ENTRESTO^® (sacubitril/valsartan) is indicated for the treatment of heart failure with reduced ejection fraction (HFrEF) in patients with NYHA Class II or III, to reduce the incidence of cardiovascular death and heart failure hospitalization.

ENTRESTO^® should be administered in combination with other heart failure therapies, in place of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB).

Please refer to the ENTRESTO^® Product Monograph at www.novartis.ca/EntrestoMonograph or here for important information regarding:

• • Caution in patients above 80 years of age and lack of established safety and efficacy in pediatric patients (<18 years of age).
• •

  The safety and efficacy of ENTRESTO^® in pediatric patients has not been established.

• •

  Contraindications regarding recent symptomatic hypotension, concomitant use with any drug formulation containing an ACEi, known history of angioedema related to previous ACEi or ARB therapy, history of hereditary or idiopathic angioedema, the concomitant use with aliskiren-containing drugs in patients with diabetes mellitus (Type 1 or 2) or moderate to severe renal impairment (i.e., eGFR <60 mL/min/1.73 m²), pregnancy and nursing women, and hypersensitivity to the active substance or any of the excipients.

• • The most serious warnings and precautions regarding the use of ARB in pregnancy, co-administration with ACEi and ARB treatments, NT-proBNP monitoring, and co-administration with medications known to raise potassium levels.
• • Other relevant warnings and precautions regarding co-administration with drugs containing an ARB or renin inhibitor, history of angioedema, symptomatic hypotension, hyperkalemia, decreases in renal function in susceptible individuals, patients with renal arterial stenosis, woman of child-bearing potential or those currently nursing a child, patients with severe hepatic impairment, and patients with severe renal impairment.
• • Conditions of clinical use, adverse reactions, drug interactions, and dosing instructions.

The Product Monograph is also available by calling 1-800-363-8883 or via medinfo.canada@novartis.com.