1. Medicines
  2. Cardiology
  3. LEQVIO® (Inclisiran)
  4. Dosing & administration

Click here for Prescribing Information

Dosing & administration

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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

 

Leqvio® is a first-in-class LDL-C-lowering therapy,1-3 with 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

 

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

Leqvio® is not reimbursed in Ireland at this time.

 

 

 

Subcutaneous administration of Leqvio® :1

The recommended dose of inclisiran is 284 mg, administered via a single pre-filled syringe: as an initial dose, again at 3 months, followed by a dose 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 cirlce with text on it 'every 6 months' and purple injection icon at 9 months.

 

Grey box with two images of liver and kidneys with text next to it saying '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 patients1'.

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.1

 

* After an initial dose, inclisiran is administered again at 3 months, followed by every 6 months.1
† No data are available in patients with severe hepatic impairment. Inclisiran should be used with caution in these patients.1
‡ There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients. The effect of haemodialysis on inclisiran pharmacokinetics has not been studied. Haemodialysis should not be performed for at least 72 hours after inclisiran dosing.1

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

References

  1. Leqvio® Summary of Product Characteristics. Accessed August 2022 at www.ema.europe.eu

  2. Stoekenbroek RM et al. Future Cardiol 2018;14(6):433–442.

  3. Klinovski M et al. CADTH Issues in Emerging Health Technologies, 2019. Canadian Agency for Drugs and Technologies in Health.

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March 2023 | IE189355
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▼ This medicinal product is subject to additional monitoring. Reporting suspected adverse reactions of the medicinal product is important to Novartis and the HPRA. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported via HPRA Pharmacovigilance, website: www.hpra.ie. Adverse events could also be reported to Novartis preferably via www.report.novartis.com or by email: [email protected] or by calling 01 2080 612.