Prescribing information

 

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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

 

Inclisiran is the first and only siRNA LDL-C-lowering therapy1,3,4

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Later this year, subject to a positive NICE appraisal, a proposed pioneering collaboration between Novartis and NHS England is set to use a population health approach to offer treatment to a large at-risk ASCVD patient population5

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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 group2,6

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

 

Inclisiran is not yet available to prescribe in the UK.

 

‡ 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.7 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

ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; FH, familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; siRNA, small interfering ribonucleic acid.

References

  1. Leqvio® Summary of Product Characteristics.
  2. Ray KK et al. N Engl J Med 2020;[382(16):1507–1519.]
  3. Stoekenbroek RM et al. Future Cardiol 2018;14(6):433–442.
  4. Klinovski M et al. CADTH Issues in Emerging Health Technologies, 2019. Canadian Agency for Drugs and Technologies in Health.
  5. Gov.uk. New heart disease drug to be made available for NHS patients. Available at: https://www.gov.uk/government/news/new-heart-disease-drug-to-be-made-ava... [Accessed: January 2021].
  6. Raal FJ et al. N Engl J Med 2020;382(16):1520–1530.
  7. Ray KK et al. N Engl J Med 2020;382(16):1507–1519 (trial protocols).
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UK | April 2021 | 104792
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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.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]