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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.
IMPORTANT SAFETY INFORMATION

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