What Is
Yimmugo®
and How
Can It Help?

YIMMUGO (imm • YOO • go) is an FDA-approved IVIG An infusion treatment created from donated antibodies to manage immunodeficiency disorders used to treat patients with primary immunodeficiency (PI). YIMMUGO was studied in a clinical trial A research study that evaluates new interventions, like tests or treatments, and their effect on a person’s health  to see how safe and effective it was for children and adults with PI. The clinical trial lasted for approximately 1 year and included 67 people aged 2 to 75 years.1

The trial evaluated how many serious bacterial infections (SBIs) Infections considered to be serious over 12 months in the YIMMUGO clinical trial, including bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, visceral abscesses, or bacterial meningitis1 people across all age groups had in 1 year when treated with YIMMUGO.1

How effective is YIMMUGO?

Patients receiving YIMMUGO experienced on average1:

Infection icon
0.07
SBIs per person per year across all age groups
In a clinical trial, people treated with YIMMUGO had less than 1 SBI per year on average, no matter their age.1

Less downtime was seen with YIMMUGO1*

The study also looked at the impact of infections on daily life1:

  • Backpack icon
    6 days
    lost from work/school due to infection
  • Hospital icon
    <1/2 a day
    in the hospital due to infection per person per year
  • Infection icon
    2.7
    other infections per person per year
Proven protection when you need it most

What are the potential side effects with YIMMUGO? 

The safety of YIMMUGO was studied in a total of 923 infusions in a clinical trial, and the results showed that most side effects were considered mild to moderate.1

Headache icon
Only
2%
of infusions were associated with headaches.1

Headaches were the most common side effect for people taking YIMMUGO.1

Other common side effects that were seen in less than 1% of infusions included1:

  • Upper respiratory tract infections
  • Fatigue
  • Nausea
  • Increased blood pressure

There were 2 serious side effects related to YIMMUGO occurring in 2 patients.1†

Talk to your doctor if you have any questions regarding the safety of YIMMUGO or if you experience any side effects after an infusion.
*
On average, people living with PI missed about 34 days of school each year and spent nearly 20 days in the hospital. These findings came from doctors who cared for 119 patients participating in a special genetic testing program across 21 medical centers.2
†
One patient experienced prophylactic reaction and 1 patient experienced severe neutropenia. Both were serious side effects that led to ending treatment with YIMMUGO.1
IVIG, intravenous immune globulin.
See how YIMMUGO worked for children

What is YIMMUGO®?

YIMMUGO (immune globulin intravenous, human – dira) is an immune globulin (Ig) liquid used to treat primary humoral immunodeficiency in people 2 years of age and older.

IMPORTANT SAFETY INFORMATION

YIMMUGO may cause:

  • Blood clots (thrombosis). Blood clots may occur in people taking Ig intravenous (IGIV) products, including YIMMUGO. You may be at greater risk for blood clots if you are older, sit or lie for long periods, have a clotting condition or a 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 should monitor you for signs and symptoms of blood clotting.
  • Impaired kidney function or kidney failure. IGIV products, particularly those that contain sugar (sucrose), have been associated with kidney dysfunction and damage, kidney failure, and death. Kidney damage and failure are more common in people receiving IGIV products containing sucrose. YIMMUGO does not contain sucrose. You may be at greater risk for kidney failure if you have kidney disease, diabetes, are seriously dehydrated, overweight, take drugs that may damage your kidneys, or are over age 65. Your healthcare provider should monitor your kidney function before and periodically after your first infusion.

Do NOT use YIMMUGO 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, or 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.
  • Blood damage called hemolysis and hemolytic anemia can develop after treatment with YIMMUGO. Your healthcare provider should monitor you for signs and symptoms.
  • If you are at risk of developing kidney damage or failure, your healthcare provider should monitor your kidney function before and periodically after your first infusion.
  • 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 infrequently with IGIV products, especially if you receive a high dose or a rapid infusion.
  • Swelling of the lungs may occur following treatment. Your healthcare provider should monitor you for signs of lung damage. 
  • YIMMUGO 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 YIMMUGO. Tell your healthcare provider that you are taking YIMMUGO before you receive any vaccination.

ADVERSE REACTIONS

The most common side effects of YIMMUGO were headache, upper respiratory tract infections, fatigue, nausea, and increased blood pressure. During treatment with YIMMUGO, 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. YIMMUGO [prescribing information]. Kedrion Biopharma Inc.; 2024. 2. Quinn J, Modell V, Holle J, et al. Jeffrey’s insights: Jeffrey Modell Foundation’s global genetic sequencing pilot program to identify specific primary immunodeficiency defects to optimize disease management and treatment. Immunol Res. 2020;68(3):126-134.
IMPORTANT SAFETY INFORMATION

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