spesolimab: clinical use

Prescribing considerations

• Initiate and supervise through an inflammatory skin disease specialist.
• Assess chronic or recurrent infection, tuberculosis history or exposure, vaccination status and concurrent immunosuppression before treatment.
• Evidence for retreatment of later flares is very limited.
• There is no clinical experience in immediately life-threatening flares or flares requiring intensive care.
• Record product name and batch number because this is a biological product under additional monitoring.

Contraindications and cautions

• Severe or life-threatening hypersensitivity to spesolimab or an excipient.
• Clinically important active infection, including active tuberculosis.

Monitoring

• Evaluate for tuberculosis before treatment and monitor for active disease afterwards.
• Monitor for infection and immediate or delayed hypersensitivity.
• Observe during infusion and manage infusion-related reactions promptly.
• Remain vigilant for new peripheral neuropathy symptoms.
• Report suspected adverse reactions through the Yellow Card Scheme.

Clinical pharmacology

Spesolimab is a humanised IgG1 monoclonal antibody that antagonises IL-36 receptor signalling. Like endogenous IgG, it is expected to undergo catabolic degradation into peptides and amino acids rather than hepatic or renal elimination.

Formulation and product differences

• The selected product is a single-use vial concentrate requiring dilution for intravenous infusion.
• It must not be administered as an intravenous bolus or mixed with other medicines outside the specified preparation instructions.
• Separate pre-filled syringe presentations use subcutaneous administration and should not be confused with this infusion formulation.

Solution for infusion

Route: Intravenous

Strengths: 450 mg