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Important Safety Information

BOXED WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue ENTRESTO as soon as possible
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

ENTRESTO is contraindicated in patients with hypersensitivity to any component...

Indication

ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.

LVEF is a variable measure, so use clinical judgment in deciding whom to treat.

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Definitions  
ACEi, angiotensin-converting enzyme inhibitor; ADHF, acute decompensated heart failure; ARB, angiotensin II receptor blocker; ARR, absolute risk reduction; BP, blood pressure; CI, confidence interval; HR, hazard ratio; IV, intravenous; KM, Kaplan–Meier; LVEF, left ventricular ejection fraction; NNT, number needed to treat; NT-proBNP, N-terminal prohormone of brain natriuretic peptide; RRR, relative risk reduction.  

References  
1. Data on file. PARADIGM-HF and all-cause readmission analysis. Novartis Pharmaceuticals Corp; August 1, 2019.
2. Desai AS, Claggett BL, Packer M, et al; for the PARADIGM-HF Investigators. Influence of sacubitril/valsartan (LCZ696) on 30-day readmission after heart failure hospitalization. J Am Coll Cardiol. 2016;68(3):241-248.  
3. ENTRESTO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.
4. McMurray JJV, Packer M, Desai AS, et al; for the PARADIGM-HF Investigators and Committees. Angiotensin–neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993-1004. doi:10.1056/NEJMoa1409077
5. Velazquez EJ, Morrow DA, DeVore AD, et al. Angiotensin-neprilysin inhibition in acute decompensated heart failure [published correction appears in N Engl J Med. 2019;380(11):1090]. N Engl J Med. 2019;380(6):539-548. doi:10.1056/NEJMoa1812851