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General Information
Yimmugo (immune globulin intravenous, human-dira) is an immune globulin intravenous, human - dira, 10% liquid.
Yimmugo is specifically indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age or older.
Yimmugo is supplied as a liquid for intravenous infusion. The recommended doses are below. The dosage may be adjusted over time to achieve the desired trough levels and clinical response.
Dose | Infusion Number | Initial Infusion Rate | Maintenance Infusion Rate (if tolerated) |
300–800 mg/kg (3–8 mL/kg) every 3–4 weeks | For the 1st 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). |
300–800 mg/kg (3–8 mL/kg) every 3–4 weeks | From the 2nd infusion | 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). |
Mechanism of Action
Yimmugo provides a broad spectrum of opsonizing and neutralizing immune globulin G (IgG) antibodies against a wide variety of pathogens and their toxins, which helps to avoid recurrent serious opportunistic infections. The mechanism of action has not been fully elucidated but may include immunomodulatory effects.
Side Effects
Adverse effects associated with the use of Yimmugo may include, but are not limited to, the following:
- headache
- upper respiratory tract infections
- fatigue
- nausea
- increased blood pressure
The Yimmugo drug label comes with the following Black Box Warning: Thrombosis may occur with immune globulin intravenous (IGIV) products, including Yimmug. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal 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
Clinical Trial Results
FDA approval of Yimmugo was based on data from an open-label, prospective, phase 3 study that evaluated the efficacy and safety of Yimmugo in 67 patients (mean age, 35 years) with PI who had established immune globulin intravenous therapy for at least 3 months with a constant dose, and at least one IgG trough level of at least 5g/L during the previous 3 months.
Study participants received Yimmugo 0.2 to 0.8g/kg body weight at either every 3 or 4 weeks for 12 months. The primary endpoint was the rate of serious bacterial infections (SBI), defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, visceral abscesses, or bacterial meningitis over a period of 12 months.
The acute SBI rate was reported to be 0.07 during the 12-month study period, which met the predefined success rate of less than 1 acute SBI per patient per year. Five patients experienced an acute SBI (all 5 episodes were bacterial pneumonia).