sarilumab: clinical use

Prescribing considerations

• Initiation and supervision should be by a clinician experienced in the relevant inflammatory condition.
• Assess current, recurrent and opportunistic infection risk, including tuberculosis exposure and viral-reactivation risk.
• Review immunisations before treatment and provide the patient safety card.
• Use caution with previous diverticulitis or intestinal ulceration, particularly alongside treatments associated with gastrointestinal injury.
• Record product name and batch number for biological-medicine traceability.

Contraindications and cautions

• Hypersensitivity to sarilumab or an excipient
• Active severe infection

Monitoring

• Screen for latent tuberculosis and assess infection risk before initiation.
• Check neutrophils, platelets and liver enzymes before and during treatment; apply product-specific interruption or discontinuation criteria.
• Assess lipid parameters after initiation and periodically thereafter.
• Promptly investigate infection, persistent abdominal symptoms or gastrointestinal bleeding.
• Review CYP-substrate medicines with a narrow therapeutic index when sarilumab is started or stopped.

Clinical pharmacology

Sarilumab is a human IgG1 monoclonal antibody that binds soluble and membrane-bound IL-6 receptors and inhibits IL-6-mediated gp130 and STAT3 signalling. Like endogenous IgG, it is expected to undergo proteolytic catabolism rather than conventional renal or hepatic elimination.

Formulation and product differences

• The selected product is a single-use pre-filled pen for subcutaneous administration.
• The pen may be used by the patient or caregiver after competency-based training.
• Keep refrigerated in the original carton; once removed, observe the product's temperature and use-by restrictions and do not return unsuitable pens to use.

Injection

Route: Parenteral

Strengths: 150 mg, 200 mg