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:1,2

  • 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® is a first-in-class LDL-C-lowering therapy,1–4 with the convenience of

 

Box with title saying 'Inclisiran is a first-in-class LDL-C-lowering therapy,1-3 with convenience of'. Image of an injection.
  • HCP-administered
  • Subcutaneous injection
  • No refrigeration required
  • Fixed dose
  • No additional monitoring blood tests mandated
  • Does not add to pill burden
 

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

Beyond what is already clinically indicated for your patient.

Watch the short video below to learn more about LEQVIO® administration, including a step-by-step guide for injection. 

 

Subcutaneous administration of LEQVIO®:1,2

The recommended dose of LEQVIO® is 284 mg, administered via a single pre-filled syringe: initially, again at 3 months, and thereafter every 6 months.

 

Box with the title 'Subcutaneous administration of inclisiran'. Time line image with 2 blue injection icons stating the initial dose 0-3 month, purple circle with text on it 'every 6 months' and purple injection icon at 9 months.

LEQVIO® should be used with caution in patients with severe hepatic impairment and severe renal impairment.

For full information on LEQVIO® (inclisiran) dosing and administration, please refer to the SmPC.

Additional dosing and administration information1,2

Icon depicting liver and kidney

No dose adjustments are required for patients with mild or moderate hepatic impairment, mild, moderate or severe renal impairment or end-stage renal disease, or elderly patients.

Icon depicting a syringe

Check the LEQVIO® solution for injection visually before administration – it should be clear, colourless to pale yellow and essentially free of particles. If the solution contains visible particulate matter, the solution should not be used.

Icon depicting a syringe

LEQVIO® is administered by a healthcare professional into the abdomen, upper arm or thigh.

Icon of three images detailing injection sites

Icon depicting a syringe

Areas to avoid: active skin disease or injury (e.g. sunburns, skin rashes, inflammation, skin infections).

Icon depicting a syringe with a cross through

If a planned dose is missed by less than 3 months, LEQVIO® should be administered and dosing continued according to the patient's original schedule. If a planned dose is missed by more than 3 months, a new dosing schedule should be started – LEQVIO® should be administered initially, again at 3 months, followed by every 6 months.

For further information, please refer to the SmPC.

 

With over 12,000 patient-years exposure and >20,000 injections, the safety profile of LEQVIO® remains consistent, with no new safety signals identified in the ORION-8 open-label extension study‡5

 

Icon depicting 2x in a circle

With straightforward twice-yearly maintenance dosing, LEQVIO® can be administered during existing patient appointments1,2

Explore LEQVIO® eligibility criteria for and

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.5

HCP, healthcare professional; LDL-C, low-density lipoprotein cholesterol.

References

  1. LEQVIO® Great Britain. Summary of Product Characteristics.
  2. LEQVIO® Northern Ireland. Summary of Product Characteristics.
  3. Stoekenbroek RM, et al. Future Cardiol 2018;14(6):433–442.
  4. Klinovski M, et al. Inclisiran: a small interfering RNA molecule for treating hypercholesterolemia. Ottawa: CADTH; 2019. CADTH Issues in Emerging Health Technologies; Issue 180.
  5. Wright RS, et al. Oral presentation. ORION-8: Long-term efficacy and safety of twice-yearly inclisiran in high cardiovascular risk patients. ESC Congress 2023. Amsterdam, The Netherlands, 25–28 August 2023.

 

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

Rate this content: 
Average: 4.2 (5 votes)
UK | December 2023 | 301969

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 uk.patientsafety@novartis.com 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 medinfo.uk@novartis.com