linaclotide: clinical use

Prescribing considerations

• Confirm moderate to severe IBS-C after excluding relevant organic disease.
• Reassess benefit and continued need periodically.
• Use additional caution in older people and those vulnerable to fluid or electrolyte disturbance.
• Not recommended in chronic inflammatory intestinal disorders such as Crohn’s disease or ulcerative colitis, as it has not been studied in these groups.

Contraindications and cautions

• Hypersensitivity to linaclotide or any excipient.
• Known or suspected mechanical gastrointestinal obstruction.

Monitoring

• Assess severe or prolonged diarrhoea and consider interruption until it resolves.
• Consider electrolyte assessment for diarrhoea in people vulnerable to fluid or electrolyte imbalance.
• Investigate lower gastrointestinal bleeding and severe, persistent or worsening abdominal pain promptly.
• Monitor older patients carefully because diarrhoea occurred more frequently in clinical trials.

Clinical pharmacology

A locally acting synthetic peptide and guanylate cyclase-C agonist. It increases intestinal cyclic GMP, chloride and bicarbonate secretion, luminal fluid and transit. Systemic exposure is negligible.

Formulation and product differences

• The selected product is a hard gelatin capsule.
• It is supplied in a moisture-protective bottle containing a sealed silica-gel desiccant canister.
• No alternative formulation is represented by the selected product.

Capsule

Route: Oral

Strengths: 290 micrograms