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DOCUMENT TITLE: DRONEDARONE TABLETS CARDIOLOGY SHARED CARE GUIDELINE FILENAME PHA_Medicines Management_Shared Care guidelines_Dronedarone VERSION № 2 DATE OF ISSUE May 2011 REVIEW INTERVAL 2 Year AUTHORISED BY Drug and Therapeutics Committee AUTHOR Dr A Zezulka - Consultant Cardiologist Dr R. Best – Locum Consultant Cardiologist Linda Stewart – Pharmacist EMAIL ADDRESS OF AUTHOR [email protected] COPY № 1 LOCATION OF COPIES 1. SHAREPOINT ASSOCIATED WORKING INSTRUCTIONS N/A LOCATION OF WORKING INSTRUCTIONS N/A TO BE VIEWED TRUST WIDE X PHARMACY ONLY DOCUMENT REVIEW HISTORY REVIEW DATE REVIEWED BY CHANGES 31/05/2013 Linda Stewart Review date extended. Sent to consultants for consultation 30/9/2013 Dr Smyllie – Consultant Cardiologist No changes required 17/12/2015 Dr Smylie – Consultant Cardiologist Dr Hanbali – Consultant Cardiologist Dr Best – Consultant Cardiologist Addition of MHRA alert recommendation on cardiac examinations and ECG monitoring 17/12//2017 NB: IF PRINTED, THIS BECOMES AN UNCONTROLLED DOCUMENT. ONLY THE SHAREPOINT VERSION IS VALID FOR OPERATIONAL USE. DRONEDARONE TABLETS CARDIOLOGY SHARED CARE GUIDELINE GENERAL STATEMENTS Dronedarone (Multaq®) should be initiated in secondary care under specialist supervision. Patient’s clinical condition is to be stable or predictable before contacting the GP to arrange shared care. The consultant should write to the GP to request the GP to participate in shared care. Agreement of GP must be sought before seeking patient agreement for shared care. Patients receive supplies of drug from hospital until shared care is agreed. The full summary of product characteristics (SPC) should be read before prescribing. PHARMACOLOGICAL SUMMARY Dronedarone is a multichannel blocker inhibiting the potassium currents and thus prolonging cardiac action potential and refractory periods (Class III). It also inhibits the sodium currents (Class Ib) and the calcium currents (Class IV). It non-competitively antagonises adrenergic activities (Class II). INDICATIONS FOR Dronedarone should only be initiated by Cardiologists for patients in whom amiodarone or other mainstream anti-arrhythmic drugs have not been tolerated, have been ineffective or are contraindicated. THERAPY Dronedarone is an anti-arrhythmic agent that is indicated as a second line treatment option for the treatment of non-permanent atrial fibrillation only in patients who have at least one of the following cardiovascular risk factors: Hypertension requiring drugs of at least two different classes Diabetes mellitus Previous TIA, stoke or systemic embolism Left atrial diameter of 50cm or greater Left ventricular ejection fraction less than 40%, but not recommended in patients with less than 35% because of limited experience of using it in this group Aged 70 years or older And Do not have unstable New York Heart Association (NYHA) class III or IV heart failure Prepared May 2011 Agreed by DTC May 2011 Reviewed November 2015 Review date November 2017 Page: 1 of 4 DRONEDARONE TABLETS CARDIOLOGY SHARED CARE GUIDELINE CONTRAINDICATIONS Breast feeding – it is not known whether dronedarone is excreted in human breast milk, it is best avoided in breast feeding women Unstable NYHA class III and IV heart failure Recent (1 to 3 months) stable NYHA class III heart failure or with left ventricular ejection fraction less than 35% QTc Bazett interval is 500 milliseconds Hypersensitivity to the active substance or any of the excipients Second- or third- degree Atrio-Ventricular block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker) Bradycardia <50 beats per minute Severe hepatic impairment Severe renal impairment (CrCl <30ml/min) History of, or current, heart failure or left ventricular failure Unstable haemodynamic conditions Permanent AF (i.e. duration > six month or unknown, and attempts to restore sinus rhythm no longer considered by physician) Lung and liver toxicity related to previous use of amiodarone Prepared May 2011 Agreed by DTC May 2011 Reviewed December 2015 Review date December 2017 Page: 2 of 2 DRONEDARONE TABLETS CARDIOLOGY SHARED CARE GUIDELINE CAUTIONS POTENTIAL DRUG INTERACTIONS Heart failure (avoid in patients with a recent history of moderate heart failure or with significantly reduced left ventricular function: Correct hypokalaemia and hypomagnesaemia before starting and during treatment. QT prolongation may occur with dronedarone follow up including ECG is recommended during treatment if QTc Bazett interval 500 milliseconds dronedarone should be stopped Dronedarone should not be given to patients on: Class I or III anti-arrhythmics e.g. flecainide, propafenone, disopyramide, sotalol, amiodarone Potent cytochrome P 450 3A4 inhibitors e.g. ketoconazole, itraconazole, clarithromycin Drugs inducing torsades de pointes e.g. phenothiazines, tricyclic antidepressants, terfenadine and certain oral macrolides Grapefruit juice Caution should be exercised in giving dronedarone to patients on: Digoxin (the dose of digoxin should be halved), Beta-blockers or calcium antagonists with depressant effects on sinus and atrio-ventricular nodes e.g. verapamil and diltiazem (these should be initiated at low dose and up-titration should be done only after ECG assessment) Statins (lower starting dose and maintenance doses of statins should be considered and patients monitored for clinical signs of muscular toxicity) Potent cytochrome P 450 3A4 inducers e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, St John's Wort Tacrolimus and sirolimus (dronedarone could increase their plasma concentrations) INITIAL SCREENING PRESCRIBING Patients receiving dronedarone should have their liver function monitored before treatment. The recommended adult dose is 400mg twice a day with breakfast and evening meal. Class 1 or III anti-arrhythmic treatment must be stopped before commencing dronedarone Elderly- no dose adjustment necessary. Children and adolescents - not recommended. Hepatic impairment-contraindicated in patients with severe hepatic impairment due to lack of data. No dose adjustment in mild to moderate impairment. Renal impairment- contraindicated in patients with severe renal impairment, no adjustment in other patients with renal impairment. Pregnancy- dronedarone is not recommended in pregnancy Prepared May 2011 Agreed by DTC May 2011 Reviewed December 2015 Review date December 2017 Page: 2 of 5 DRONEDARONE TABLETS CARDIOLOGY SHARED CARE GUIDELINE MONITORING Cardiovascular monitoring Patients should receive regular cardiac examinations, including an ECG at least every 6 months, to identify those who revert to AF. Discontinuation of dronedarone should be considered for these patients. Discontinue treatment if the patient develops permanent AF. Patients should be carefully evaluated for symptoms of heart failure during treatment. Patients should be appropriately anticoagulated as per clinical AF guidelines. International Normalised Ratio (INR) should be closely monitored after initiating dronedarone in patients taking vitamin K antagonists as per the prescribing information for these products. Hepatic monitoring Liver-function tests should be done: before starting treatment with dronedarone; after 1 week of treatment; after 1 month of treatment; then every month for 6 months; at month 9; at month 12; and periodically thereafter Renal monitoring Plasma creatinine values should be measured before and 7 days after initiation of dronedarone, and renal function should be monitored periodically afterwards. Discontinue treatment in any patients with further elevations of serum creatinine. Pulmonary monitoring Cases of interstitial lung disease, including pneumonitis and pulmonary fibrosis, have been reported in association with dronedarone. Onset of dyspnoea or non-productive cough may be related to pulmonary toxicity. If pulmonary toxicity is suspected during treatment, relevant lung examinations should be considered and treatment discontinued if confirmed. Patients receiving dronedarone should have their liver function monitored before treatment, monthly for 6 months, at 9 and 12 months and periodically thereafter. Measure serum creatinine 7 days after initiation. Cardiac examinations should be carried out regularly, including an ECG every 6 months to identify those who revert to AF. Patients should be evaluated for symptoms of heart failure during treatment. Patients should be evaluated for symptoms of pulmonary toxicity and if toxicity is suspected during treatment the relevant lung examinations should be considered. STOP (Dronedarone) & CONTACT AGH IF: If ALT levels are elevated to ≥ 3 x upper limit of normal, levels should be re-measured within 48 to 72 hours. If ALT levels are confirmed to be ≥ 3 x upper limit of normal after re-measurement dronedarone should be withdrawn. The drug does not make a significant difference to the patient’s symptoms. Patients develop any significant side-effects to the drug. Patients have a medical condition or state that contra-indicates using this drug. If QTc Bazett interval 500 milliseconds If patient has permanent atrial fibrillation Prepared May 2011 Agreed by DTC May 2011 Reviewed December 2015 Review date December 2017 Page: 3 of 5 DRONEDARONE TABLETS CARDIOLOGY SHARED CARE GUIDELINE ADVERSE EVENTS Very common side effects include changes in blood creatinine levels and changes in ECG Common side effects with dronedarone are; bradycardia, diarrhoea, vomiting, nausea, abdominal pains, dyspepsia, rashes pruritus, fatigue, asthenia. Less commonly dysgeusia, erythemas, eczema, photosensitivity reaction, dermatitis and allergic dermatitis. Increased blood creatinine levels and QTc Bazett prolonged Cases of liver injury, including two cases of liver failure requiring transplantation have been reported in patients receiving dronedarone. Some of these cases occurred early after start of treatment. Patients receiving dronedarone should have their liver function monitored before and during treatment. Additionally, patients should be advised to contact their healthcare professional if they experience any symptoms of liver injury. RESPONSIBILITY OF THE SPECIALIST INITIATING TREATMENT RESPONSIBILITY OF OTHER PRESCRIBERS Prescribing medication until maintenance regimen established. Evaluating any adverse events noted by GP or patient. Advising GP on change of, or discontinuation, of therapy. Discussion of risks and benefits of medication with patients and carers. Sexually active women of child bearing potential should be established on a contraceptive programme. Baseline monitoring of clinical parameters. Liaison with the general practitioner (GP) to share the patient’s care when a stable dose has been achieved and proven benefit has been established. Confirming with GP the use of the Shared Care Guideline. Evaluating adverse drug reactions (ADR’s) raised by the GP and evaluating any concerns arising from physical checks and reviews undertaken by GP. Advising GP on related issues such as drug interactions and use in pregnancy. Reply to the request for shared care as soon as practicable. Prescribe dronedarone once treatment regime has been stabilised. Monitor patient’s response to treatment and make dosage adjustments if agreed with specialist. Monitor liver function during treatment. Report to and seek advice from the specialist on any aspect of patient care that is of concern to the GP and may affect treatment. Continued discussion of risks and benefits with patients and carers as required. Continued monitoring as agreed with secondary care and referral back to secondary care if clinically indicated. Observing the patient for evidence of ADR’s or any abnormalities and raising with the secondary care clinician if necessary. Reducing and stopping treatment in line with secondary care clinician’s request. Prepared May 2011 Agreed by DTC May 2011 Reviewed December 2015 Review date December 2017 Page: 4 of 5 DRONEDARONE TABLETS CARDIOLOGY SHARED CARE GUIDELINE CONTACTS A patient information leaflet has been issued to your patient If any problems occur please contact: Consultant Cardiologist’s Secretary: 01535 292018 Pharmacy: 01535 293503 Access to shared care guidelines is available via the intranet at Airedale NHS Trust at: www.airedale-trust.nhs.uk/GPs/SharedGuide.html Prepared May 2011 Agreed by DTC May 2011 Reviewed December 2015 Review date December 2017 Page: 5 of 5