Exdensur (depemokimab-ulaa) instruction manual in Chinese

1. Common names:Exdensur, depemokimab-ulaa

2. Indications:

Exdensur (depemokimab-ulaa) is indicated for use in adults and pediatric patients 12 years of age and older for the adjunctive maintenance treatment of severe asthmawith eosinophil-related features.

Restrictions on Use:EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus.

3. Usage and dosage:

1. Recommended dose: Exdensur is only for subcutaneous injection. The recommended dose is 100 mg once every 6 months. Inject into the upper arm, thigh or abdomen through subcutaneous injection (SC), avoiding 2 inches (5cm) around the belly button.

2. Missed dose: If a dose of medication is missed, the missed dose should be taken as soon as possible and the injection schedule every 6 months should be resumed from the date of the missed dose.

3. Select the injection site: Exdensur can only be injected into the upper arm, thigh or abdomen, avoiding 2 inches (5cm) around the belly button. Do not inject if the skin is tender, bruised, red, or hard.

4. Adverse reactions:

In clinical studies of Exdensur, common adverse reactions (incidence ≥4%) include upper respiratory tract infection, allergic rhinitis, influenza, joint pain and pharyngitis; warnings and precautions related to Exdensur include allergic reactions, acute asthma symptoms or exacerbation, risks related to sudden reduction of corticosteroid dose, parasitic (worm) infection, etc.

5. Supply and storage:

1. Supply: Exdensur injection is a sterile, preservative-free, colorless, yellow to brown, clear to milky white subcutaneous (SC) injection. Prefilled pens and prefilled syringes are not made from natural rubber. Exdensur injection is available in 100 mg/ml.

2. Storage: Store refrigerated in original carton at 36°F to 46°F (2°C to 8°C) to avoid light. Do not freeze. Don't shake. Avoid exposure to high temperatures. Prefilled pens and prefilled syringes can be removed from the refrigerator and stored in unopened cartons in the dark at room temperature up to 86°F (30°C) for 7 days. If left out of the refrigerator for more than 7 days, discard. Prefilled pens or prefilled syringes must be used within 8 hours of removal from the carton. If not taken within 8 hours, discard.

6. Mechanism of action:

depemokimab-ulaa is an IL-5 antagonist (humanized IgG1 monoclonal antibody) that binds IL-5 with a dissociation constant of 10.5 pM and inhibits the biological activity of IL-5 with an in vitro IC50 value of 4 pM by blocking its binding to the α chain of the IL-5 receptor complex expressed on the cell surface. depemokimab-ulaa contains a three-amino acid substitution (YTE) in the fragment crystallizable (Fc) region, which increases binding to nascent Fc receptors, thereby extending elimination half-life. These properties support dosing every 6 months.

IL-5 is the primary cytokine responsible for eosinophil growth and differentiation, recruitment, activation, and survival. Inflammation is an important component in the pathogenesis of asthma. Multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (eg, histamines, eicosanoids, leukotrienes, cytokines) are involved in inflammation. By inhibiting IL-5 signaling, depemokimab-ulaa reduces eosinophil production and survival; however, depemokimab's mechanism of action in asthma has not been clearly established.

7. Listing situation:

United States:December 16, 2025, product name: Exdensur;

China: Not yet available.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=30332b20-2ac0-42ad-a775-d3ca7f5fe29f