Prescribing information

 

   

Starting and monitoring patients on ENTRESTO is as simple as with ACEi (enalapril)1,2
 

Flexible starting doses tailored to your patients’ needs, with titration similar to ACEi (enalapril):1,2

 
Images of Entresto packaging Entresto 24/26 mg

ENTRESTO 24/26 mg

Images of Entresto packaging Entresto 49/51 mg

ENTRESTO 49/51 mg

Images of Entresto packaging Entresto 97/103 mg

ENTRESTO 97/103 mg

 
 

GO representing The starting dose is 24/26 mg or 49/51 mg twice daily, depending on the patient’s current treatment and medical condition.

The starting dose is 24/26 mg or 49/51 mg twice daily, depending on the patient’s current treatment and medical condition1

 

Image of a target, representing The target dose is 97/103 mg twice daily.

The target dose is 97/103 mg twice daily1

 

ENTRESTO contains valsartan and therefore should not be co-administered with another ARB-containing product.
Stop using an ACEi for 36 hours before starting ENTRESTO1

 

Prescribe ENTRESTO as your first choice with confidence1

In clinical trials, ENTRESTO generally demonstrated comparable safety and efficacy to ACEi (enalapril)1,3,4
 

Image of a house, representing PARADIGM-HF*: Most commonly reported AEs with Entresto were hypotension, hyperkalaemia and renal impairment.

PARADIGM-HF:* Most commonly reported AEs with ENTRESTO were hypotension, hyperkalaemia and renal impairment1,3

  • Fewer patients taking ENTRESTO discontinued therapy due to an AE during the double-blind period: 10.7% vs 12.3% with enalapril3
  • While more patients experienced symptomatic hypotension with ENTRESTO than with ACEi (enalapril), there was no increase in the rate of discontinuation due to hypotension-related effects (0.9% vs 0.7%; P=0.38)3
 

Image of a hospital, representing PIONEER-HF.

PIONEER-HF:

  • ENTRESTO showed significantly greater reductions in NT-proBNP and exploratory clinical outcomes, with comparable safety vs ACEi (enalapril), when initiated in hospital following haemodynamic stabilisation after an ADHF‡4
 

Download our clinical trial summaries for more information

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Dosing considerations:1

Standard dosing is indicated for patients: Low dosing is indicated for patients:
On a prior high dose of ACEi/ARBs Not receiving prior therapy with ACEi/ARB or on a low dose of ACEi/ARB
With mild renal impairment With moderate/severe renal impairment#
With mild liver impairment With SBP ≥100 to 110 mmHg
  With moderate liver impairment or with AST/ALT values more than twice the ULN**
 

The use of ENTRESTO may cause…

 

HYPOTENSION:
Temporary down-titration or discontinuation recommended. Consider other causes of hypotension††1

HYPOTENSION icon

 

RENAL FUNCTION:
Consider down-titration in clinically relevant cases1

RENAL FUNCTION icon

 
 

HYPERKALAEMIA:
Adjustment of concomitant medicinal products, temporary down-titration or discontinuation recommended. If serum K+ >5.4 mmol/L discontinuation should be considered1

HYPERKALAEMIA icon

 

ANGIOEDEMA:
Immediate discontinuation. Provide appropriate therapy and monitoring until resolution. ENTRESTO must not be readministered1

ANGIOEDEMA icon

 

starting warning icon

Do not initiate ENTRESTO in patients with SBP <100 mmHg or serum K+ levels >5.4 mmol/L1
Stop using an ACEi for 36 hours before starting ENTRESTO1

 

Newly diagnosed chronic HFrEF patient

newly diagnosed patient

Watch our patient identification video below to see which of your patients could benefit from ENTRESTO1

 

 

 

Learn more about how ENTRESTO can be used as your first choice in place of ACEi/ARB wherever your patients are in their HF journey1,3–13

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

Please click here for safety information

* PARADIGM-HF was a multinational, randomised, double-blind trial comparing ENTRESTO to enalapril in 8,442 symptomatic (NYHA Class II-IV) HFrEF patients (LVEF ≤40%, amended later to ≤35%). For the primary endpoint, composite of CV death or first HF hospitalisation, ENTRESTO was superior to enalapril (P<0.0001). The median follow-up duration was 27 months.3
† PIONEER-HF was a prospective, multicentre, double-blind, randomised, controlled trial designed to assess the safety, tolerability, and efficacy of in-hospital initiation of ENTRESTO compared with enalapril in 881 adult patients in the United States with HFrEF (EF ≤40% and NTproBNP ≥1600 pg/mL or BNP ≥400 pg/mL) stabilised during hospitalisation for ADHF. The primary endpoint was time-averaged proportional change in NT-proBNP from baseline through Weeks 4 and 8. An exploratory clinical endpoint was the outcome of a composite of serious clinical events, which included death, rehospitalisation for heart failure, implantation of a left ventricular assist device, and inclusion on the list of patients eligible for heart transplantation4
‡ Primary endpoint: Time-averaged proportional change in NT-proBNP concentration from baseline through Weeks 4 and 8.4
§ eGFR, urea, creatinine.
¶ E.g. potassium, sodium.
# Use with caution in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2).
** Moderate hepatic impairment: Child-Pugh B classification.
†† Dose adjustment of diuretics, concomitant antihypertensives and treatment of other causes of hypotension should be considered.
‡‡ An ACEi should be stopped for 36 hours before starting ENTRESTO®.1

ACEi, angiotensin-converting enzyme inhibitor; ADHF, acute decompensated heart failure; AE, adverse event; ALT, alanine aminotransferase; ARB, angiotensin receptor blocker; AST, aspartate aminotransferase; CV, cardiovascular; EF, ejection fraction; eGFR, estimated glomerular filtration rate; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; K+, potassium; LVEF, left ventricular ejection fraction; NT-proBNP, N-terminal-pro-brain natriuretic peptide; NYHA, New York Heart Association; SBP, systolic blood pressure; ULN, upper limit of normal.

References:

  1. ENTRESTO Summary of Product Characteristics. Electronic medicines compendium website, UK. Available at: https://www.medicines.org.uk/emc/product/7751/smpc. (Accessed September 2021).
  2. Enalapril Summary of Product Characteristics. Electronic medicines compendium website, UK. Available at: https://www.medicines.org.uk/emc/product/6105/smpc. (Accessed September 2021).
  3. McMurray JJ, et al. N Engl J Med 2014;371:993–1004.
  4. Velazquez EJ, et al. N Engl J Med 2019;380(6):539–548.
  5. Claggett B, et al. N Engl J Med 2015;373(23):2289–2290.
  6. Lewis EF, et al. Circ Heart Fail 2017;10(8):e003430.
  7. Solomon SD, et al. JACC Heart Fail 2016;4(10):816–822.
  8. Chandra A, et al. JAMA Cardiol 2018;3(6):498–505.
  9. Desai AS, et al. JAMA 2019;322(11):1077–1084.
  10. Wachter R, et al. Eur J Heart Fail 2019;21(8):998–1007.
  11. Januzzi JL Jr, et al. JAMA 2019;322(11):1085–1095.
  12. Maddox TM, et al. J Am Coll Cardiol 2021;77:772–810.
  13. CaReMe UK HF algorithm. Available at: https://www.britishcardiovascularsociety.org/__data/assets/powerpoint_do.... (Accessed September 2021).
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UK | October 2021 | 145885
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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 [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]