Prescribing information

ENTRESTO® (sacubitril/valsartan)

ENTRESTO is indicated in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF).²

For further information, please refer to the Entresto Summary of Product Characteristics.

Consider starting ENTRESTO as a first line option for patients living with chronic HFrEF as part of cornerstone treatment.^1,3,4

ARNI may be used as a first line option as part of cornerstone HFrEF therapy with a BB, MRA and SGTL2i in the 2021 ESC guidelines for the treatment of chronic HFrEF patients.^*3

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The recommended starting dose of ENTRESTO is one tablet of 49/51 mg twice daily. The dose should be doubled at 2-4 weeks to the target dose of one tablet of 97/103 mg twice daily, as tolerated by the patient.

In patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or taking low doses of these medicinal products, half of the starting dose is recommended.

If patients experience tolerability issues (systolic blood pressure [SBP] ≤95 mmHg, symptomatic hypotension, hyperkalaemia, renal dysfunction), adjustment of concomitant medicinal products, temporary down-titration or discontinuation of ENTRESTO is recommended. Please see the SmPC for full details.

ENTRESTO should not be co-administered with an ACEi or an ARB. Due to the potential risk of angioedema when used concomitantly with an ACEi, ENTRESTO must not be started for at least 36 hours after discontinuing ACEi therapy.

Please refer to the SmPC for the complete posology, including dose adjustments for certain populations.

^*ESC: ARNI may be used first line as part of cornerstone HFrEF therapy with a BB, MRA and SGLT2i for the treatment of chronic HFrEF patients.^3
†CaReMe UK: Sacubitril/valsartan is recommended as a first-line treatment option for chronic HFrEF where ejection fraction is <35%. Sacubitril/valsartan is to be given in combination with a BB and MRA. Measure serum sodium and potassium and assess renal function before and after starting, and after each dose increment. If eGFR is 30 to 45 ml/min/1.73 m², consider lower doses or slower titration of ACEi/ARBs/sacubitril/valsartan or MRAs. Half of the starting dose should be considered in patients with moderate renal impairment (eGFR 30-60 ml/min/1.73 m²).^1,3,4
‡ACC: ARNIs, ACEi or ARBs are recommended as first-line therapy in patients with HFrEF to reduce morbidity and mortality. If patients have chronic symptomatic HFrEF with NYHA class II or III symptoms and they tolerate an ACEi or ARB, they should be switched to an ARNi because of improvement in morbidity and mortality.^§4
§DISCLAIMER: This is a US guideline and should not be used to guide treatment decisions in the UK.

ACC, American College of Cardiology; ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor angiotensin receptor-neprilysin inhibitor; BB, beta-blocker; CaReMe UK, Cardio-Renal-Metabolic Partnership UK; ESC, European Society of Cardiology; HFrEF, heart failure with reduced ejection fraction; MoA, mode of action; MRA, mineralocorticoid receptor antagonist; NYHA, New York Heart Association; SGLT2i, sodium-glucose co-transporter 2 inhibitor.

References:

1. CaReMe UK HF algorithm. Available at: https://britishcardiovascularsociety.org.uk/ 

2. ENTRESTO (sacubitril/valsartan) Summary of Product Characteristics.

3. McDonagh TE, et al. Eur Heart J 2021;42(36):3599–3726.

4. Heidenreich PA, et al. Circulation 2022;145:e895–e1032.

5. McMurray JJV et al. N Engl J Med 2014;371(11):993-1004.

6. Enalapril SmPC. Available at https://www.medicines.org.uk/emc/product/561/smpc 

UK | April 2025 | FA-11282353