Clinical Results

Proven protection against serious bacterial infections1

The primary endpoint for YIMMUGO® in a phase 3 pivotal trial was to demonstrate an acute SBI rate of <1.0 per person-year. Additional outcome measures included occurrence of any infection, number of days missed from work/school, and hospitalizations.1,2

Primary Endpoint1
0.07
acute SBIs per person-year 
(99% CI: 0.21; N=67) 

Fewer missed days and hospitalizations than average1,3

ADDITIONAL STUDY OUTCOMES IMPORTANT TO PATIENTS WITH PI1
  • Backpack icon
    6 days
    lost from work/school due to infection*
  • Hospital icon
    <1/2 a day
    of hospitalization due to infection per person-year
  • Infection icon
    2.7
    other infections per person-year

THE YIMMUGO DIFFERENCE

YIMMUGO was well tolerated in pediatric, adult, and geriatric patients with no clinically relevant differences between age groups.4

STUDY DESIGN

YIMMUGO was studied in an open-label, prospective, multicenter, multinational trial. The efficacy, safety, and pharmacokinetic properties of YIMMUGO as replacement therapy in patients with PI were investigated in 67 patients (including 12 children and 6 adolescents).1

Patients received a dose between 200 mg/kg and 800 mg/kg of body weight every 3-4 weeks for a treatment period of 12 months. The study enrolled patients with PI who were aged 2-75 years and who had established IVIG therapy for ≥3 months with a constant dose, and at least 1 IgG trough level ≥5 g/L during previous 3 months.1

Demonstrated safety and tolerability with a low rate of headache1

Only 2% of infusions were associated with headache1

ARs IN ≥5% OF PATIENTS1†
Adverse reaction
(AR)
INFUSIONS, Ninf=923
% (n)
Headache 2% (22)
Upper respiratory infections <1% (8)
Fatigue <1% (8)
Nausea <1% (5)
Increased blood pressure <1% (4)
  • Overall, only 10% of infusions (93/923) were associated with an AR1
  • There were 2 SAEs related to YIMMUGO occurring in 2 patients: anaphylactic reaction and severe neutropenia. Both SAEs led to discontinuation of YIMMUGO1
  • One patient also had mild hemolysis and a positive Coombs test1

THE YIMMUGO DIFFERENCE

No pediatric patients and only 1 adult patient treated with YIMMUGO required premedication.2,4‡
*
Number of days presented as median among patients with events of a duration of ≥1 day.1
†
ARs were identified as all adverse events that were temporally associated with an infusion (occurred during infusion or within 72 hours after the end of an infusion) or that were assessed as related.1
‡
A single premedication was given at the first infusion due to a history of infusion-related reactions. No additional premedication was required throughout the study.4
IgG, immune globulin G; IVIG, intravenous immune globulin; PI, primary immunodeficiency; SAE, serious adverse event; SBI, serious bacterial infection.

INDICATIONS AND USAGE

YIMMUGO® (immune globulin intravenous, human – dira) is a 10% immune globulin (Ig) liquid indicated for the treatment of primary humoral immunodeficiency in patients 2 years of age and older.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

  • Thrombosis may occur with Ig intravenous (IGIV) products, including YIMMUGO.
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and failure occur more commonly in patients receiving IGIV products containing sucrose. YIMMUGO does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction, or renal failure, administer YIMMUGO at the minimum dose and 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

YIMMUGO is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human Ig and in patients with immunoglobulin A (IgA) deficiency who have antibodies against IgA and a history of hypersensitivity.

WARNINGS AND PRECAUTIONS

Severe hypersensitivity reactions, including anaphylaxis, have been reported after administration. In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. YIMMUGO contains ≤300 mcg/mL of IgA. Patients with known antibodies to IgA may be at greater risk.

Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to IGIV treatment. Risk factors for hemolysis include high doses and non-O blood group. Monitor patients for hemolysis.

Renal failure: Monitor renal function, including blood urea nitrogen (BUN) and serum creatinine, and urine output in patients at risk of developing acute renal failure.

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV treatment, including YIMMUGO.

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

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

Transmissible infectious agents: YIMMUGO is made from human plasma and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

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

ADVERSE REACTIONS

The most common adverse reactions occurring in ≥5% of patients were headache, upper respiratory tract infections, fatigue, nausea, and increased blood pressure.

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. Kriván G, Borte M, Soler-Palacin P, et al. BT595, a 10% human normal immunoglobulin, for replacement therapy of primary immunodeficiency disease: results of a subcohort analysis in children. J Clin Immunol. 2023;43(3):557-567. 3. 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. 4. Kriván G, Borte M, Harris JB, et al. Efficacy, safety and pharmacokinetics of a new 10% normal human immunoglobulin for intravenous infusion, BT595, in children and adults with primary immunodeficiency disease. Vox Sang. 2022;117(10):1153-1162.
IMPORTANT SAFETY INFORMATION

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