alirocumab: clinical use

Prescribing considerations

• Exclude secondary causes of hyperlipidaemia before initiation.
• Use alongside dietary management and correction of other cardiovascular risk factors.
• Ensure training in correct subcutaneous administration.
• Record the product name and batch number for traceability.
• Use caution in severe renal impairment; evidence is absent in severe hepatic impairment.

Contraindications and cautions

• Hypersensitivity to alirocumab or any formulation excipient.

Monitoring

• Measure lipid profile to assess LDL-cholesterol response.
• Review injection-site reactions and symptoms of systemic hypersensitivity.
• Confirm storage, injection technique and adherence where response is below expectation.

Clinical pharmacology

Alirocumab is a fully human IgG1 monoclonal antibody that prevents PCSK9-mediated degradation of hepatic LDL receptors. It is expected to be broken down into peptides and amino acids through target-mediated and proteolytic pathways.

Formulation and product differences

• The selected product is a clear, colourless to pale-yellow solution in a single-use pre-filled pen.
• Current presentations may use a pen with an activation button or a buttonless device; follow device-specific instructions.
• Not all presentations or pack sizes may be marketed.

Injection

Route: Parenteral

Strengths: 75 mg, 150 mg, 300 mg