year

How did QIVIGY perform in its clinical trial?

People receiving QIVIGY experienced on average:

0
ZERO Acute serious bacterial infections
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per person per year1,2

0
ZERO days in the hospital due to infection
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per person per year1

The trial also looked at the impact of infections on daily life in people treated with QIVIGY1

infection icon

2.1

other infections

per person per year1

pill icon

3%

of the year on antibiotics1*

work/school icon

6 days

lost from work/school

due to infection

per person per year (median)1†

Expect the quality protection you deserve.

*The median duration of antibiotic use during the 1-year trial was 10 days. Thirty-six people in the trial used at least 1 antibiotic while taking QIVIGY. Eleven people in the trial did not need antibiotics.2

†The range of missed days from work/school due to infection was 1-53 days.1

What are the potential side effects of QIVIGY?

The safety of QIVIGY was studied in a 12-month clinical trial, with the most common side effects listed below. Be sure to tell your doctor about any side effects you may experience with QIVIGY.1

The most common side effects of QIVIGY seen in less than 5% of infusions were1:

  • Headache
  • Fatigue
  • Nausea
  • Infusion-related reaction
  • Positive
  • Sinusitis
  • Dizziness
  • Diarrhea

No one in the clinical trial experienced side effects attributed to QIVIGY that were considered serious, life-threatening, or left them unable to complete the trial.2

Adult at home during an infusion
Hypothetical patient.

93%of people in the trial reported satisfaction with QIVIGY

vs 68% who reported satisfaction with their previous IVIG therapy.2†

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*A positive Coombs test indicates the presence of antibodies that may harm red blood cells. No harm to red blood cells were reported during the trial and no laboratory findings that would suggest harm to red blood cells associated with a positive test result were found.3

†Based on a study-specific patient satisfaction questionnaire. This questionnaire was an exploratory endpoint in the trial meant to give more insight about QIVIGY beyond the main goals of the trial. All 47 people in the trial completed the questionnaire at Week 24.2

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Important Safety Information

What is QIVIGY®?

QIVIGY (immune globulin intravenous, human-kthm) is an immune globulin (Ig) liquid used to treat adults with primary humoral immunodeficiency.

Important safety information

QIVIGY may cause:

  • Blood clots (thrombosis). Blood clots may occur in people taking Ig intravenous (IGIV) products, including QIVIGY. You may be at greater risk for blood clots if you are older, sit or lie for long periods, have a clotting problem or history of blood clots, take estrogen, have a central catheter, have thick blood, and/or if you have other conditions that put you at risk for cardiovascular disease. Blood clots may occur even if you do not have any of these risk factors. Your healthcare provider will monitor you for signs and symptoms of blood clotting.
  • Impaired kidney function or kidney failure. IGIV products have been associated with kidney dysfunction and damage, kidney failure, and death. You may be at greater risk for kidney failure if you have kidney disease, diabetes, are over 65, are seriously dehydrated, overweight, have certain infections like sepsis, have a condition that causes abnormal proteins in your blood, or take drugs that may damage your kidneys. Your healthcare provider will monitor your kidney function before and periodically after your first infusion.

Do NOT use QIVIGY if:

  • You have a history of severe hypersensitivity or a history of allergic reactions to human Ig. Tell your healthcare provider if you have had a serious reaction to other medicines that contain human Ig or ask if you are not sure.
  • You have an immunoglobulin A (IgA) deficiency, have antibodies to IgA, and have a hypersensitivity or a history of allergic reactions. Tell your healthcare provider if you have an IgA deficiency or ask if you are not sure.

WARNINGS AND PRECAUTIONS

  • Severe allergic reactions may occur. People with IgA deficiency who have antibodies against IgA may be at greater risk of these reactions.
  • You could experience higher-than-normal levels of protein in your blood, thick blood, or low sodium (salt) in your blood. This may prevent your blood from flowing easily and possibly lead to blood clots.
  • Brain swelling called aseptic meningitis syndrome may occur with IGIV products, especially if you receive a high dose or a rapid infusion.
  • Blood damage called hemolysis and hemolytic anemia can develop after treatment with QIVIGY. Your healthcare provider will monitor you for signs and symptoms.
  • Swelling of the lungs may occur following treatment. Your healthcare provider will monitor you for signs of lung damage.
  • QIVIGY is made from human blood and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
  • Be sure to tell your healthcare provider about your recent history of vaccinations. Live vaccines for diseases like measles, mumps, rubella, and varicella may not work as well while receiving QIVIGY. Tell your healthcare provider that you are taking QIVIGY before you receive any vaccination.

ADVERSE REACTIONS

The most common side effects of QIVIGY were headache, fatigue, infusion-related reaction, positive direct Coombs test result suggesting the immune system is attacking the body's red blood cells, nausea, sinus inflammation, dizziness, and diarrhea. During treatment with QIVIGY, be sure to tell your healthcare provider about any unusual symptoms you experience, as they may indicate a possible side effect.

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. Cleveland Clinic. Coombs test. Content last reviewed on May 11, 2022. Accessed March 10, 2025. https://my.clevelandclinic.org/health/diagnostics/22978-coombs-test