SAFETY & DOSING > Dosing

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ENTRESTO is available in 3 dosage strengths1

ENTRESTO is available in 3 dosage strengths

Pills shown not actual size.

How to prescribe ENTRESTO to your adult patients

Choose initial dose of ENTRESTO based on current treatment and titrate to the target dose1

SWITCHING FROM A LOWER DOSE OR NOT CURRENTLY ON AN ACEi OR ARB1:

SWITCHING FROM A LOWER DOSE OR NOT CURRENTLY ON AN ACEi OR ARB
  • Low-dose ACEi: total daily dose of ≤10 mg of enalapril or therapeutically equivalent dose of another ACEi (eg, lisinopril ≤10 mg; ramipril ≤5 mg)2

  • Low-dose ARB: total daily dose of ≤160 mg valsartan or therapeutically equivalent dose of another ARB (eg, losartan ≤50 mg; olmesartan ≤10 mg)2

SWITCHING FROM A HIGHER DOSE OF AN ACEi OR ARB1:

SWITCHING FROM A HIGHER DOSE OF AN ACEi OR ARB
  • High-dose ACEi: total daily dose of >10 mg of enalapril or therapeutically equivalent dose of another ACEi (eg, lisinopril >10 mg; ramipril >5 mg)2

  • High-dose ARB: total daily dose of >160 mg valsartan or therapeutically equivalent dose of another ARB (eg, losartan >50 mg; olmesartan >10 mg)2

  • ENTRESTO is contraindicated with concomitant use of an ACE inhibitor and in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy1

  • Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan1

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin ‖ receptor blocker.

Unless your patient is on a high ACEi/ARB dose, start ENTRESTO at 24/26 mg twice daily and double the dose every 2 to 4 weeks, as tolerated by the patient. When switching from ACEi, be sure to allow for a 36-hour washout period prior to initiating ENTRESTO.1

DOSING IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT

How to prescribe ENTRESTO for severe renal impairment (eGFR <30 mL/min/1.73 m2) or moderate hepatic impairment (Child-Pugh B classification)1

DOSING IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT
  • No starting dose adjustment is needed for mild or moderate renal impairment

  • No starting dose adjustment is needed for mild hepatic impairment. Use in patients with severe hepatic impairment is not recommended

  • ENTRESTO is contraindicated with concomitant use of an ACEi. Do not administer within 36 hours of switching from or to an ACEi

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* In PARAGON-HF, defined as LVEF ≥45% with structural heart disease (LAE or LVH); median LVEF was 57%. LVEF is a variable measure and the normal range can vary.1

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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.

IMPORTANT SAFETY INFORMATION

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

COLLAPSE

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.

IMPORTANT SAFETY INFORMATION

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. ENTRESTO is contraindicated in patients with a history of angioedema related to previous angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy.

ENTRESTO is contraindicated with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor. ENTRESTO is contraindicated with concomitant use of aliskiren in patients with diabetes.

Angioedema: ENTRESTO may cause angioedema. Angioedema associated with laryngeal edema may be fatal. ENTRESTO has been associated with a higher rate of angioedema in Black patients and in patients with a prior history of angioedema. ENTRESTO should not be used in patients with hereditary angioedema. If angioedema occurs, discontinue ENTRESTO immediately, provide appropriate therapy, and monitor for airway compromise. ENTRESTO must not be re-administered.

Hypotension: ENTRESTO lowers blood pressure and may cause symptomatic hypotension. Patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), are at greater risk. Correct volume or salt depletion prior to administration of ENTRESTO or start at a lower dose. If hypotension persists despite dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension (e.g., hypovolemia), reduce the dosage or temporarily discontinue ENTRESTO. Permanent discontinuation of therapy is usually not required.

Impaired Renal Function: Decreases in renal function may be anticipated in susceptible individuals treated with ENTRESTO. In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death. Closely monitor serum creatinine, and down-titrate or interrupt ENTRESTO in patients who develop a clinically significant decrease in renal function.

ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis. In patients with renal artery stenosis, monitor renal function. Avoid use with aliskiren in patients with renal impairment (eGFR <60 mL/min/1.73 m2).

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically.

Hyperkalemia: Hyperkalemia may occur with ENTRESTO. Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of ENTRESTO may be required.

Concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, may lead to increases in serum potassium.

ARBs: Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan.

Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with ENTRESTO.

Common Adverse Events: In a clinical trial of patients with heart failure with reduced ejection fraction, the most commonly observed adverse events with ENTRESTO vs enalapril, occurring at a frequency of at least 5% in either group, were hypotension (18%, 12%), hyperkalemia (12%, 14%), cough (9%, 13%), dizziness (6%, 5%), and renal failure/acute renal failure (5%, 5%). No new adverse reactions were identified in a trial of the remaining indicated population.

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References:

1. ENTRESTO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 2. Senni M, McMurray JJV, Wachter R, et al. Initiating sacubitril/valsartan (LCZ696) in heart failure: results of TITRATION, a double-blind, randomized comparison of two uptitration regimens. Eur J Heart Fail. 2016;18(9):1193-1202. doi:10.1002/ejhf.548

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