Download Eplerenone shared care guidelines

Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care
Eplerenone (Inspra®)
Shared Care Guideline for the use of eplerenone as an adjunct in left
ventricular dysfunction where there is evidence of heart failure after a
myocardial infarction.
This Guideline was originally produced in 2006 By Chris Lawson following consultation with specialists at
Barnsley Hospital. The Guideline has been updated by Caron Applebee (Prescribing Support Pharmacist) with
input from Gillian Smith (Medicines Information Pharmacist BHNFT) and the Cardiologists (Dr Tahir, Dr Etorki
and Dr Yousaf). This guideline has been subject to consultation and endorsement by:
 The Area Prescribing Committee on 12th December 2012.
 The LMC on 8th January 2013.
Introduction
Indication/Licensing information
 Eplerenone is licensed as an adjunct in left ventricular dysfunction in patients with evidence of heart failure
after a myocardial infarction.
Pharmacology
Eplerenone is a new treatment and is a selective aldosterone antagonist. Unlike spironolactone, eplerenone
blocks the mineralocorticoid receptor. Eplerenone has a similar incidence of gynaecomastea to placebo.
Compared to the incidence of gynaecomastea with high dose Spironolactone of approximately 10%.
Dosage and administration
Eplerenone is manufactured as 25mg and 50mg film coated tablets.
Eplerenone therapy should usually be started within 3-14 days after an acute MI. Treatment should be initiated
as 25mg once daily and titrated to the target dose of 50mg once daily, taking into account serum potassium.
Responsibilities of the specialist initiating treatment
Summary
 To assess the suitability of the patient for treatment and to confirm the diagnosis of heart failure.
 To discuss the benefits and side effects of treatment with the patient/carer and the need for long term
monitoring if applicable.
 To perform baseline tests and routine tests until the patient is stable. Serum Potassium will be monitored
prior to initiation of eplerenone and during the first few months of treatment (see over).
 To prescribe until the patient is stabilised on the maximum tolerated dose of eplerenone. The dose is
usually increased from 25mg od to 50mg od within 4 weeks of therapy but this may take longer..
 To explain shared care to the patient and gain acceptance from them
 To ask the GP whether they are willing to participate in shared care.
 To provide the GP with a summary of information relating to the individual patient to support the GP in
undertaking shared care (See Shared care request form in Appendix A).
 To advise the GP of any dosage adjustments required, monitoring required, when to refer back, and when
and how to stop treatment (if appropriate).
 To advise the GP when the patient will next be reviewed by the specialist.
 To monitor the patient for adverse events and report to the GP and where appropriate Commission on
Human Medicines/MHRA (Yellow card scheme).
 To provide the GP with contact details in case of queries.
 To review the patient if indicated or requested by the GP.
 To inform the GP if patient misses repeated follow up appointments.
Eplerenone Reduced Shared care Guideline
Date Prepared: September 2012
Review Date: September 2014
Page 1 of 5
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care
Baseline Tests
Serum Potassium
Routine Tests
Serum Potassium should be monitored:
 Prior to initiation of eplerenone
 Within one week of initiation
 One month after initiation
 Following any dose adjustment
 Every 3-6months, in respect of the patients response, as agreed with the specialist and/ or as
outlined in the product SPC.
This is especially important in elderly patients, patients with renal insufficiency and patients with
diabetes.
Regular and frequent monitoring or serum potassium is required in patients with mild to moderate
hepatic impairment.
Disease monitoring
Patients will be reviewed by Secondary Care within 3 months of discharge from hospital then every 4-6
months until the patient is stable.
Responsibilities of other prescribers
Acceptance of Responsibility by the Primary Care Clinician
It is optional for GPs to participate in taking on responsibility for shared care for the patient. GPs will take on
shared care only if they are willing and able.
Summary
 To reply to the request for shared care as soon as possible.
 To prescribe and adjust the dose as recommended by the specialist.
 To ensure there are no interactions with any other medications initiated in primary care.
 To continue monitoring as agreed with secondary care
 To refer back to the specialist where appropriate. For example:
o
Patient or general practitioner is not comfortable to continue with the existing regime due to either
change in condition or drug side effects.
o
Advice in respect of concordance.
o
Special situations, (e.g. Pregnancy)
 Discontinue the drug as directed by the specialist if required
 To identify adverse events if the patient presents with any signs and liaise with the hospital specialist
where necessary. To report adverse events to the specialist and where appropriate the Commission on
Human Medicines/MHRA (Yellow card scheme).
Eplerenone Reduced Shared care Guideline
Date Prepared: September 2012
Review Date: September 2014
Page 2 of 5
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care
Clinical Particulars
BNF therapeutic
class
2.2.3 Potassium-sparing diuretics and aldosterone antagonists
Cautions and
Contraindications
Contraindications:
 Hypersensitivity to eplerenone or any of the excipients
 Patients with serum potassium level > 5.0 mmol/L at initiation
 Patients with severe renal insufficiency (eGFR <30 mL per minute per 1.73 m 2)
 Patients with severe hepatic insufficiency
 Patients receiving potassium-sparing diuretics, potassium-supplements or strong
inhibitors of CYP 3A4 (eg itraconazole, ketoconazole, ritonavir, nelfinavir,
clarithromycin, telithromycin and nefazodone)
 The combination of an angiotensin converting enzyme (ACE) inhibitor and an
angiotensin receptor blocker (ARB) with eplerenone
Cautions:
 Increased risk of hyperkalaemia—close monitoring required; avoid if eGFR less
than 50 mL/minute/1.73 m2
Adverse Drug
Reactions
Monitoring
Interactions
Serum Potassium
(mmol/L)
<5.0
Action
5.0 to 5.4
Maintain
5.5 to 5.9
Decrease
Increase
Dose adjustment
(EOD = Every Other Day)
25mg EOD to 25mg OD
25mg OD to 50mg OD
No dose adjustment
50mg OD to 25mg OD
25mg OD to 25mg EOD
25mg EOD to withhold
> or = 6.0
Withhold
May restart 25mg EOD
if/when potassium
<5.0mmol/L
Diarrhoea, nausea; hypotension; dizziness; hyperkalaemia; rash; less commonly
flatulence, vomiting, atrial fibrillation, postural hypotension, arterial thrombosis,
dyslipidaemia, pharyngitis, headache, insomnia, gynaecomastia, pyelonephritis,
hyponatraemia, dehydration, eosinophilia, asthenia, malaise, back pain, leg cramps,
impaired renal function, azotaemia, sweating and pruritus
Serum potassium should be monitored closely.
 CYP3A4 inducers e.g. St John’s Wort
 CYP3A4 inhibitors e.g ketoconazole, itraconazole and clarithromycin. Dosing
should not exceed 25mg od
 Lithium cyclosporin and tacrolimus
 Potassium sparing diuretics and potassium supplements should not be coprescribed.
 ACE inhibitors and Angiotensin 2 antagonists
 Digoxin AUC increases by 16% when co-administered
 NSAID’s, ensure adequate hydration and close electrolyte monitoring
 Alpha 1 blockers ; monitor for postural hypotension
 TCA’s, neuroleptics, amifostine, bacofene; increased risk of postrural
hypotension
 Glucocorticoids; monitor for sodium and fluid retention leading to antagonising
antihypertensive effects.
 Warfarin; caution when dosing in upper limit
Consult BNF and/or product SPC for more information
Eplerenone Reduced Shared care Guideline
Date Prepared: September 2012
Review Date: September 2014
Page 3 of 5
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care
Communication
Specialist to GP
The specialist will inform the GP when they have initiated Eplerenone. When the patient is near completing
the satisfactory initiation period, the specialist will write to the GP to request they take over prescribing and
where possible give an indication as to the expected length of treatment. The Specialist will also send a
Shared care request form to support the GP in undertaking shared care. (Appendix A)
GP to specialist
If the GP has concerns over the prescribing of Eplerenone, they will contact the specialist as soon as possible.
Contact Details
Consultant Cardiologists
Telephone No
Fax No
Email
Dr M Tahir
01226 432572
01226 288614
[email protected]
Dr S Yousaf
01226 432572
01226 288614
[email protected]
Dr M Etorki
01226 432169
01226 288614
[email protected]
Medicines Information
01226 777875
01226 320425
[email protected]
References


BNF September 2012. Available at: www.bnf.org
SPC. Inspra®. Available at:
http://www.medicines.org.uk/EMC/medicine/16746/SPC/Inspra+25mg+%26+50+mg+filmcoated+tablets/ Accessed <24.9.12>
Eplerenone Reduced Shared care Guideline
Date Prepared: September 2012
Review Date: September 2014
Page 4 of 5
Reduced Shared Care Protocol –remains open to review in light of any new evidence
Amber with guidance (Amber-G) = To be initiated and titrated to a stable dose by a specialist prescriber with follow up
prescribing by primary care
Appendix A – Reduced Shared Care (Amber-G) request form



Specialist to complete when requesting GP to enter a shared care arrangement.
GP to return signed copy of form.
Both parties should retain a signed copy of the form in the patient’s record.
From (Specialist):
To (GP):
Patient details
Name:
ID Number:
Address:
DOB:
Diagnosis/Indication for Treatment:
Amber-G Drug details
Drug name:
Dose:
Date of initiation:
Length of treatment:
The patient will be reviewed by the Consultant on:
Telephone
for contact:
The patient number(s)
should be reviewed
by the GP by:
Monitoring: Serum Potassium every ___________ months
Consultant:
Date:
Communication
Consultant
Telephone number:
Fax number:
Email address:
Specialist Nurse
Telephone number:
Fax number:
Email address:
Confirmation of acceptance of shared care
Specialist name:
Specialist signature:
Date:
GP name:
GP signature:
Date:
Eplerenone Reduced Shared care Guideline
Date Prepared: September 2012
Review Date: September 2014
Page 5 of 5