Prescribing information

 

   

ENTRESTO is indicated in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction.1,2

For full safety information, please refer to the GB and NI Summary of Product Characteristics.1,2

 

Prescribe ENTRESTO first-line as recommended by the following national3,4 and international guidelines:5,6

CaReMe UK heart failure algorithm*3 recommends treatment with sacubitril/valsartan or ACEi or ARBs + beta blocker and an MRA as first-line treatment option for chronic HFrEF patients where ejection fraction is <35%

ARNI may be used first line as part of cornerstone HFrEF therapy with a BB, MRA and SGLT2i3 in the 2021 ESC Guidelines for the treatment of chronic HFrEF patients5

 

Sacubitril/valsartan is recommended as RAASi of choice when LVEF is <40% by Heart Failure Hub Scotland guidelines4

The 2022 ACC/AHA update recommends an ARNI as the preferred first-line treatment option for patients with NYHA II-III HFrEF6

Delve further into the CaReMe UK Partnership algorithm for optimisation of chronic HFrEF patients and first-line use of sacubitril/valsartan3

white arrow
 
 

Reduce the risk of death by starting with ENTRESTO and adding therapies subsequently7

Prescribing ENTRESTO as first choice helps to protect more moments that matter for patients and their loved ones, by improving limitations in physical and social activities and HRQoL in comparison to patients treated with enalapril.8,9

In HFrEF patients, drug combinations were more effective in reducing all-cause mortality than the same drugs administered individually.7,10

Subsequent addition of the 4 pillar approach resulted in a cumulative RR in all-cause mortality at 24 months§7

 

Bar chart representing the cumulative absolute risk reduction in all-cause mortality at 24 months. 26% absolute reduction with quadruple therapy approach.

Comparisons between drug classes should not be drawn.

This is a decision analytical model study applied on the total US eligible HF population (N=2.1m). The magnitude of mortality reduction for SGLT2i was determined from the DAPA-HF trial.

Treatment should not be initiated if the serum potassium level is >5.4 mmol/l.1

Use of sacubitril/valsartan may be associated with an increased risk of hyperkalaemia, although hypokalaemia may also occur. Monitoring of serum potassium is recommended, especially in patients who have risk factors such as renal impairment, diabetes mellitus or hypoaldosteronism or who are on a high potassium diet or on mineralocorticoid antagonists. If patients experience clinically significant hyperkalaemia adjustment of concomitant medicinal products, or temporary down–titration or discontinuation is recommended. If serum potassium level is >5.4 mmol/l discontinuation should be considered.1

 

See how starting with ENTRESTO is as simple as starting with an ACEi (enalapril)1,2,11

white arrow
 

ENTRESTO contains valsartan, and therefore should not be co-administered with another ARB-containing product. Stop using an ACE inhibitor for 36 hours before starting ENTRESTO.1,2

 

Summary of the safety profile

The most commonly reported adverse events (AEs) during treatment with ENTRESTO were hypotension (17.6%), hyperkalaemia (11.6%) and renal impairment (10.1%). Angioedema was reported in patients treated with sacubitril/valsartan (0.5%).1,2

Common AE:
Anaemia, hypokalaemia, hypoglycaemia, dizziness, headache, syncope, vertigo, orthostatic hypotension, cough, diarrhoea, nausea, gastritis, renal failure (renal failure, acute renal failure), fatigue, asthenia.1,2

Very common AE:
Hyperkalaemia, hypotension, renal impairment.1,2

Adverse reactions are ranked by System organ class and then by frequency with the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).

Please click here for safety information

 

*CaReMe UK Partnership is a collaboration between the British Cardiovascular Society, the Renal Association, the Association of British Clinical Diabetologists, the Primary Care Cardiovascular Society and the Primary Care Diabetes Society.
Measure serum sodium, 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.3
DISCLAIMER: This is a US guideline and should not be used to guide treatment decisions in the UK.
§Analysis of 2,132,800 patients with  HFrEF and NYHA class II-IV heart failure.

ACC, American College of Cardiology; ACEi, angiotensin-converting enzyme inhibitor; AE, adverse event; AHA, American Heart Association; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor neprilysin inhibitor; BB, beta blocker; CaReMe UK, Cardio-Renal-Metabolic Partnership UK; ESC, European Society of Cardiology; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; HRQoL, health-related quality of life; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; NYHA, New York Heart Association; RAASi, renin-angiotensin-aldosterone system inhibitor; RR, risk reduction; SGLT2i, sodium-glucose co-transporter-2 inhibitor.

References:

  1. ENTRESTO Summary of Product Characteristics. Electronic medicines compendium website, GB. Available at: https://www.medicines.org.uk/emc/product/7751/smpc. (Accessed May 2023).
  2. ENTRESTO Summary of Product Characteristics. Electronic medicines compendium website, NI. Available at: https://www.emcmedicines.com/en-gb/northernireland/medicine?id=a1393009-... (Accessed May 2023).
  3. CaReMe UK Partnership HF algorithm. Available at: https://www.britishcardiovascularsociety.org/__data/assets/powerpoint_doc/0021/61671/CaReMeUK-HF-October-2022.pptx. (Accessed May 2023).
  4. Heart Failure Hub Scotland guidelines. Available at: https://www.heartfailurehubscotland.co.uk/wp-content/uploads/2020/03/NHS-Scotland-Heart-Failure-Transition-and-Recovery-Plan-During-COVID-19-May-2020-Final.pdf (Accessed May 2023).
  5. McDonagh TE, et al. Eur Heart J 2021;42(36):3599–3726.
  6. Heidenreich P A, et al. Circulation 2022;145(18):e895–e1032.
  7. Bassi NS, et al. JAMA Cardiol 2020;5(8):948–951.
  8. Chandra A, et al. JAMA Cardiol 2018;3(6):498–505.
  9. Lewis EF, et al. Circ Heart Fail 2017;10(8):e003430.
  10. Burnett H, et al. Circ Heart Fail 2017;10(1):e003529.
  11. Enalapril Summary of Product Characteristics. Electronic medicines compendium website, UK. Available at: https://www.medicines.org.uk/emc/product/561/smpc. (Accessed May 2023).
Rate this content: 
Average: 4.3 (3 votes)
UK | May 2023 | 209756-3

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via uk.patientsafety@novartis.com or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at medinfo.uk@novartis.com