Entresto Prescribing Information

Sacubitril Valsartan (Entresto®) Prescribing Advice and Guidance
Therapeutic indication
Sacubitril Valsartan (Entresto®) is licensed for the treatment of symptomatic chronic heart failure in
adults with reduced ejection fraction.
Selection criteria
Patients should fit all of the following criteria:
 Symptomatic chronic heart failure, with
 New York Heart Association (NYHA) class II to IV symptoms, and
 a left ventricular ejection fraction of 35% or less on echocardiogram or equivalent function on
alternative imaging not older than 12 months, and
 On optimal medical therapy for HF including angiotensin-converting enzyme inhibitor (ACEI) or
angiotensin II receptor-blockers (ARB) (mandatory), beta-blocker and aldosterone antagonist
(spironolactone or eplerenone) for at least 3 months.
 Raised natriuretic peptides: BNP > 150pg/ml (NT-proBNP>600pg/ml) or if hospitalisation for
heart failure within the last 12 months, BNP>100pg/ml (NTproBNP>400pg/ml).
 Systolic blood pressure (SBP) ≥100 mmHg
 eGFR >30 ml/min/1.73 m2
 Serum potassium <5.4 mmol/l
Contra-indications
 Known history of angioedema related to previous ACEI or ARB therapy
 Hereditary or idiopathic angioedema
 Pregnancy
 Treatment should not be initiated in patients with serum potassium level >5.4 mmol/l or with
SBP <100 mmHg
 eGFR <30 ml/min/1.73 m2
 Severe hepatic impairment, biliary cirrhosis and cholestasis
 Sacubitril valsartan should not be co-administered with an ACEI or an ARB
 Concomitant use with aliskiren-containing medicinal products in patients with diabetes mellitus
or in patients with renal impairment (eGFR <60 ml/min/1.73 m2)
 Hypersensitivity to the active substances or to any of the excipients
Initiation and up-titration

 Initiation of sacubitril valsartan is to be undertaken under the supervision of a consultant with
an established expertise in managing patients with heart failure and access to a
multidisciplinary team.
 Sacubitril valsartan should not be co-administered with an ACEI or an ARB. Due to the potential
risk of angioedema when used concomitantly with an ACE inhibitor, it must not be started for at
least 36 hours after discontinuing ACE inhibitor therapy. For those taking an ARB, discontinue
ARB and start sacubitril valsartan at next scheduled dose of ARB.
 Initiation and titration to stable maintenance dose will be undertaken by the heart failure
specialist. It is estimated this may take up to 3 months.
 Starting dose and titration in those on established ACEI or ARB (after ceasing ACEI or ARB):
o Initiate 49mg/51mg sacubitril valsartan twice daily for 2-4 weeks then
o Increase to 97mg/103mg sacubitril valsartan twice daily thereafter
 Starting dose in those patients taking low ACEI or ARB dose:
Approved: September 2016 (Medicines Management Committee)

Review Date: September 2018
o Initiate 24mg/26mg sacubitril valsartan twice daily for 3-4 weeks then
o The dose should be doubled every 3-4 weeks to the target of 200 mg (97mg/103mg)
twice daily, as tolerated by the patient
 A starting dose of 24mg/26mg sacubitril valsartan should be considered in patients with
moderate renal impairment (eGFR 30-60 ml/min/1.73 m2).
 A starting dose of 24 mg/26 mg sacubitril valsartan twice daily should be considered for patients
with SBP ≥100 to 110 mmHg.
 Monitoring of renal function and blood pressure to be undertaken after each dose titration.
Down-titration or discontinuation
Adjustment of concomitant medicinal products, temporary down-titration or discontinuation of
sacubitril valsartan is recommended:
 If SBP <95 mmHg at follow up
 If symptomatic hypotension
 If eGFR decreases >35% at follow up
 If serum potassium >5.4 mmol/L at follow up
Maintenance and transfer to primary care

 Following titration to optimum tolerated dose, maintenance will be continued in primary care.
 Please ensure that previous ACEI or ARB treatment is removed from the repeat prescription
template and not continued.
 Ongoing monitoring of urea and electrolytes every 6 months for signs of renal impairment or
hyperkalaemia.
 Blood presssure should be monitored routinely.
Further prescribing information

 Please refer to the Summary of Product Characteristics (SPC) for further information regarding
side effects, drug interactions and special warnings:
http://www.medicines.org.uk/emc/medicine/31244
 Sacubitril Valsartan (Entresto®) has been approved by NICE (TA388):
https://www.nice.org.uk/guidance/ta388/resources/sacubitril-valsartan-for-treating-
symptomatic-chronic-heart-failure-with-reduced-ejection-fraction-82602856425157
Patient support and information

 A patient information leaflet will be offered to patients to support treatment initiation of
sacubitril valsartan therapy. Additionally, it will detail instructions to avoid concomitant ACEI or
ARB and confirm advice for patients during sick days.
 Novartis has developed a wallet sized card for patients to carry that can be shown to health care
professionals to alert them to the interactions of sacubitril valsartan and ACEI. The heart failure
specialist team will have access to this resource to provide to patients.
Primary care support

 GP to refer back to the specialist, who has initiated sacubitril valsartan if there are concerns
about contra-indications, cautions, monitoring results or prescribing responsibilities.
 Consultant contact details for advice and support:
-Dr Barbagallo email address: Rossella.Barbagallo@btuh.nhs.uk
- Dr Barbagallo’s secretary’s tel no (Jane Holliday): 01268 494332

References
 Chronic heart failure: Management of chronic heart failure in adults in primary and secondary
care. NICE clinical guideline 108 (2010).
 Ivabradine for treating chronic heart failure. NICE technology appraisal guidance no. 267 (2012).
 Implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias
and heart failure. NICE technology appraisal guidance no. 314 (2014)
 Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection
fraction. NICE technology appraisal guidance no. 388 (2016). www.nice.org.uk/guidance/ta388
 NICE Chronic Heart Failure Guidelines: www.nice.org.uk/guidance/cg108/evidence
 Ponikowski P, Voors AA, Anker SD et al. 2016 ESC Guidelines for the diagnosis and treatment of
acute and chronic heart failure, available at doi: 10.1093/eurheartj/ehw128
 McMurray JJV, Packer M, Desai AS et al. Angiotensin-neprilysin inhibition versus enalapril in
heart failure. N Eng J Med 2014; 371:993-1005.
 Summary of Product Characteristics, hip://www.medicines.org.uk/emc/medicine/31244
 North East and North Central London Position Statement: Sacubitril valsartan for HFrEFDate
released: June 2016
 Sacubitril Valsartan (Entresto®) Prescribing Pathway – Princess Alexandra Hospital,Harlow. Date
released: July 2016


Entresto Prescribing Information

Uploaded by

Copyright:

Available Formats

Entresto Prescribing Information

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Entresto Prescribing Information

Uploaded by

Copyright:

Available Formats

Sacubitril Valsartan (Entresto®) Prescribing Advice and Guidance

Initiation and up-titration

Approved: September 2016 (Medicines Management Committee)

Maintenance and transfer to primary care

Further prescribing information

Patient support and information

Primary care support

Approved: September 2016 (Medicines Management Committee)

Approved: September 2016 (Medicines Management Committee)

You might also like

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.