DRONEDARONE TAB
Clinical Criteria Summary
Exclusion Criteria
- Recently decompensated heart failure (HF) requiring hospitalization or Class IV HF
- Permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored)
- Second or third-degree atrioventricular block, or sick sinus syndrome (except in conjunction with a pacemaker)
- Significant bradycardia (e.g., less than 50 beats per minute)
- Concomitant use of a strong CYP3A inhibitor
- Concomitant use of drugs or herbal products that prolong the QT interval and may induce Torsade de Pointes
- QTc Bazett greater than or equal to 500 milliseconds with appropriate correction for prolongation of QRS interval in patients with intraventricular conduction delay and ventricular pacing
- Uncorrected hypokalemia or hypomagnesemia
- Liver or lung toxicity related to the previous use of amiodarone
- Severe hepatic impairment (i.e., Child-Pugh Grade C or baseline liver function tests greater than 2 times upper limit normal)
- Pregnancy (i.e., known pregnancy or positive pregnancy test; Category X)
- Nursing mothers
Inclusion Criteria
- Restricted to VA / VA Community Care Cardiology provider or other locally designated provider for initial prescription
- Symptomatic recurrent paroxysmal or persistent atrial fibrillation documented by electrocardiogram (ECG) within the past 6 months, with a second ECG in sinus rhythm or pending cardioversion
- Intolerance (e.g., unmanageable significant adverse event), contraindication to, or ineffective therapy with at least one other antiarrhythmic agent used for the rhythm management of atrial fibrillation
- Female patients of child-bearing potential: pregnancy must be excluded prior to receiving dronedarone and patient provided counseling on use of an effective method of contraception and risks vs. benefits of taking dronedarone if patient were to become pregnant
Discontinuation Criteria
- Consider discontinuation if the patient does not experience adequate symptom control (e.g., no or inadequate change in frequency or duration of palpitations or irregular heartbeat; no or inadequate increase in time to recurrence atrial fibrillation or flutter)
- Discontinue in patients who develop permanent atrial fibrillation, unless cardioversion is planned
- Discontinue if cardioversion fails or is not planned