Prescribing information

 

   

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The recommended starting dose of Entresto is one tablet of 49 mg/51 mg twice daily, doubling to one tablet of 97 mg/103 mg twice daily by weeks 2–4.

A starting dose of Entresto of 24 mg/26 mg twice daily and slow dose titration (doubling every 3-4 weeks) are recommended in patients not currently taking an ACEi or ARB or taking low doses of them.

 

 

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Entresto should not be initiated in patients with serum potassium level >5.4 mmol/l or with SBP <100 mmHg. A starting dose of 24 mg/26 mg twice daily should be considered for patients with SBP ≥100 to 110 mmHg.

 

 

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Entresto should not be co-administered with an ACEi or ARB. ACEi therapy should be discontinued for at least 36 hours prior to initiating Entresto.

 

 

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Entresto is contraindicated in patients with: a known history of angioedema related to previous ACEi or ARB therapy; hereditary or idiopathic angioedema; concomitant use of aliskiren-containing medicinal products in patients with diabetes mellitus or renal impairment (eGFR <60 ml/min/1.73 m2); severe hepatic impairment, biliary cirrhosis or cholestasis; or in the second or third trimester of pregnancy.

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If hypotension occurs, temporary down-titration or discontinuation of Entresto is recommended. Dose adjustment of diuretics, concomitant antihypertensives and treatment of other causes of hypotension should be considered.

 

 

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Use of Entresto may be associated with decreased renal function. Down-titration should be considered in patients who develop a clinically significant decrease in renal function.

 

 

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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.

 

 

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Angioedema has been reported in patients treated with Entresto. If it occurs, Entresto should be immediately discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms has occurred. Entresto must not be re-administered.

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Prior to initiation, consider concomitant medications/contraindications.

 

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Renal function, urea & electrolytes.

 

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Blood pressure.

 

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Ongoing review of medication throughout treatment.

Monitoring with Entresto is similar to that of an ACEi1–3

 

Please refer to the summary of product characteristics for further information.

 

Indication: Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.1

ACEi, angiotensin converting enzyme inhibitor; ARB, angiotensin II receptor blocker; eGFR, estimated glomerular filtration rate; SBP, systolic blood pressure.

References

  1. Entresto Summary of Product Characteristics, 2020.         
  2. Enalapril Summary of Product Characteristics, 2018.     
  3. NICE, 2018. Chronic heart failure in adults: diagnosis and management [NG106]. Available at: https://www.nice.org.uk/ guidance/ng106/evidence/full-guideline-pdf-6538850029 (Accessed January 2020).
ENT20-C046f(1) July 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://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]