Starting YIMMUGO®

Dosing and administration

Well-tolerated dosing and infusion rate escalation1

RECOMMENDED DOSAGE1,2

Dose
300-800 mg/kg
(3-8 mL/kg)
every 3-4 weeks
Maximum
infusion rate:
8 mL/kg/h

First Infusion

0.5 mg/kg/min (0.005 mL/kg/min) for 30 minutes; gradually increase every 30 minutes up to 3.0 mg/kg/min (0.03 mL/kg/min)

Subsequent Infusions

0.5 mg/kg/min (0.005 mL/kg/min) for 30 minutes; gradually increase up to 13 mg/kg/min (0.13 mL/kg/min)

YIMMUGO delivers reliable infusions without compromising tolerability1

  • No infusion-related adverse events above 4.0 mL/kg/h1
  • Average infusion time decreased by 52 minutes and 71 minutes as the infusion rate increased1*
  • The majority of infusions were completed without interruption or infusion rate reduction1
    • 4 patients (6%) modified or interrupted 4 infusions (0.43%) due to TEAEs 

THE YIMMUGO DIFFERENCE

A maximum infusion rate of up to 8 mL/kg/h was well tolerated across all age groups.1,3

YIMMUGO® Dosing Calculator for Primary Immunodeficiencies (PI)

Select the type of infusion you want to calculate:

For patients 2 years of age and older, the dose of YIMMUGO for the treatment of PI is 300–800 mg/kg (3–8 mL/kg) every 3–4 weeks
mg/kg
Results
Weight: 70 kg
Total
Dose 		Total Infusion
Volume
Initial Infusion Rate
0.5 mg/kg/min
(0.005 mL/kg/min)
Maximum Infusion Rate
3.0 mg/kg/min
(0.03 mL/kg/min)
g mL
mg/min or
mL/min
mg/min or
mL/min
Estimated time to infuse total infusion volume at initial infusion rate: .
Estimated time to infuse total infusion volume at maximum infusion rate: .
For patients 2 years of age and older, the dose of YIMMUGO for the treatment of PI is 300–800 mg/kg (3–8 mL/kg) every 3–4 weeks
mg/kg
Results
Weight: 70 kg
Total
Dose 		Total Infusion
Volume
Initial Infusion Rate
0.5 mg/kg/min
(0.005 mL/kg/min)
Maximum Infusion Rate
13.0 mg/kg/min
(0.13 mL/kg/min)
g mL
mg/min or
mL/min
mg/min or
mL/min
Estimated time to infuse total infusion volume at initial infusion rate: .
Estimated time to infuse total infusion volume at maximum infusion rate: .

Ordering YIMMUGO

YIMMUGO is made to fit your patient’s needs2

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YIMMUGO is glycine stabilized and does not contain any sugars or preservatives2
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YIMMUGO is supplied in 5-, 10-, and 20-gram single-dose vials and has a 30-month shelf life when stored at 5 °C/41 °F ± 3 °C/37.4 °F2,4
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Within the expiration date, YIMMUGO may be stored at room temperature (more than 8 °C and up to 25 °C/more than 46 °F and up to 77 °F) for a single period not exceeding 6 months2

THE YIMMUGO DIFFERENCE

YIMMUGO is available in 3 vial sizes for dosing flexibility2
YIMMUGO 5 g in 50 mL vial and box
YIMMUGO 10 g in 100 mL vial and box
YIMMUGO 20 g in 200 mL vial and box

YIMMUGO is available through the following specialty pharmacies:

  • *Of the 67 patients studied in the clinical trial, 12 patients received YIMMUGO on a Q3W schedule and 55 patients on a Q4W schedule. The Q3W schedule group experienced decreased infusion times from a median of 174 minutes (infusion 1) to 122 minutes (last protocol-defined infusion) and from a median of 165 minutes to 94 minutes in the Q4W schedule group.1
  • Q3W, every 3 weeks; Q4W, every 4 weeks; TEAE, treatment-emergent adverse event.

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Medical Information

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US_MedicalInfo@kedrion.com
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General Information

For more information, call 1-866-398-0825 or email
US_CustomerService@kedrion.com

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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. 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. 2. YIMMUGO [prescribing information]. Kedrion Biopharma Inc.; 2024. 3. 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. 4. Data on file. Kedrion Biopharma Inc.; 2025.

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You may also call Kedrion Biopharma toll free at 1-855-353-7466 for customer service assistance.
IMPORTANT SAFETY INFORMATION

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