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® to act directly on the heart and help improve cardiac function for your chronic HFrEF patients3

Watch the mechanism of action video below to gain a deeper understanding of ENTRESTO’s complementary actions1,2

Discover how ENTRESTO can improve the heart's structure and function vs baseline, and help reverse cardiac remodelling vs ACEi/ARBs3–5

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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

 

ACEi, angiotensin-converting enzyme inhibitor; AE, adverse event; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor neprilysin inhibitor; HFrEF, heart failure with reduced ejection fraction; RAAS, renin-angiotensin-aldosterone system.

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. Januzzi JL Jr, et al. JAMA 2019;322(11):1085–1095.
  4. Desai AS, et al. JAMA 2019;322(11):1077–1084.
  5. Wang Y, et al. J Am Heart Assoc 2019;8(13):e012272.
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UK | May 2023 | 145884-3

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 [email protected] 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 [email protected]