ustekinumab: clinical use

Prescribing considerations

• Initiate and supervise through clinicians experienced in the relevant licensed condition.
• Assess for infection and tuberculosis before treatment.
• Review malignancy history, vaccination needs, concurrent immunosuppression and pregnancy or breastfeeding plans.
• Record brand and batch number for biological-medicine traceability.

Contraindications and cautions

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

Monitoring

• Monitor for infection and active tuberculosis during and after treatment; withhold administration during serious infection until resolved.
• Monitor clinical response and tolerability.
• Check for new or changing skin lesions.
• Investigate persistent cough or breathlessness and suspected serious hypersensitivity, severe skin disease or lupus-related reactions promptly.

Clinical pharmacology

A fully human IgG1κ monoclonal antibody that binds the shared p40 subunit of interleukin-12 and interleukin-23, interrupting associated inflammatory pathways.

Formulation and product differences

• The solution for injection is for subcutaneous administration and may be administered by a trained patient or caregiver when appropriate.
• The concentrate for infusion requires dilution and intravenous administration by healthcare professionals.
• The formulations are not interchangeable by route; use the prescribed presentation and device instructions.

Solution for infusion

Route: Intravenous

Strengths: 130 mg

Injection

Route: Parenteral

Strengths: 45 mg, 90 mg