dupilumab: clinical use

Prescribing considerations

• Confirm the licensed indication and relevant disease phenotype before initiation.
• Treat known helminth infection before starting and interrupt dupilumab if infection fails to respond to anti-helminth treatment.
• Review live-vaccine requirements before treatment.
• Do not use for acute bronchospasm or acute asthma or COPD exacerbations.
• Avoid abrupt corticosteroid withdrawal.
• Record product name and batch number for biological traceability.

Contraindications and cautions

• Hypersensitivity to dupilumab or any product excipient.

Monitoring

• Assess clinical response using indication-appropriate outcomes.
• Ask about new or worsening ocular symptoms and arrange ophthalmology assessment where indicated.
• Monitor for immediate or delayed systemic hypersensitivity.
• Investigate eosinophilia with pulmonary, cardiac, neurological or vasculitic features.
• Monitor comorbid asthma carefully if dupilumab is discontinued.

Clinical pharmacology

Dupilumab is a recombinant fully human IgG4 monoclonal antibody against IL-4Rα. It inhibits IL-4 and IL-13 signalling and is expected to be degraded into peptides and amino acids rather than undergo conventional CYP metabolism.

Formulation and product differences

• The selected presentation is a single-use pre-filled syringe with a needle shield.
• The pre-filled syringe can be used from 6 months of age; the pre-filled pen is intended for patients aged 2 years and older.
• The syringe should be refrigerated, protected from light and not frozen. It may remain in its carton at up to 25°C for no more than 14 days.

Injection

Route: Parenteral

Strengths: 200 mg, 300 mg