Prescribing information (external link)
LEQVIO® (inclisiran) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:1
in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin, or
alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated
For full safety information, please refer to the LEQVIO® Summary of Product Characteristics (SmPC).
LEQVIO® safety profile
LEQVIO® has a safety profile comparable to placebo, with injection-site reactions being the only reported adverse event (8.2% vs placebo 1.8%)1,2
The efficacy and safety profile of LEQVIO® was characterised in the ORION-10 randomised, double-blind, placebo-controlled trial in patients with atherosclerotic cardiovascular disease (ASCVD, or ASCVD risk equivalents)* and the ORION-8 open-label extension.2–4
The most common treatment-emergent adverse events were COVID-19 (13.8%), diabetes mellitus inadequate control (7.0%) and hypertension (7.0%)
The most common treatment-emergent serious adverse events were coronary artery disease (2.0%), COVID-19 (1.5%) and acute myocardial infarction (1.3%)
The only adverse reactions associated with LEQVIO® were injection-site reactions (including pain, redness and rash), which occurred in 8.2% and 1.8% of LEQVIO® and placebo patients, respectively1
All of these adverse reactions were mild or moderate in severity, transient and resolved without sequelae1–3
The most frequently occurring adverse reactions at the injection site in patients treated with LEQVIO® were injection site reaction (3.1%), injection site pain (2.2%), injection site erythema (1.6%), and injection site rash (0.7%)1
0.2% of participants discontinued LEQVIO® due to injection-site reactions vs 0.0% with placebo1
Water for injections
Sodium hydroxide (for pH adjustment)
Concentrated phosphoric acid (for pH adjustment)
With over 12,000 patient-years’ exposure and >20,000 injections, the safety profile of LEQVIO® remains consistent, with no new safety signals identified†4
In ORION-8 (N=3,274), the safety profile of LEQVIO® remained consistent with previous reports, with no new safety signals:4
Well tolerated in pivotal clinical trials1–3
See below for the full list of adverse events in ORION-10.
| LEQVIO® | Placebo | Risk ratio |
Adverse events | No. of patients (%) | ||
≥1 adverse event | 574 (73.5) | 582 (74.8) | 1.0 (0.9–1.0) |
≥1 event leading to discontinuation of LEQVIO® or placebo | 19 (2.4) | 17 (2.2) | 1.1 (0.6–2.1) |
Serious adverse events | No. of patients (%) | ||
≥1 serious adverse event | 175 (22.4) | 205 (26.3) | 0.9 (0.7–1.0) |
Death | 12 (1.5) | 11 (1.4) | 1.1 (0.5–2.4) |
Death from cardiovascular causes | 7 (0.9) | 5 (0.6) | 1.4 (0.4–4.4) |
Cancer-related death | 1 (0.1) | 3 (0.4) | 0.3 (0.0–3.2) |
New, worsening or recurrent cancer | 26 (3.3) | 26 (3.3) | 1.0 (0.6–1.7) |
Other cardiovascular adverse events | No. of patients (%) | ||
Prespecified exploratory cardiovascular endpoint‡ | 58 (7.4) | 79 (10.2) | 0.7 (0.5–1.0) |
Fatal or nonfatal myocardial infarction | 20 (2.6) | 18 (2.3) | 1.1 (0.6–2.1) |
Fatal or nonfatal stroke | 11 (1.4) | 7 (0.9) | 1.6 (0.6–4.0) |
Injection-site adverse events§ | No. of patients (%) | ||
Any reaction | 20 (2.6) | 7 (0.9) | 2.9 (1.2–6.7) |
Mild | 13 (1.7) | 7 (0.9) | 1.9 (0.7–4.6) |
Moderate | 7 (0.9) | 0 | _ |
Severe | 0 | 0 | _ |
Persistent | 0 | 0 | _ |
Frequent adverse events¶ | No. of patients (%) | ||
Diabetes mellitus | 120 (15.4) | 108 (13.9) | 1.1 (0.9–1.4) |
Nasopharyngitis | _ | _ | _ |
Bronchitis | 46 (5.9) | 30 (3.9) | 1.5 (1.0–2.4) |
Dyspnoea | 39 (5.0) | 33 (4.2) | 1.2 (0.7–1.9) |
Hypertension | 42 (5.4) | 42 (5.4) | 1.0 (0.7–1.5) |
Upper respiratory tract infection | 39 (5.0) | 33 (4.2) | 1.2 (0.7–1.9) |
Arthralgia | _ | _ | _ |
Osteoarthritis | _ | _ | _ |
Back pain | 39 (5.0) | 39 (5.0) | 1.0 (0.6–1.5) |
Laboratory results | No. of patients (%) | ||
Liver function | |||
Alanine aminotransferase >3×ULN | 2 (0.3) | 2 (0.3) | 1.0 (0.1–7.1) |
Aspartate aminotransferase >3×ULN | 4 (0.5) | 5 (0.6) | 0.8 (0.2–3.0) |
Alkaline phosphatase >3×ULN | 5 (0.6) | 3 (0.4) | 1.7 (0.4–6.9) |
Bilirubin >2×ULN | 4 (0.5) | 3 (0.4) | 1.3 (0.3–5.9) |
Kidney function: creatinine >2 mg/dL | 30 (3.8) | 30 (3.9) | 1.0 (0.6–1.6) |
Muscle: creatine kinase >5×ULN | 10 (1.3) | 8 (1.0) | 1.2 (0.5–3.1) |
Haematology: platelet count <75×109/litre | 1 (0.1) | 0 | _ |
Adapted from Ray KK, et al. 2020.2
Treatment transition from monoclonal antibody PCSK9 inhibitors1
LEQVIO® can be administered immediately after the last dose of a monoclonal antibody PCSK9 inhibitor. To maintain LDL-C lowering, it is recommended that LEQVIO® is administered within 2 weeks after the last dose of a monoclonal antibody PCSK9 inhibitor.
Special populations1
Elderly (age ≥65 years)
No dose adjustment is necessary in elderly patients (see section 5.2 of the SmPC).
Hepatic impairment
No dose adjustments are necessary for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. No data are available in patients with severe hepatic impairment (Child-Pugh class C) (see section 5.2 of the SmPC). LEQVIO® should be used with caution in patients with severe hepatic impairment.
Renal impairment
No dose adjustments are necessary for patients with mild, moderate or severe renal impairment or patients with end-stage renal disease (see section 5.2 of the SmPC). There is limited experience with LEQVIO® in patients with severe renal impairment. LEQVIO® should be used with caution in these patients.
Paediatric population
The safety and efficacy of LEQVIO® in children aged less than 18 years have not yet been established. No data are available.
Contraindications1
Hypersensitivity to the active substance or to any of the following excipients:
Special warnings and precautions for use1
Haemodialysis:
The effects of haemodialysis on LEQVIO® pharmacokinetics have not been studied. Considering that LEQVIO® is eliminated renally, haemodialysis should not be performed for at least 72 hours after LEQVIO® dosing.
Sodium content:
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Please refer to the SmPC for full information on special warnings and precautions
Interaction with other medicinal products and other forms of interaction1
LEQVIO® is not a substrate for common drug transporters and, although in vitro studies were not conducted, it is not anticipated to be a substrate for cytochrome P450. LEQVIO® is not an inhibitor or inducer of cytochrome P450 enzymes or common drug transporters. Therefore, LEQVIO® is not expected to have clinically significant interactions with other medicinal products. Based on the limited data available, clinically meaningful interactions with atorvastatin, rosuvastatin or other statins are not expected.
Fertility, pregnancy and lactation1
Pregnancy:
There are no or limited data on the use of LEQVIO® in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
As a precautionary measure, it is preferable to avoid the use of LEQVIO® during pregnancy.
Breast-feeding:
It is unknown whether LEQVIO® is excreted in human milk. Available pharmacodynamic/toxicology data in animals have shown excretion of LEQVIO® in milk. A risk to newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from LEQVIO® therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility:
No data on the effect of LEQVIO® on human fertility are available. Animal studies did not show any effects on fertility.
Learn more about LEQVIO®
Visit the Dosing and administration page for LEQVIO® or download the guide below:
*ORION-10 (N=1561) was a multicentre, double-blind, randomised, placebo-controlled 18-month clinical trial. Patients were randomised (1:1) to receive subcutaneous injections of LEQVIO® (284 mg) or matching placebo on top of a maximally tolerated statin and/or other lipid-lowering therapy. Each patient received four injections of LEQVIO® or placebo. After the first injection (Day 1), patients returned on Day 90, Day 270 and Day 450 to receive subsequent doses of LEQVIO® or placebo. Patients also attended the clinic on Days 30, 150, 330 and 510 for follow-up and limited laboratory assessments. The end-of-trial visit was conducted on Day 540. ASCVD risk equivalents included type 2 diabetes, HeFH or a 10-year risk of a cardiovascular event of ≥20% as assessed by the Framingham Risk Score for Cardiovascular Disease or equivalent.2
†Data from the ORION-8 open-label extension, a pooled cohort of 3274 patients treated with LEQVIO® with an assumed dosing frequency of two injections per year and an average treatment duration of 3.7 years.4
‡The exploratory cardiovascular endpoint comprised a Medical Dictionary for Regulatory Activities defined cardiovascular basket of non-adjudicated terms, including those classified within cardiac death and any signs or symptoms of cardiac arrest, nonfatal myocardial infarction or stroke.2
§Injection-site adverse events included preferred terms injection-site erythema, injection-site hypersensitivity, injection-site pruritus, injection-site rash and injection-site reaction.2
¶Shown are events occurring with a frequency of 5% or more in either the LEQVIO® group or the placebo group. A dash indicates that the frequency was less than 5%.2
ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; COVID-19, coronovirus disease 2019; HeFH, heterozygous familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol, PCSK9, proprotein convertase subtilisin/kexin type 9; SmPC, summary of product characteristics; ULN, upper limit of normal.
References
LEQVIO® Summary of Product Characteristics.
Ray KK, et al. N Engl J Med 2020;382:1507–1519.
Landmesser U, et al. Eur Heart J 2025:ehaf68.
Wright RS, et al. Cardiovasc Res 2024;120:1400–1410.
LEQVIO® and the LEQVIO® logo are registered trademarks of Novartis AG. Licensed from Alnylam Pharmaceuticals, Inc.
UK | April 2026 | FA-11561370-1
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.
