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 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.
 

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

 

Subcutaneous administration of inclisiran: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

 

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

 

Inclisiran is not yet available to prescribe in the UK.

 

* 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.

  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.

UK | April 2021 | 106831
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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]