Lead reviewer: Cardiovascular review group Approved by: Formulary Subgroup of NHS Highland ADTC
Date: March 2012 Review date: March 2013
Version: 1 Warning documents uncontrolled when printed
Highland Formulary
Dronedarone treatment protocol
Drug
Dronedarone 400mg tablets (Multaq®)
Indication
Maintenance of sinus rhythm in adult clinically stable patients with paroxysmal atrial fibrillation or
persistent atrial fibrillation after cardioversion. Treatment will be initiated in patients without heart
failure after other drugs have been considered.
Dosage
400mg twice daily, with morning and evening meals.
Initiation and maintenance of treatment – delineation of responsibilities
Initiation - Treatment will be initiated by a consultant cardiologist
Before treatment is started, the consultant will record an ECG and serum creatinine, potassium
and magnesium, and LFTs.
Treatment with Class I or III antiarrhythmics (such as flecainide, propafenone, quinidine,
disopyramide, dofetilide, sotalol, amiodarone) will be stopped before starting dronedarone.
The consultant is responsible for ensuring that there are no contra-indications or clinically
significant drug interactions when treatment with dronedarone is started.
The consultant will inform the patient of the monitoring that the GP will carry out and of any
symptoms that should be reported to the GP (see below).
Continuation of treatment - GP’s responsibilities
Measure LFTs
• monthly for the first 6 months of treatment
• then at months 9 and 12
• every 6 months thereafter.
If alanine transaminase (ALT) levels are elevated to ≥ 3 times upper limit of normal (ULN), retest
within 48 to72 hours. If ALT levels are confirmed to be ≥ 3 times ULN after retesting, withdraw
dronedarone treatment.
As previously advised by the consultant, the GP will advise patients to report any of the following
symptoms immediately:
• symptoms of potential liver injury such as sustained new onset abdominal pain, anorexia,
nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine or itching
• symptoms of heart failure such as weight gain, dependent oedema or increased dyspnoea.
Note that dronedarone is a newly licensed medicine under intense monitoring by the MHRA. All
suspected adverse reactions to dronedarone should be reported to the MHRA via the Yellow Card
Scheme at www.yellowcard.gov.uk.
