risankizumab: clinical use

Prescribing considerations

• Specialist initiation and supervision are required.
• Assess current, chronic and recurrent infections and relevant infection risk factors before starting.
• Review vaccination status before treatment; allow an appropriate interval after any recent live vaccine.
• For psoriatic arthritis, the licensed indication permits use alone or with methotrexate.
• Record the product name and batch number for biological-medicine traceability.

Contraindications and cautions

• Hypersensitivity to risankizumab or a formulation excipient.
• Clinically important active infection, including active tuberculosis.

Monitoring

• Evaluate for tuberculosis before treatment and monitor for symptoms of active tuberculosis.
• Monitor clinically for infection; interrupt administration during a clinically important infection until it has resolved.
• Review disease response and ongoing treatment benefit.
• Watch for immediate or delayed hypersensitivity reactions.

Clinical pharmacology

Risankizumab is a humanised IgG1 monoclonal antibody targeting the p19 subunit of IL-23. It is primarily cleared through intracellular protein catabolism rather than cytochrome P450 metabolism or renal elimination.

Formulation and product differences

• The pre-filled syringe is a single-use subcutaneous presentation licensed for plaque psoriasis and adult psoriatic arthritis.
• The concentrate is diluted for intravenous infusion by a healthcare professional and is licensed for initial treatment of Crohn’s disease and ulcerative colitis.
• Subcutaneous maintenance treatment for inflammatory bowel disease uses separate cartridge presentations; the selected pre-filled syringe is not the licensed bowel-disease maintenance device.
• Both selected formulations contain polysorbate 20, which may cause allergic reactions.

Solution for infusion

Route: Intravenous

Strengths: 600 mg

Injection

Route: Parenteral

Strengths: 150 mg, 180 mg, 360 mg