Inclisiran

Pronunciation: in-KLIS-i-ran.

Generic name: inclisiran
Brand names: LEQVIO
Drug class: PCSK9-directed small interfering RNA (siRNA) lipid-lowering medicine
Form: Single-dose pre-filled syringe
Route: Subcutaneous injection
Legal status: Prescription-only, healthcare-professional-administered medicine

Supply Rules Vary

Trade names by country: United States · United Kingdom · Australia

Australia: LEQVIO (5) · Full directory

What inclisiran is and how it works

Inclisiran is a cholesterol-lowering medicine that uses RNA interference in liver cells to reduce production of PCSK9. This increases recycling of LDL receptors and lowers LDL cholesterol in the blood. (1) (2) (3) (4)

Inclisiran is used alongside diet and other risk-reduction measures for eligible adults who need additional LDL-cholesterol lowering. The exact indication and relationship to statins or other lipid-lowering medicines differ by country. It is administered by a healthcare professional and does not replace other prescribed treatment unless the responsible clinician changes the plan.

Mechanism of action: how inclisiran works

Inclisiran is a GalNAc-conjugated double-stranded siRNA taken up by hepatocytes. It directs degradation of PCSK9 mRNA, increasing hepatocyte LDL-receptor availability and lowering circulating LDL-C. (1) (3)

What inclisiran is used for

Hypercholesterolaemia

The current US label includes adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, as an adjunct to diet and exercise. It does not require every patient to have the same cardiovascular-risk category. (1)

Primary hypercholesterolaemia or mixed dyslipidaemia in the UK

Current UK product information includes eligible adults whose LDL-C goals are not reached with maximum tolerated statin treatment, or who are statin-intolerant or have a statin contraindication, alongside diet and other indicated lipid-lowering therapy. (3)

Australian approved use

Australian approval includes eligible adults with heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or high cardiovascular-event risk, with background diet, exercise, and lipid-lowering-treatment criteria. (4)

Before taking inclisiran

Do not take / not appropriate for

Do not receive inclisiran after a serious hypersensitivity reaction to inclisiran or a product ingredient. (all products) (1) (3)

Tell your clinician about

Any previous reaction to inclisiran or another injectable medicine.
Every cholesterol medicine and whether a statin was ineffective, not tolerated, or contraindicated.
Severe kidney disease, dialysis, severe liver disease, or an upcoming dialysis session.
Pregnancy, plans for pregnancy, or breastfeeding.
All medicines, supplements, recent lipid results, and any injection-site infection, rash, burn, or injury.

(1) (2) (3)

How to take inclisiran

Inclisiran is given under the skin by a healthcare professional.
The standard product schedule has an initial injection, another at three months, and then an injection every six months, but appointments and any schedule reset must be managed by the treating service.
Continue diet, exercise, statins, and other prescribed risk-reduction treatment unless the responsible clinician changes them.
Do not attempt to obtain, store, or inject inclisiran yourself.

(1) (2) (3)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)

Missed dose

Contact the treating clinic to reschedule. The current labels use different actions depending on how late the appointment is, including whether the original schedule can continue or must restart. Do not calculate or arrange an extra dose yourself.

Overdose

If a duplicate or incorrect injection may have been administered, the clinical service should identify the product and timing, contact appropriate specialist or poison-information support, and provide symptom-based monitoring. There is no patient-managed antidote. (3)

Side effects

Injection-site effects are the principal commonly reported adverse reactions. A systemic allergic reaction requires urgent assessment.

Injection-site reaction

What to notice: Pain, redness, rash, swelling, tenderness, or another local reaction where the injection was given.

What to do: Tell the clinic if the reaction is severe, worsening, persistent, or accompanied by general allergic symptoms. (1) (2) (3)

Unexpected systemic or liver-related symptoms

What to notice: Widespread rash, facial swelling, unusual persistent tiredness, yellowing of the eyes or skin, dark urine, or other unexpected symptoms.

What to do: Seek prompt clinical advice; emergency assessment is required for breathing or facial/throat symptoms. (1) (3)

Serious warnings

Serious hypersensitivity — emergency

Symptoms: Trouble breathing, swelling of the face, lips, tongue, or throat, widespread hives, faintness, or collapse.

Action: Call emergency services immediately. Do not receive another dose until assessed by the responsible clinician. (1)

Dialysis timing — high_caution

Symptoms: A scheduled haemodialysis session close to an inclisiran appointment.

Action: Tell both teams before treatment. Current UK product information advises that haemodialysis should not be performed for at least 72 hours after dosing. (3)

Interactions

Medicine or test	Effect	Action
Statins and other lipid-lowering medicines	Inclisiran is commonly used with background lipid-lowering therapy. Limited product data do not suggest clinically meaningful pharmacokinetic interactions with common statins, but each medicine retains its own adverse effects and monitoring needs.	Continue or change background treatment only through the prescriber. (3)
Other injections and medicines	No broad clinically significant CYP-mediated interaction is expected, but that does not establish compatibility in the same syringe or eliminate medicine-specific risks.	Provide a complete medicine list. Do not mix inclisiran with another medicine or inject it outside the healthcare setting. (3)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Current human data are limited. UK product information recommends avoiding inclisiran during pregnancy as a precaution. Discuss treatment timing and cardiovascular risk with the specialist. (1) (3)

Breastfeeding

Evidence is limited and country labels may frame the decision differently. The clinician should weigh breastfeeding benefits, treatment need, and potential infant risk. (1) (3)

Kidney or liver impairment

Severe kidney or liver disease and dialysis require individual review. A general website must not turn product-label population data into a personal dosing decision. (3)

Children and adolescents

Current referenced indications are for adults. Safety and effectiveness below 18 years have not been established in the UK product information. (3)

Monitoring

Before starting

Confirm the country-specific indication and cardiovascular-risk or hypercholesterolaemia context.
Review LDL-C, diet, exercise, adherence, statin tolerance or contraindication, and other lipid-lowering treatment.
Review previous hypersensitivity, pregnancy, kidney and liver function context, dialysis timing, medicines, and injection-site skin.

During treatment

Measure LDL-C when clinically indicated and assess whether the overall risk-reduction plan is being followed.
Record injection dates and manage missed appointments through the product-specific schedule.
Assess injection-site and hypersensitivity reactions and continue monitoring required by background lipid-lowering medicines.

(1) (2) (3)

Storage

Storage and product inspection are managed by the supplying clinical service. Current UK product information says not to freeze the pre-filled syringe. The patient should not obtain or store it for self-administration.

Study the drug class: PCSK9 inhibitors

Professional information

Clinician-facing context only. Use the current local indication, product information, schedule, missed-dose rule, lipid guideline, and complete cardiovascular-risk plan.

All regions

Indication: Eligible adult hypercholesterolaemia or dyslipidaemia

Dose summary: The referenced products use a 284 mg subcutaneous healthcare-administered dose initially, at three months, then every six months. Verify exact local indication, salt expression, schedule, missed-dose action, and product before administration.

Renal context: Use the current label for severe renal impairment, end-stage disease, hepatic impairment, and dialysis timing; do not infer patient-specific changes from this summary. (1) (3)

Mechanism of action

Hepatic guidance

UK product information advises caution in severe hepatic impairment; current local labeling and clinical context control use.

Overdose note

No specific antidote is described; identify the medication error and provide clinical observation and supportive care. (1) (3)

Frequently asked questions

Does inclisiran replace my statin?

Usually not automatically. Inclisiran is used within a broader LDL-lowering and cardiovascular-risk plan. Continue existing medicines unless the prescriber changes them. (3) (4)

Can I inject inclisiran at home?

The current referenced products are administered by a healthcare professional. Do not self-inject or arrange a dose outside the treating service. (1) (3)

Has inclisiran been proven to prevent a specific number of heart attacks or strokes?

Inclisiran has demonstrated LDL-C lowering and has country-specific approved indications. Do not interpret that alone as proof of a particular reduction in heart attacks, strokes, or mortality; discuss current outcome evidence and your overall risk plan with the clinician. (3)

What is the mechanism of action of inclisiran?

What is the generic name of Inclisiran?

The generic name is inclisiran. It is sold under brand names including LEQVIO. (1) (2) (3)

What class of drug is inclisiran?

Inclisiran is classed as: PCSK9-directed small interfering RNA (siRNA) lipid-lowering medicine. (1) (2) (3)

References

LEQVIO (inclisiran) injection — prescribing informationU.S. Food and Drug Administration · United States · dated 2025 · accessed 2026-07-22 · source 1
Inclisiran injection: MedlinePlus Drug InformationMedlinePlus, U.S. National Library of Medicine · United States · accessed 2026-07-22 · source 2
Leqvio 284 mg solution for injection in pre-filled syringe — Summary of Product Characteristicselectronic Medicines Compendium (UK) · United Kingdom · dated 2025-11-25 · accessed 2026-07-22 · source 3
Leqvio — Australian prescription medicine decision summaryTherapeutic Goods Administration · Australia · dated 2021-09-22 · accessed 2026-07-22 · source 4
LEQVIO inclisiran 284 mg/1.5 mL pre-filled syringe — ARTG 342250Therapeutic Goods Administration · Australia · accessed 2026-07-22 · source 5

Brand names by country

Single-ingredient inclisiran names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

LEQVIO284 mg.5mL · novartis pharmaceuticals corporation

United Kingdom

Leqvio (3)current licensed product · 284 mg/1.5 mL · Novartis Pharmaceuticals UK Ltd

Australia

LEQVIO (5)current register product · 284 mg/1.5 mL · Novartis Pharmaceuticals Australia Pty Ltd

View brands in additional countries.