- Indications and Usage Plaque Psoriasis: Indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Psoriatic Arthritis: Indicated for the treatment of adult patients with active psoriatic arthritis. Crohns Disease (CD): Indicated for the treatment of adult patients with moderately to severely active Crohns disease. Ulcerative Colitis (UC): Indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
- Dosage and Administration Plaque Psoriasis & Psoriatic Arthritis: 150 mg administered subcutaneously at Weeks 0 and 4, followed by every 12 weeks thereafter. Crohns Disease: Induction with 600 mg intravenous infusion at Weeks 0, 4, and 8, followed by 180 mg or 360 mg subcutaneously starting at Week 12, and every 8 weeks thereafter. Ulcerative Colitis: Induction with 1200 mg intravenous infusion at Weeks 0, 4, and 8, followed by 180 mg or 360 mg subcutaneously starting at Week 12, and every 8 weeks thereafter. Missed Dose: Missed subcutaneous doses should be administered as soon as possible. Subsequent doses are reinstituted at the appropriate interval from the administered dose.
- Mechanism of Action IL-23 Inhibitor: Risankizumab selectively binds to the p19 subunit of the human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. Pathway Blocking: IL-23 is a natural cytokine that plays a key role in the inflammatory process. Risankizumab blocks this pathway, reducing the release of pro-inflammatory cytokines and chemokines.
- Safety and Warnings Serious Infections: Risankizumab may increase the susceptibility to infections. Evaluate patients for tuberculosis before initiating therapy. No data is available on the use of risankizumab in patients with active, chronic, or recurrent infections. Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. Permanently discontinue if a severe reaction occurs. Immunization: Avoid the use of live vaccines during treatment with risankizumab.
- Adverse Reactions and Clinical Research Common Adverse Reactions: The most common adverse reactions (incidence ≥1%) include upper respiratory tract infection, headache, fatigue, injection site reactions, and fungal infections (tinea). Liver Enzyme Elevation: In Crohns disease clinical trials, increases in liver enzymes and bilirubin were observed; baseline and monitoring of liver parameters are recommended prior to induction.
- Drug Interactions Immunosuppressants: Clinical studies have not formally evaluated the interaction between risankizumab and other immunosuppressive agents. Vaccines: Live vaccines should be avoided due to the theoretical risk of inducing an infection.
- Pharmaceutical Information Active Ingredient: Risankizumab (a recombinant humanized monoclonal immunoglobulin G1kappa antibody). Dosage Forms: Solution for injection (Subcutaneous: 90 mg/0.83 mL, 150 mg/1.2 mL, 180 mg/1.2 mL; Intravenous: 600 mg/10 mL). Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light. Keep in the original carton until time of use.
Skyrizi Risankizumab Injection
Brand Name: 喜开悦 ®（Skyrizi®）
Generic Name: Risankizumab
Strength: 600 mg per 10 mL vial, 1 vial per box
Manufacturer: Patheon Italia S.p.A.
Marketing Authorization Holder: AbbVie Inc. (Domestic distributor: AbbVie Pharmaceutical Trading (Shanghai) Co., Ltd.)
Approval Date in China: March 10, 2025
Registration Number: 国药准字SJ20260002
Storage: Store refrigerated at 2°C–8°C, do not freeze, protect from light. Do not shake violently. Refer to the full package insert for detailed storage specifications.
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