Andajing Vunakizumab Injection

1. Indications and Usage
Vunakizumab injection is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are eligible for systemic therapy or phototherapy.
2. Dosage and Administration
Recommended Dosage: The recommended dosage is 240 mg (two 120 mg injections), administered as subcutaneous injections.
Schedule: Injections are given at Week 0, Week 2, and Week 4, followed by once every 4 weeks thereafter.
Administration: Subcutaneous injection. Avoid injecting into psoriatic lesions. Patients may be trained to self-administer under professional guidance.
3. Mechanism of Action
Vunakizumab is a recombinant humanized monoclonal antibody that specifically binds to Interleukin-17A (IL-17A). It inhibits the interaction between IL-17A and its receptors, thereby blocking the release of pro-inflammatory cytokines and chemokines involved in the pathogenesis of psoriasis.
4. Safety and Warnings
Infections: May increase the risk of infections. Active tuberculosis must be ruled out before initiation. Latent TB requires treatment prior to therapy.
Hypersensitivity: Serious allergic reactions may occur; discontinue if confirmed.
Inflammatory Bowel Disease (IBD): May cause new onset or exacerbation of IBD; monitor for gastrointestinal symptoms.
Embryo-Fetal Toxicity: Safety during pregnancy and lactation has not been established.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include nasopharyngitis, headache, arthralgia, nausea, fatigue, upper respiratory tract infection, and injection site reactions.
Clinical Research: Efficacy and safety were established in phase 3 clinical trials (e.g., VISION study) demonstrating significant improvement in Psoriasis Area and Severity Index (PASI) scores compared to placebo.
6. Drug Interactions
Immunosuppressants: Concomitant use with other immunosuppressive agents may increase the risk of infection.
Vaccines: Live or live-attenuated vaccines should be avoided during treatment. Consider completing necessary vaccinations before initiating therapy.
7. Pharmaceutical Information
Composition: Active ingredient is vunakizumab. Excipients include histidine, polysorbate 80, sucrose, and water for injection.
Appearance: Pale yellow to colorless clear liquid.
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake. Protect from light.