Caprylic Acid Treatment
reduces viruses and eliminates thrombogenic factors such as FXIa and others1,2
About YIMMUGO®
WHAT IS YIMMUGO?
YIMMUGO is a highly purified, 10% IVIG that delivers what patients with PI need the most1:
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Protection
Proven efficacy against serious bacterial infections and other infections1 -
HIGH TOLERABILITY
Demonstrated safety and infusion tolerability with a low rate of headache1 -
PRECISION
Patented manufacturing process designed to preserve functional antibodies and remove specific impurities believed to cause side effects2*
How YIMMUGO IS MADE
Patented manufacturing process designed to preserve antibodies and remove specific impurities2
VIBROMIX technology gently mixes a solution containing immunoglobulins by vibration, which may help minimize aggregate formation and reduce unwanted immune responses.2*
YIMMUGO is manufactured in a state-of-the-art plasma fractionation facility designed for efficiency and sustainability. Responsible use of plasma supports access to this life-saving therapy for patients with PI, both present and future.3
THE YIMMUGO DIFFERENCE
YIMMUGO is the only IVIG that uses VIBROMIX technology in combination with caprylic acid treatment, which is designed to preserve functional antibodies and reduce the formation of unwanted aggregates.2
Strategic optimizations reduce or minimize protein contaminations that may be associated with side effects2:
-
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Anion Exchange Chromatography
reduces viruses and IgA1,2
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Cation Exchange Chromatography
removes properdin for very low anticomplementary activity levels1,2†
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Nanofiltration
for greater virus reduction1,2
THE YIMMUGO DIFFERENCE
The innovative manufacturing process of YIMMUGO improves purity and includes several steps to increase the margins of safety through virus removal/inactivation.1,2
*
There have been no head-to-head comparisons between YIMMUGO and other IVIG products. No comparisons between conventional mixing techniques and vibromixing have been conducted.2
†
Properdin is an activator protein of the alternative pathway of the complement cascade and enhances ACA levels, thus influencing tolerability and safety of IVIG products. This protein is removed from the preparation by cation exchange chromatography during the manufacturing process of YIMMUGO.2
ACA, anticomplementary activity; FXIa, activated coagulation factor XI; IgA, immune globulin A; IVIG, intravenous immune globulin; PI, primary immunodeficiency.
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. Duellberg C, Hannappel A, Kistner S, Maneg O. Biochemical characterization of a new 10% IVIG preparation [IgG Next Generation (BT595)/Yimmugo®] obtained from a manufacturing process preserving IgA/IgM potential of human plasma. Drugs R D. 2023;23(3):245-255. 3. Data on file. Biotest AG; 2025.