Confidence, Consensus & Continuation of Anti- Arrhythmic Drugs in ...

Dronedarone: Monitoring
Liver function is tested:
‣ before initiation of treatment and after one week
‣ on a monthly basis for six months
‣ at months 9 and 12 and then
‣ periodically thereafter
If alanine transaminase (ALT) levels are elevated ≥3 (upper limit of normal levels), then
the levels should be re-measured within 48-72 hours.
If ALT levels are confirmed to be ≥3 (upper limit of normal levels), after reassessment,
dronedarone treatment should be withdrawn.
Other monitoring requirements includes:
‣ Regular cardiac examinations including an ECG at least every 6 months
‣ INR closely monitored after initiating dronedarone in patients taking vitamin K
antagonists
‣ Plasma digoxin concentration, clinical and ECG monitoring if patient on digoxin
‣ Renal monitoring with plasma creatinine values measured prior to and 7 days after
initiation of dronedarone
‣ Pulmonary monitoring as onset of dyspnoea or non productive cough may be related
to pulmonary toxicity
‣ Grapefruit juice should not be taken with dronedarone.
‣ Co–administration with potent cytochrome P 450 (CYP) 3A4 inhibitors is
contraindicated e.g. ketoconazole, itraconazole, posaconazole and clarithromycin.