Kangyueda Stapokibart Injection

1. Indications and Usage
Atopic Dermatitis: Indicated for adult patients with moderate-to-severe atopic dermatitis whose disease has not adequately controlled with topical therapeutic agents or for whom those treatments are not appropriate.
Chronic Rhinosinusitis with Nasal Polyps: Indicated for the treatment of adult patients with chronic sinusitis with nasal polyps (CRSwNP) who are inadequately controlled with intranasal corticosteroids, glucocorticoid treatment, and/or surgery.
2. Dosage and Administration
Route of Administration: Subcutaneous injection ONLY.
Recommended Dosage (Atopic Dermatitis): The initial dose for adults is 600 mg (administered as two 300 mg injections). Subsequent maintenance doses are 300 mg administered once every two weeks.
Dosage (CRSwNP): The dosage for CRSwNP is 300 mg once every two weeks.
Critical Administration Instructions:
Site: Inject into the thigh or abdomen. Rotate injection sites with each dose.
Observation: Patients should be monitored for hypersensitivity reactions for at least 30 minutes after administration.
3. Mechanism of Action
IL-4Rα Antagonism: Stapokibart is a humanized monoclonal antibody (IgG4 type) that binds to the IL-4 receptor alpha subunit.
Signal Inhibition: It inhibits the signaling of both interleukin-4 (IL-4) and interleukin-13 (IL-13), key cytokines in the pathogenesis of atopic dermatitis and CRSwNP, thereby reducing inflammation and immune response.
4. Safety and Warnings
Hypersensitivity: Contraindicated in patients with severe hypersensitivity to stable proteins (Stapokibart) or any excipients. If an immediate-type or delayed systemic hypersensitivity reaction occurs, the drug should be discontinued immediately.
Ocular Events: Concomitant administration of Stapokibart may cause conjunctivitis and keratitis-related events. Patients should be monitored for eye irritation.
Parasitic Infections: Due to the inhibition of IL-4/IL-13 signaling, patients may be at increased risk of parasitic infections.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Conjunctivitis and injection site reactions.
Clinical Research Highlights: The safety profile is derived from six randomized, double-blind, placebo-controlled studies in adult patients with moderate-to-severe atopic dermatitis.
6. Drug Interactions
Vaccines: No formal human drug-drug interaction studies have been conducted. However, Stapokibart may impair the immune response to vaccines. Live or attenuated vaccines should generally be avoided during treatment.
Metabolic Enzymes: The mechanism of action and research data on similar products indicate no clinically relevant impact on the activity of CYP1A2, CYP3A, CYP2C19, CYP2D6, or CYP2C9.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Stapokibart. Excipients: Sodium acetate, glacial acetic acid, polysorbate 80, and water for injection.
Appearance: Clear to slightly opalescent, colorless to pale yellow solution.
Packaging: Single-dose pre-filled syringes or cartridges (e.g., 300 mg/2 mL).
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake. Protect from light.