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A FIRST-IN-CLASS siRNA
LDL-C–LOWERING THERAPY1

Mechanism of Action:
LEQVIO® is the first and only siRNA (small interfering RNA) therapy for LDL-C reduction that selectively targets the liver1

  • Works differently than other LDL-C–lowering treatments as a complement to statins1

  • Prevents the formation of the PCSK9 protein that promotes the degradation of LDL receptors1

  • Allows for greater uptake of LDL-C into hepatocytes1

  • Reaches undetectable levels in circulation within 48 hours of administration1

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LDL-C, low-density lipoprotein
cholesterol; RNA, ribonucleic acid.

INDICATION AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION
AND INDICATION

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INDICATION

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

Limitations of Use: The effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.

IMPORTANT SAFETY INFORMATION

Adverse reactions in clinical trials (≥3% of patients treated with LEQVIO and more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea.

Please click here for LEQVIO full Prescribing Information.

References: 1. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 2. Cubanski J, Damico A, Neuman T, Jacobson G. Sources of supplemental coverage among Medicare beneficiaries in 2016. KFF. November 28, 2018. Accessed November 5, 2021. https://www.kff.org/medicare/issue-brief/sources-of-supplemental-coverage-among-medicare-beneficiaries-in-2016/# 3. Ray KK, Landmesser U, Leiter LA, et al. Inclisiran in patients at high cardiovascular risk with elevated LDL cholesterol. N Engl J Med. 2017;376(15):1430-1440. doi:10.1056/NEJMoa1615758 4. Data on file. Novartis Pharmaceuticals Corp; 2019. 5. Grundy SM, Stone NJ, Bailey AL, et al. AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.0000000000000625 6. Data on file. Novartis Pharmaceuticals Corp; 2020. 7. Ray KK, Wright RS, Kallend D, et al; ORION-10 and ORION-11 Investigators. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387 8. European Medicines Agency. Annex I. Summary of Product Characteristics. Published December 9, 2020. Accessed August 4, 2022. https://www.ema.europa.eu/en/documents/product-information/leqvio-epar-product-information_en.pdf 9. McClellan M, Brown N, Califf RM, Warner JJ. Call to action: urgent challenges in cardiovascular disease: a presidential advisory from the American Heart Association. Circulation. 2019;139(9):e1-e11. doi:10.1161/CIR.0000000000000652 10. Jacobson TA, Cheeley MK, Jones PH, et al. The STatin Adverse Treatment Experience Survey: experience of patients reporting side effects of statin therapy. J Clin Lipidol. 2019; 13(3):415-424. 11. Jones PH, Nair R, Thakker KM. Prevalence of dyslipidemia and lipid goal attainment in statin-treated subjects from 3 data sources: a retrospective analysis. J Am Heart Assoc. 2012;1(6):1-10. doi:10.1161/JAHA.112.001800 12. Fox KM, Tai M-H, Kostev K, Hatz M, Qian Y, Laufs U. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018;107(5):380-388. doi:10.1007/s00392-017-1193-z 13. Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011–2012. J Clin Lipidol. 2016;10(5):1109-1118. doi:10.1016/j.jacl.2016.06.011 14. Data on file. ORION-3 (MDCO-PCS-16-01) ASCVD-only population. Novartis Pharmaceuticals Corp; 2022. 15. Ray KK, Troquay RPT, Visseren FLJ, et al. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated low-density lipoprotein cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Oral presentation at: American Heart Association (AHA) Scientific Sessions 2022; November 5-7, 2022; Chicago, IL.

IMPORTANT SAFETY INFORMATION

Adverse reactions in clinical trials (≥3% of patients treated with LEQVIO and more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea.

INDICATION

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

Limitations of Use: The effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.

Please click here for LEQVIO full Prescribing Information.

References: 1. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 2. Cubanski J, Damico A, Neuman T, Jacobson G. Sources of supplemental coverage among Medicare beneficiaries in 2016. KFF. November 28, 2018. Accessed November 5, 2021. https://www.kff.org/medicare/issue-brief/sources-of-supplemental-coverage-among-medicare-beneficiaries-in-2016/# 3. Ray KK, Landmesser U, Leiter LA, et al. Inclisiran in patients at high cardiovascular risk with elevated LDL cholesterol. N Engl J Med. 2017;376(15):1430-1440. doi:10.1056/NEJMoa1615758 4. Data on file. Novartis Pharmaceuticals Corp; 2019. 5. Grundy SM, Stone NJ, Bailey AL, et al. AHA/ACC/AACVPR/AAPA/ABC/ACPM/
ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.0000000000000625 6. Data on file. Novartis Pharmaceuticals Corp; 2020. 7. Ray KK, Wright RS, Kallend D, et al; ORION-10 and ORION-11 Investigators. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387 8. European Medicines Agency. Annex I. Summary of Product Characteristics. Published December 9, 2020. Accessed August 4, 2022. https://www.ema.europa.eu/en/documents/product-information/leqvio-epar-product-information_en.pdf 9. McClellan M, Brown N, Califf RM, Warner JJ. Call to action: urgent challenges in cardiovascular disease: a presidential advisory from the American Heart Association. Circulation. 2019;139(9):e1-e11. doi:10.1161/CIR.0000000000000652 10. Jacobson TA, Cheeley MK, Jones PH, et al. The STatin Adverse Treatment Experience Survey: experience of patients reporting side effects of statin therapy. J Clin Lipidol. 2019; 13(3):415-424. 11. Jones PH, Nair R, Thakker KM. Prevalence of dyslipidemia and lipid goal attainment in statin-treated subjects from 3 data sources: a retrospective analysis. J Am Heart Assoc. 2012;1(6):1-10. doi:10.1161/JAHA.112.001800 12. Fox KM, Tai M-H, Kostev K, Hatz M, Qian Y, Laufs U. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018;107(5):380-388. doi:10.1007/s00392-017-1193-z 13. Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011–2012. J Clin Lipidol. 2016;10(5):1109-1118. doi:10.1016/j.jacl.2016.06.011 14. Data on file. ORION-3 (MDCO-PCS-16-01) ASCVD-only population. Novartis Pharmaceuticals Corp; 2022. 15. Ray KK, Troquay RPT, Visseren FLJ, et al. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated low-density lipoprotein cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Oral presentation at: American Heart Association (AHA) Scientific Sessions 2022; November 5-7, 2022; Chicago, IL.