Prescribing information

 

LEQVIO®▼ (inclisiran) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2,3

  • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach 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 GB and NI Summary of Product Characteristics.

 

LEQVIO®▼ (inclisiran) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2,3

  • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach 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 GB and NI Summary of Product Characteristics.

 

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The efficacy and safety profile of LEQVIO®, compared with placebo, was characterised in the ORION-10 and -11 studies in patients with ASCVD (or ASCVD risk equivalents).†1

Using LEQVIO® first when statins alone are not enough may help bring the 1.8 mmol/L LDL-C target within reach for most patients*1

After an initial dose, LEQVIO® is administered again at 3 months, followed by every 6 months.2,3

Using LEQVIO® first when statins alone are not enough may help bring the 1.8 mmol/L LDL-C target within reach for most patients*1

In clinical trials, LEQVIO® had a safety profile similar to placebo, apart from injection-site reactions.1–3

Adverse events across ORION-10 and ORION-11 trials:

LEQVIO® was generally well tolerated with a safety profile similar to placebo apart from injection-site reactions.1

Injection-site adverse reactions were more frequent with LEQVIO® than placebo:1

  • ORION-10: 2.6% (n=20) vs 0.9% (n=7), respectively
  • ORION-11: 4.7% (n=38) vs 0.5% (n=4), respectively

The majority of these reactions were mild, with none being severe or persistent:1

Discontinuation rates due to adverse events were balanced among both treatment groups:1

  • 2.4% (n=19) vs 2.2.% (n=17) in ORION-10, of patients treated with LEQVIO® and placebo, respectively
  • 2.8% (n=23) vs 2.2% (n=18) in ORION-11, of patients treated with LEQVIO® and placebo, respectively

Laboratory results were similar in the LEQVIO® and placebo groups in each trial:1

  • With respect to liver and kidney function, levels of creatine kinase and high-sensitivity C-reactive protein, and platelet count were also similar in the LEQVIO® and placebo groups in each trial

 

Icon depicting an arrow in a target

LDL-C lowering is key in patients who have already had a cardiovascular event – take advantage of their regular follow-up appointments and help get them to target4,5

 Learn how many patients reached the <1.8 mmol/L LDL-C target in ORION-8

The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been determined.2,3

*Data from the multicentre, double-blind, randomised, placebo-controlled, 18-month ORION-10 (N=1561) and ORION-11 (N=1617) clinical trials evaluating adult patients on a maximally tolerated statin with ASCVD, and with ASCVD or risk equivalents, respectively. The mean (±SD) LDL cholesterol levels at baseline in the ORION-10 and ORION-11 trials were 104.7±38.3 mg/dL (2.7±0.99 mmol/L) and 105.5±39.1 mg/dL (2.73±1.01 mmol/L), respectively. The proportion of patients achieving an LDL-C goal of 1.8 mmol/L at Month 17 with LEQVIO® vs placebo was 74% vs 15% in ORION-10 (19.2;14.7–25.2), and 81% vs 18% in ORION-11 (17.1;13.2–22.0). At Month 17, LEQVIO® delivered placebo-corrected LDL-C reductions of 52%, as compared with baseline (−51% with LEQVIO® vs +1% with placebo; 95% CI: −55.7 to −48.8; p<0.001) in ORION-10, and of 50%, as compared with baseline (−46% with LEQVIO® vs +4% with placebo; 95% CI: −53.1 to −46.6; p<0.001) in ORION-11, with respective time-adjusted LDL-C reductions of 54% (−51% with LEQVIO® vs +3% with placebo; 95% CI: −56.2 to −51.3; p<0.001) and of 49% (−46% with LEQVIO® vs +3% with placebo; 95% CI: −51.6 to −46.8; p<0.001) from baseline between Months 3 and 18 relative to placebo.1
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.1

ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; HDL, high-density-lipoprotein; HeFH, heterozygous familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol, PCSK9, proprotein convertase subtilisin/kexin type 9; QOF, Quality and Outcomes Framework; SD, standard deviation.

For ORION-10 and ORION-11 safety data, please click here.

References:

  1. Ray KK, et al. N Engl J Med 2020;382(16):1507–1519 and supplementary appendix.
  2. LEQVIO® Great Britain. Summary of Product Characteristics.
  3. LEQVIO® Northern Ireland. Summary of Product Characteristics
  4. Steen DL, et al. J Am Heart Assoc 2022;11(9):e022198.
  5. NHS England. Summary of national guidance for lipid management. Available at: https://www.england.nhs.uk/aac/wp-content/uploads/sites/50/2020/04/lipid... [Accessed October 2023].

LEQVIO® and the LEQVIO® logo are registered trademarks of Novartis AG. Licensed from Alnylam Pharmaceuticals, Inc.

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UK | November 2023 | 301967

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 via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]