inclisiran sodium: clinical use

Prescribing considerations

• Confirm primary hypercholesterolaemia or mixed dyslipidaemia and document background diet and lipid-lowering therapy.
• Clarify statin tolerance, contraindications and the maximum tolerated regimen.
• Administration is restricted to healthcare professionals; avoid inflamed, infected or injured injection sites.
• Safety and efficacy have not been established in people younger than 18 years.
• Use caution in severe renal impairment because clinical experience is limited.
• Use caution in severe hepatic impairment because clinical data are unavailable.

Contraindications and cautions

• Hypersensitivity to inclisiran or any excipient.
• Haemodialysis should not be performed for at least 72 hours after administration.

Monitoring

• Use LDL cholesterol to assess pharmacodynamic response and continued need for treatment.
• Review injection-site reactions and report suspected adverse reactions through the MHRA Yellow Card scheme.
• No specific routine safety-laboratory monitoring schedule is stated in the selected SmPC.

Clinical pharmacology

Inclisiran is a GalNAc-conjugated, double-stranded small interfering RNA selectively taken up by hepatocytes. It reduces PCSK9 messenger RNA, increasing hepatic LDL-receptor recycling. It is metabolised by nucleases to inactive nucleotides and is not expected to involve cytochrome P450 metabolism.

Formulation and product differences

• The selected product is a clear, colourless to pale-yellow solution in a single-use pre-filled syringe.
• It is essentially sodium-free, must not be mixed with other medicines and must not be frozen.

Injection

Route: Parenteral

Strengths: 284 mg