mirikizumab: clinical use

Prescribing considerations

• Treatment should be supervised by a physician experienced in ulcerative colitis or Crohn’s disease.
• Assess current, chronic and recurrent infections and complete appropriate immunisations before treatment where possible.
• Evaluate for tuberculosis before initiation; consider treatment where previous latent or active tuberculosis was not adequately treated.
• Record the product name and batch number for biological traceability.

Contraindications and cautions

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

Monitoring

• Assess clinical response and ongoing need for treatment.
• Check liver enzymes and bilirubin at baseline and subsequently according to clinical practice and indication.
• Monitor for infection and active tuberculosis during and after treatment.
• Stop mirikizumab while suspected drug-induced liver injury is investigated.

Clinical pharmacology

Mirikizumab is a humanised IgG4 monoclonal antibody targeting the p19 subunit of IL-23. Like endogenous IgG, it is expected to undergo catabolism into small peptides and amino acids rather than conventional hepatic metabolism.

Formulation and product differences

• The concentrate for intravenous infusion is restricted to the initial treatment phase and must be diluted and administered by healthcare professionals.
• Pre-filled pens are for subcutaneous maintenance treatment and may be self-administered after training.
• The selected pen products have disease-specific licensed roles and should not be assumed to be interchangeable without checking the relevant product information.

Solution for infusion

Route: Intravenous

Strengths: 300 mg

Injection

Route: Parenteral

Strengths: 100 mg, 200 mg