Banner background image Banner background image

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

MOA Video Thumbnail

THERE'S MORE TO KNOW ABOUT LEQVIO

Gain insights into
LEQVIO safety

SEE SAFETY PROFILE arrow

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

INDICATION AND IMPORTANT
SAFETY INFORMATION

COLLAPSE

EXPAND

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.

Adverse reactions led to discontinuation in 2.5% and 1.9% of LEQVIO- and placebo-treated patients, respectively. Discontinuation due to injection site reactions, which included injection site pain, erythema and rash, were 0.2% and 0% of LEQVIO- and placebo-treated patients, respectively.

Please click here for LEQVIO full Prescribing Information.

References: 1. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 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. AHN/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. 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 9. Jacobson T, 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(6):405-424. 10. Jones PH, Radhika N, 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 11. 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 12. 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

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.

Adverse reactions led to discontinuation in 2.5% and 1.9% of LEQVIO- and placebo-treated patients, respectively. Discontinuation due to injection site reactions, which included injection site pain, erythema and rash, were 0.2% and 0% of LEQVIO- placebo-treated patients, respectively.

Please click here for LEQVIO full Prescribing Information.

References: 1. LEQVIO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 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. AHN/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. 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 9. Jacobson T, 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(6):405-424. 10. Jones PH, Radhika N, 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 11. 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 12. 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