Jinlixi Xeligekimab Injection

1. Indications and Usage
Plaque Psoriasis: Indicated for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
2. Dosage and Administration
Route of Administration: Subcutaneous injection ONLY.
Recommended Dosage: The recommended dose is 200 mg (administered as two 100 mg injections) at Week 0, 2, 4, 6, 8, 10, and 12, followed by 200 mg every 4 weeks thereafter.
Critical Administration Instructions:
Site: Avoid injecting into psoriatic lesions. Injection sites may include the thigh, abdomen, or upper arm.
Self-Administration: Patients may self-administer after proper training by a healthcare professional.
Room Temperature: Allow the pre-filled syringe or pen to reach room temperature (approximately 30 minutes) before injection.
3. Mechanism of Action
IL-17A Inhibition: Xeligekimab is a human, hinge-stabilized IgG4κ antibody that selectively binds to interleukin-17A (IL-17A).
Anti-inflammatory Effect: By inhibiting IL-17A, it blocks the interaction with the IL-17 receptor, reducing the release of pro-inflammatory cytokines and chemokines involved in immune-mediated inflammatory diseases.
4. Safety and Warnings
Infections: The drug may increase the risk of infections, particularly upper respiratory tract infections and candidiasis.
Inflammatory Bowel Disease: Xeligekimab may cause new onset or exacerbate pre-existing Crohn’s disease and ulcerative colitis.
Hypersensitivity: Severe allergic reactions may occur. The drug is contraindicated in patients with known severe hypersensitivity to the active ingredient or excipients.
Tuberculosis: Patients should be evaluated for tuberculosis before initiation; active TB must be treated prior to use.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Upper respiratory tract infection and injection site reactions.
Clinical Research Highlights: In a Phase 3 randomized, double-blind, placebo-controlled trial, 90.7% of patients in the xeligekimab group achieved at least 75% improvement in the Psoriasis Area and Severity Index (PASI 75) by Week 12, compared to 8.6% in the placebo group.
6. Drug Interactions
Live Vaccines: The concurrent use of live or attenuated vaccines should be avoided during treatment.
CYP Substrates: As an IL-17A antagonist, the drug may normalize the formation of CYP enzymes during chronic inflammation. Monitoring may be considered for narrow therapeutic index drugs (e.g., cyclosporine, warfarin).
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Xeligekimab. Excipients include histidine, hydrochloric acid, sucrose, methionine, polysorbate 80, and water for injection.
Appearance: Colorless to pale yellow clear to slightly opalescent liquid.
Packaging: Single-dose pre-filled syringes (e.g., 100 mg/1 mL).
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake. Protect from light.