adalimumab: clinical use

Prescribing considerations

• Treatment should be initiated and supervised by an appropriately experienced specialist.
• Assess active and latent tuberculosis, hepatitis B status, infection history and immunisation status before treatment.
• Record the prescribed biological product name and batch number for traceability.
• Review recurrent infection, previous malignancy, mild heart failure, demyelinating disease and planned surgery before prescribing.
• Provide a patient reminder card and injection-device training.

Contraindications and cautions

• Hypersensitivity to adalimumab or a formulation excipient.
• Active tuberculosis or another severe infection, including sepsis or an opportunistic infection.
• Moderate to severe heart failure.

Monitoring

• Monitor for infection, including tuberculosis, during treatment and after withdrawal.
• Monitor hepatitis B carriers closely for reactivation.
• Arrange regular specialist blood monitoring, including liver and kidney health checks.
• Assess promptly for new neurological symptoms, cytopenia, lupus-like features or new or worsening heart failure.
• Review skin-cancer risk and investigate suspicious skin lesions.

Clinical pharmacology

Adalimumab is a recombinant human IgG1 monoclonal antibody that neutralises TNF-alpha. Subcutaneous absorption is slow and the mean terminal half-life is approximately two weeks.

Formulation and product differences

• Selected products differ in concentration, excipients, device components and room-temperature storage limits; instructions are not interchangeable.
• The selected Idacio syringe has a latex-free needle cap and permits a single room-temperature period of up to 28 days when protected from light.
• The selected AMGEVITA HCF syringe permits room-temperature storage for up to 14 days when protected from light.

Injection

Route: Parenteral

Strengths: 20 mg, 40 mg, 40 mg/0.4 mL, 40 mg/0.8 mL, 80 mg, 80 mg/0.8 mL