Download Dronederone Shared Care Guideline - airedale

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
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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:
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Hypertension requiring drugs of at least two different classes
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Diabetes mellitus
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Previous TIA, stoke or systemic embolism
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Left atrial diameter of 50cm or greater
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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
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Aged 70 years or older
And
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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
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CONTRAINDICATIONS
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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
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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:
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Class I or III anti-arrhythmics e.g. flecainide, propafenone, disopyramide,
sotalol, amiodarone
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Potent cytochrome P 450 3A4 inhibitors e.g. ketoconazole, itraconazole,
clarithromycin
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Drugs inducing torsades de pointes e.g. phenothiazines, tricyclic
antidepressants, terfenadine and certain oral macrolides
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Grapefruit juice
Caution should be exercised in giving dronedarone to patients on:
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Digoxin (the dose of digoxin should be halved),
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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)
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Statins (lower starting dose and maintenance doses of statins should be
considered and patients monitored for clinical signs of muscular toxicity)
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Potent cytochrome P 450 3A4 inducers e.g. rifampicin, phenobarbital,
carbamazepine, phenytoin, St John's Wort
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Tacrolimus and sirolimus (dronedarone could increase their plasma
concentrations)
INITIAL SCREENING
PRESCRIBING
Patients receiving dronedarone should have their liver function monitored
before treatment.
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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
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Elderly- no dose adjustment necessary.
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Children and adolescents - not recommended.
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Hepatic impairment-contraindicated in patients with severe hepatic
impairment due to lack of data. No dose adjustment in mild to
moderate impairment.
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Renal impairment- contraindicated in patients with severe renal
impairment, no adjustment in other patients with renal impairment.
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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:
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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.
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The drug does not make a significant difference to the patient’s
symptoms.
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Patients develop any significant side-effects to the drug.
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Patients have a medical condition or state that contra-indicates using
this drug.
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If QTc Bazett interval 500 milliseconds
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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
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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.
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RESPONSIBILITY OF
THE SPECIALIST
INITIATING
TREATMENT
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RESPONSIBILITY OF
OTHER
PRESCRIBERS
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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