Risankizumab Application Scope

Risankizumab is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; and moderately to severely active ulcerative colitis. In China, it was initially approved for adult moderate to severe Crohn’s disease, with potential expansions.

Risankizumab Characteristics

Ingredients: Risankizumab
Properties: Sterile, preservative-free solution; colorless to yellow (clear to slightly opalescent); pH 5.7 for most formulations, pH 6.2 for 90 mg/mL.
Packaging Specification: Subcutaneous: 150 mg/mL single-dose prefilled syringe or pen (1 syringe/pen per carton); 90 mg/mL single-dose prefilled syringe (2 or 4 syringes per carton); 180 mg/1.2 mL (150 mg/mL) single-dose prefilled cartridge with accompanying autoinjector (kit); 360 mg/2.4 mL (150 mg/mL) single-dose prefilled cartridge with accompanying autoinjector (kit). Intravenous: 600 mg/10 mL (60 mg/mL) single-dose vial (1 vial per carton).
Storage: Store in refrigerator at 36°F-46°F (2°C-8°C); do not freeze; protect from light in original carton; do not shake.
Expiry Date: The expiration date is stated on individual vial, syringe, pen, or cartridge labels and outer carton after the designation ‘EXP’. Do not use the medicine after this expiration date.
Executive Standard: U.S. FDA-approved prescribing information; complies with Chinese NMPA standards for approved formulations.
Approval Number: 国药准字SJ20250008 for subcutaneous injection; JXSS2300052 for injection. U.S. License Number 1889.
Date of Revision: June 2024 (based on available prescribing information).
Manufacturer:AbbVie Inc.; in China: AbbVie Pharmaceutical Trading (Shanghai) Co., Ltd.

Guidelines for the Use of Risankizumab

Dosage and Administration:
- Recommended Dose: Plaque psoriasis and psoriatic arthritis: 150 mg subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. Crohn’s disease: Induction: 600 mg intravenous infusion at Week 0, Week 4, and Week 8; Maintenance: 180 mg or 360 mg subcutaneous at Week 12 and every 8 weeks thereafter (use lowest effective dose). Ulcerative colitis: Induction: 1,200 mg intravenous infusion at Week 0, Week 4, and Week 8; Maintenance: 180 mg or 360 mg subcutaneous at Week 12 and every 8 weeks thereafter (use lowest effective dose)
- Administration: Subcutaneous: Administer into thigh or abdomen (upper arm by professional/caregiver); initial doses under supervision, then self-administer after training. Intravenous: Dilute in 5% dextrose or 0.9% sodium chloride; infuse over at least 1 hour (Crohn’s) or 2 hours (ulcerative colitis); do not co-administer with other drugs. Inspect solution before use.
- Missed Dose: Administer as soon as possible, then resume regular schedule. Consult a healthcare professional if needed.
Adverse Reactions:
- Common Adverse Reactions: Upper respiratory tract infections, headache, fatigue, injection site reactions, tinea infections (plaque psoriasis/psoriatic arthritis); arthralgia, abdominal pain, anemia, pyrexia, back pain, arthropathy, urinary tract infection (Crohn’s/ulcerative colitis maintenance).
- Serious Adverse Reactions: Hypersensitivity reactions (e.g., anaphylaxis); infections (including tuberculosis—screen prior); hepatotoxicity (monitor liver enzymes/bilirubin in IBD patients).
Contraindications: Serious hypersensitivity to risankizumab-rzaa or any excipients.
Precautions:
- Evaluate for tuberculosis and complete vaccinations before starting; avoid live vaccines; monitor for infections and hepatotoxicity; train patients on injection technique; rotate injection sites; if overdose occurs, seek medical advice.

Risankizumab Interactions

No clinically significant drug interactions with CYP substrates (e.g., caffeine, warfarin); increased infection risk with live vaccines—avoid concurrent use.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.