Prescribing information



Inclisiran is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • 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.1


Shining a light on the NHS’ ongoing battle against CVDwatch the video


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

Inclisiran is an innovative LDL-C-lowering therapy1,3

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Inclisiran has been identified by NHSEI as a medicine that it wishes to adopt systematically and at scale to help tackle lipid management in a large high-risk patient population. A collaboration between Novartis and NHS England delivered by the AAC and the AHSN Network uses a population health management approach to offer inclisiran treatment to at-risk ASCVD patients in primary care4

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Inclisiran delivered effective and sustained LDL-C reduction, in combination with a maximally tolerated statin, in patients with ASCVD (or risk equivalents)‡§2

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Inclisiran was generally well-tolerated in three Phase III trials, with a safety profile similar to placebo apart from injection-site reactions, which were more common in the inclisiran group2,5

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For further information please refer to the Summary of Product Characteristics by clicking here.


‡ At Month 17, inclisiran delivered placebo-corrected LDL-C reductions of 52%, as compared with baseline (95% CI: −55.7 to −48.8; P<0.0001) in ORION-10, and of 50%, as compared with baseline (95% CI: −53.1 to −46.6; P<0.0001) in ORION-11, with respective time-adjusted LDL-C reductions of 54% (95% CI: −56.2 to −51.3; P<0.0001) and of 49% (95% CI: −51.6 to −46.8; P<0.0001) from baseline between Months 3 and 18 relative to placebo.1,2
§ ASCVD was defined as coronary heart disease, cerebrovascular disease or peripheral arterial disease.6 ASCVD risk equivalents included type 2 diabetes, FH, or a 10-year risk of a cardiovascular event of ≥20% as assessed by the Framingham Risk Score for Cardiovascular Disease or equivalent.2

AAC Accelerated Access Collaborative; AHSN Academic Health Science Networks; ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; FH, familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol; NHS, National Health Service; NHSEI NHS England and NHS Improvement; siRNA, small interfering ribonucleic acid.


  1. Leqvio® Summary of Product Characteristics.
  2. Ray KK et al. N Engl J Med 2020;[382(16):1507–1519.]
  3. Lamb YN. Drugs 2021;81(3):389-395.
  4. New heart disease drug to be made available for NHS patients. Available at: [Accessed: January 2021].
  5. Raal FJ et al. N Engl J Med 2020;382(16):1520–1530.
  6. Ray KK et al. N Engl J Med 2020;382(16):1507–1519 (trial protocols).
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UK | March 2022 | 192714

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Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Novartis via or online through the pharmacovigilance intake (PVI) tool at
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at