guselkumab: clinical use

Prescribing considerations

• Treatment should be initiated and supervised by a clinician experienced in the relevant condition.
• Assess clinically important infection, tuberculosis history and vaccination status before initiation.
• Serious hypersensitivity may occur immediately or several days after administration.
• Evidence in older adults is limited, particularly in those aged 75 years and over.
• Record the product name and batch number for biologic traceability.

Contraindications and cautions

• Serious hypersensitivity to guselkumab or a listed excipient.
• Clinically important active infection, including active tuberculosis.

Monitoring

• Screen for tuberculosis before treatment and remain alert for active tuberculosis during and after treatment.
• Monitor for infection and interrupt treatment if a clinically important or serious infection develops until resolved.
• Follow product-specific liver-function monitoring requirements and investigate suspected drug-induced liver injury.
• Monitor for hypersensitivity during and after administration; delayed reactions are possible.

Clinical pharmacology

Guselkumab is a fully human IgG1 lambda monoclonal antibody targeting IL-23. It is expected to undergo normal IgG catabolism to peptides and amino acids; its mean half-life is approximately 15–18 days across licensed populations.

Formulation and product differences

• The PushPen is a single-use, ready-to-inject subcutaneous presentation that may be self-administered after training and clinical approval.
• The infusion concentrate is licensed for Crohn’s disease and ulcerative colitis, requires dilution in sodium chloride solution and must be prepared and administered by a healthcare professional.
• Both formulations are refrigerated, protected from light and must not be frozen or shaken.

Solution for infusion

Route: Intravenous

Strengths: 200 mg

Injection

Route: Parenteral

Strengths: 45 mg/0.45 mL, 100 mg, 200 mg