INCLISIRAN INJ,SOLN

Exclusion Criteria

• End-stage renal disease on dialysis
• Advanced heart failure with limited prognosis
• Severe comorbid non-cardiovascular condition that is expected to limit life expectancy
• Pregnancy or lactating
• Primary Inclusion Criteria (One must be met)
• History of ASCVD
• Severe hypercholesterolemia (e.g., HeFH, LDL-C > 190 mg/dL) without ASCVD
• Additional Inclusion Criteria (All must be met)
• Contraindication, intolerance to or insufficient LDL-C reduction with maximally tolerated dose of statin and needs further LDL-C lowering to reduce ASCVD risk consistent with established guidelines
• Contraindication, intolerance to or insufficient LDL-C reduction with ezetimibe and needs further LDL-C lowering to reduce ASCVD risk consistent with established guidelines
• Contraindication, intolerance to or insufficient LDL-C reduction with a monoclonal antibody inhibitor of PCSK9 and needs further LDL-C lowering to reduce ASCVD risk consistent with established guidelines
• Willing to return for subcutaneous administration of inclisiran by a healthcare provider at the initial visit, at 3 months and every 6 months thereafter
• Pregnancy Considerations (Select if applicable)
• Evaluate pregnancy status prior to initiating treatment since inclisiran may cause fetal harm
• Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy is recommended