Lipid-Lowering Agents Pregnancy: As a precautionary measure, preferable to avoid during pregnancy (limited data). Breast-feeding: a decision to discontinue breast-feeding or therapy should weigh benefits, as a risk to the infant cannot be excluded.

Inclisiran

Brand names: Leqvio

Inclisiran is a small interfering RNA (siRNA) cholesterol-lowering agent given by subcutaneous injection, used as an adjunct to diet and statin therapy (or alone when statins are unsuitable) to lower LDL-cholesterol in adults with primary hypercholesterolaemia or mixed dyslipidaemia.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 284 mg as a single subcutaneous injection

Route: Subcutaneous injection (into the abdomen; alternatively upper arm or thigh)

Frequency: Initially, again at 3 months, then every 6 months

Each 284 mg dose is given using a single pre-filled syringe (single use), administered by a healthcare professional. Missed dose: if missed by <3 months, give and continue original schedule; if missed by >3 months, restart schedule (initial dose, again at 3 months, then every 6 months). Transition from a monoclonal antibody PCSK9 inhibitor: can be given immediately after the last dose, ideally within 2 weeks. Elderly: no dose adjustment. Hepatic impairment: no adjustment for mild/moderate (Child-Pugh A/B); use with caution in severe (Child-Pugh C, no data). Paediatric population (<18 years): safety and efficacy not established, no data. Do not inject into areas of active skin disease or injury.

Dose adjustments

Renal

No dose adjustment for mild, moderate or severe renal impairment or end-stage renal disease; use with caution in severe renal impairment (limited experience). Haemodialysis should not be performed for at least 72 hours after dosing.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to inclisiran or to any of the excipients

Side effects

Injection site reaction (common)
Injection site pain
Injection site erythema
Injection site rash
Mild elevations of serum hepatic transaminases (ALT/AST, up to <=3x ULN; asymptomatic)

Interactions

Not a substrate, inhibitor or inducer of cytochrome P450 enzymes or common drug transporters; no clinically significant medicinal-product interactions expected
No clinically meaningful interaction expected with atorvastatin, rosuvastatin or other statins

Clinical monograph

How it works

It uses RNA interference to silence hepatic PCSK9 messenger RNA, reducing PCSK9 protein production so more LDL receptors are recycled to the hepatocyte surface, increasing clearance of circulating LDL-cholesterol.

Prescribing in practice

After the first dose and a dose at three months, maintenance injections are given only twice yearly, so administration must be by a healthcare professional and recorded carefully to avoid missed long-interval doses.
It is an adjunct to maximally tolerated statin therapy rather than a replacement; do not stop background lipid-lowering treatment when starting it.
Injection-site reactions are the most common adverse effect and are usually mild and transient.

Monitoring

Check a lipid profile before starting and periodically thereafter to confirm response, though LDL response is not required to guide the fixed twice-yearly dosing schedule.

Counselling the patient

This is a twice-a-year injection given by your clinic; keep your scheduled appointments as the effect wears off over months if doses are delayed.
Continue your statin or other cholesterol tablets unless your doctor tells you to stop.
Some redness or soreness at the injection site is common and settles quickly.

Evidence & guidelines

NICE recommends inclisiran as an option for adults with persistent high LDL-cholesterol despite maximally tolerated lipid-lowering therapy, supported by the ORION programme of randomised trials.

Reference: ORION-10 NEJM 2020; 382(16):1507-1519; NICE TA733; MHRA 2021; ESC/EAS Lipid Guidelines 2019; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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