Introduction and marketing status of intravenous human immunoglobulin (Yimmugo)

1. Name: intravenous human immunoglobulin, immune globulin intravenous, human-dira

Product name:Yimmugo

2. Indications:

Intravenous human immunoglobulin (Yimmugo) is a 10% immunoglobulin liquid indicated for the treatment of primary humoral immunodeficiencies (PI), including but not limited to congenital agammaglobulinemia, common variant immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiency (SCID) in patients 2 years of age and older.

3. Usage and dosage:

1. Recommended dosage: The dosage and dosage regimen of intravenous human immunoglobulin depend on the indication. Dosage may need to be individualized for each patient based on clinical response. Underweight or overweight patients may require dosage adjustments based on body weight. The usual dose is 300-800 mg/kg (3-8 ml/kg) intravenously every 3-4 weeks.

2. Medication management: Before starting infusion, fully hydrate the patient; use Yimmugo at room temperature or body temperature through intravenous route. Do not mix with any IV medications. Monitor the patient's vital signs throughout the infusion. If adverse reactions occur, slow or stop the infusion. If symptoms resolve rapidly, the infusion can be continued at a lower rate that is comfortable for the patient. Ensure that patients with pre-existing renal insufficiency do not develop volume failure. For patients judged to be at risk for renal dysfunction or thrombotic events, administer Yimmugo at the lowest infusion rate feasible and consider discontinuing dosing if renal function worsens.

4. Adverse reactions:

In clinical studies of intravenous human immune globulin, common adverse reactions include headache, upper respiratory tract infection, fatigue, nausea, and increased blood pressure.

5. Supply and storage:

Intravenous human immunoglobulin Injection is available in 5, 10 and 20 gram single dose vials. Store in the original carton away from light. Refrigerate between 2°C and 8°C (36°F and 46°F). Do not use after expiration date. During the expiration date, the product may be stored at room temperature (above 8°C and not exceeding 25°C/above 46°F and not exceeding 77°F) for no more than 6 months. Once the product has been removed from the refrigerator, it must not be returned to the refrigerator. Please record the date of storage at room temperature on the product carton. Do not freeze. Do not use any solution that has been frozen.

6. Taboo:

1. Patients who are allergic to human immunoglobulin or have severe systemic reactions are prohibited from intravenous injection of human immunoglobulin;

2. IgA-deficient patients who have IgA antibodies and a history of allergies are prohibited from injecting human immune globulin intravenously.

7. Mechanism of action:

Intravenous human immunoglobulins provide broad-spectrum opsonizing and neutralizing immunoglobulinG (IgG) antibodies against a variety of pathogens and their toxins, helping to avoid recurring serious opportunistic infections. The mechanism of action has not been fully elucidated but may include immunomodulatory effects.

8. Listing situation:

Human immunoglobulin therapy first appearedin the 1930s, and the United States approved intravenous preparations for medical use in 1981;Yimmugo was approved by theU.S. Food and Drug Administration (FDA) in June 2024. There is no news of marketing approval of this drug in other regions.

References:https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/yimmugo