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.

 

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The 2024/2025 updates of QOF include two cholesterol indicators3

 

CHOL003

Percentage of patients on the QOF Coronary Heart Disease, Peripheral Arterial Disease, Stroke/TIA or Chronic Kidney Disease Register who are currently prescribed a statin, or, where a statin is declined or clinically unsuitable, another lipid-lowering therapy3

CHOL004

Percentage of patients on the QOF Coronary Heart Disease, Peripheral Arterial Disease, or Stroke/TIA Register, who have a recording of LDL-C in the preceding 12 months that is 2.0 mmol/L or lower or where LDL-C is not recorded a recording of non-HDL-C in the preceding 12 months that is 2.6 mmol/L or lower3

Icon of an arrow in the centre of a target.

The 2024/2025 QOF reflects a continued commitment to the importance of cholesterol management in patients who have had a cardiovascular event; with a target of 2.0 LDL-C mmol/L in those who have a recording of LDL-C in the preceding 12 months3

Using LEQVIO® first when statins alone are not enough may help most patients achieve lower than the 2.0 mmol/L LDL-C QOF target*3,4

Findings from the ORION-8 open-label extension study in patients with ASCVD (or risk equivalents):†5

Icon of a calendar with the text '2 doses a year'

With two maintenance doses a year, almost 80% of ASCVD patients on LEQVIO® achieved LDL-C targets in combination with a maximally tolerated statin (baseline LDL-C of 2.92 mmol/L ±1.2).§5

After an initial dose, LEQVIO® is administered again at 3 months, followed by every 6 months.1,2

Icon of a shield.

With over 12,000 patient-years exposure and >20,000 injections, the safety profile of LEQVIO® remains consistent, with no new safety signals identified.||5 

In clinical trials, LEQVIO ® had a safety profile similar to placebo, apart from injection-site reactions (8.2%)1,2

 

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Start LEQVIO® today and help your practice and secondary prevention patients achieve QOF LDL-C targets1–3

Understand which of your patients are to start LEQVIO®

The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been determined.1,2

*Data from the multicentre, double-blind, randomised, placebo-controlled, 18-month ORION-10 (N=1,561) and ORION-11 (N=1,617) clinical trials evaluating adult patients on a maximally tolerated statin with ASCVD, and with ASCVD or risk equivalents, respectively. The baseline mean (±) LDL-C levels were 2.70 ±1.02 mmol/L with LEQVIO® and 2.71 ±0.96 mmol/L with placebo in ORION-10, and 2.77 ±1.08 mmol/L with LEQVIO® and 2.68 ±0.94 mmol/L with placebo in ORION-11. 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 (OR 19.2;14.7–25.2), and 70% vs 13% in ORION-11 (OR 18.5;14.2–24.1).4
ORION-8 was a long-term extension study with up to 3 years of follow-up in patients (n=3,274) with ASCVD, ASCVD risk equivalent or HeFH who completed either the Phase II ORION-3 study or one of the three Phase III studies (ORION-9, ORION-10, or ORION-11). Primary endpoints were the proportion of patients achieving pre-specified LDL-C goals (ASCVD <1.8 mmol/L [<70 mg/dL]; ASCVD risk equivalent <2.6 mmol/L [<100 mg/dL]) at end of study and safety.5
§
(79.4%). Orion 8 (n=3,274) assessed the long-term efficacy and safety of LEQVIO® in patients who entered an open-label extension after completing either ORION-3, ORION-9, ORION-10 or ORION-11 trials. Patients had a baseline LDL-C of 2.92 mmol/L (± 1.2) and the primary endpoints were the proportion of patients achieving pre-specified LDL-C goals (ASCVD <1.8 mmol/L and ASCVD risk equivalent <2.6 mmol/L) at end of study, and safety. Mean cumulative exposure to LEQVIO® in ORION-8 was 3.7 years with a maximum of 6.8 years.5
||Data from the ORION-8 open-label extension, a pooled cohort of 3,274 patients treated with LEQVIO® with an assumed dosing frequency of two injections per year and an average treatment duration of 3.7 years, with a maximum of 6.8 years.5

ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; CVD, cardiovascular disease; HDL-C, high-density lipoprotein cholesterol; HeFH, heterozygous familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol; OR, odds ratio; QOF, quality and outcomes framework; TIA, transient ischaemic attack.

References

  1. LEQVIO® Great Britain. Summary of Product Characteristics.
  2. LEQVIO® Northern Ireland. Summary of Product Characteristics.
  3. National Health Service. Quality and Outcomes Framework guidance. Available at: https://www.england.nhs.uk/publication/quality-and-outcomes-framework-gu... [Accessed April 2024].
  4. Ray KK et al. N Engl J Med 2020;382(16):1507–1519 and supplementary appendix.
  5. Wright RS, et al. Oral presentation at ESC Congress 2023, August 28, 2023.

 

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

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UK | April 2024 | 423363

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]