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.2

 
 
 

Inclisiran was generally well-tolerated, with a safety profile similar to placebo apart from injection-site reactions1

Injection-site adverse reactions were more frequent with inclisiran than placebo, with between-group differences of 1.7% in ORION-10 and 4.2% in ORION-11; the majority of these reactions were mild, with none being severe or persistent.1

Discontinuation rates due to AEs were balanced among both treatment groups: 2.4% (n=19) vs 2.2% (n=17) in ORION-10 and 2.8% (n=23) vs 2.2% (n=18) in ORION-11, of patients treated with inclisiran and placebo, respectively.1

No clinically significant interactions with other medicinal products are expected with inclisiran.2 

Laboratory results with respect to liver and kidney function, levels of creatine kinase and high-sensitivity C-reactive protein, and platelet count were also similar in the inclisiran and placebo groups in each trial.

 

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Two maintenance doses a yearto lower LDL-C all year long1,2

Learn more about the dosing and administration of inclisiran.

 

 

The effect of inclisiran on cardiovascular morbidity and mortality has not yet been determined.2

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

 

Inclisiran is not yet available to prescribe in the UK.

 

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

AE, adverse event; ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; FH, familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol.

References

  1. Ray KK et al. N Engl J Med 2020;382(16):1507–1519.
  2. Leqvio® Summary of Product Characteristics.
  3. Ray KK et al. N Engl J Med 2020;382(16):1507–1519 (supplementary appendix). 
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UK | April 2021 | 106829
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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]