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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