Aidaro Ebdarokimab Injection

1. Indications and Usage
Moderate to Severe Plaque Psoriasis: Treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and have had inadequate response, contraindications, or intolerance to cyclosporine, methotrexate (MYX), or PUVA.
2. Dosage and Administration
Route of Administration: For Subcutaneous (SC) Injection ONLY.
Recommended Dosage: 135 mg administered subcutaneously at Week 0 and Week 4, followed by maintenance dosing of 135 mg every 12 weeks.
Critical Administration Instructions:
Site Selection: Administer in the abdomen or thigh. Rotation of injection sites is recommended. If possible, avoid psoriatic lesions as injection sites.
Handling: Do not shake vigorously. Allow the medication to reach room temperature before administration if stored in the refrigerator.
Contraindications for Self-injection: Should be administered under the guidance and supervision of a physician experienced in diagnosing and treating this indication.
3. Mechanism of Action
Target Binding: It is a fully human IgG1 monoclonal antibody that specifically binds to the p40 subunit of IL-12 and IL-23.
Inhibition: By binding to this subunit, it inhibits the interaction with cell surface receptors, blocking the signaling pathways of both IL-12 and IL-23.
Immunomodulation: This reduces the release of T-cell-derived pro-inflammatory cytokines (such as interferon-gamma, TNF-α, and IL-17), thereby suppressing the inflammatory response and controlling the progression of psoriasis.
4. Safety and Warnings
Hypersensitivity: Contraindicated in patients with serious hypersensitivity reactions to the drug or any of its excipients.
Infections: As an immunomodulator, it may increase the risk of infections. Patients with active chronic or localized infections should be monitored closely.
Pregnancy and Lactation: Safety data for use in pregnant and lactating women are insufficient; risks and benefits must be carefully evaluated before use.
Inflammatory Bowel Disease: Use with caution in patients with active inflammatory bowel disease (e.g., Crohn’s disease), as IL-12/23 pathway inhibition has been associated with IBD development or exacerbation in some contexts.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Injection site reactions (pain, redness, swelling, pruritus) are the most frequently reported adverse reactions.
Other Common Adverse Reactions: Upper respiratory tract infections, headache, fatigue, and skin and subcutaneous tissue diseases (urticaria, eczema, dermatitis).
Laboratory Abnormalities: Increases in blood bilirubin have been observed.
Clinical Research Highlights: Phase 3 clinical trials demonstrated that the fixed dosing regimen of 135 mg achieved significant improvement in Psoriasis Area and Severity Index (PASI) scores with a generally favorable safety profile.
6. Drug Interactions
Live Vaccines: The use of live or attenuated vaccines should generally be avoided during treatment due to the risk of infection.
Other Immunomodulators: Concomitant use with other immunosuppressive agents or biologics is not recommended, as it may increase the risk of infection or immunogenicity.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Ebdarokimab (fully human monoclonal antibody). Excipients: Sodium chloride, histidine, polysorbate 20, water for injection.
Appearance: Clear to slightly opalescent, colorless to pale yellow solution.
Packaging: Single-use pre-filled pen or syringe (135 mg/0.9 mL).
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake. Protect from light.