DOFETILIDE CAP,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Congenital or acquired long QT syndromes
- Baseline QT interval or QTc > 440 msec (or > 500 msec in patients with ventricular conduction abnormalities e.g., bundle branch blocks or intraventricular conduction delays)
- Severe renal impairment (calculated creatinine clearance per Cockcroft-Gault using actual body weight < 20 ml/min)
- Concomitant use with verapamil, cimetidine, trimethoprim (alone or in combination with sulfamethoxazole), ketoconazole, prochlorperazine, dolutegravir, megestrol, hydrochlorothiazide (alone or in combination with triamterene)
- Concomitant use with drugs that prolong the QT interval, or Class I or other Class III antiarrhythmic drug therapy
Inclusion Criteria
- Atrial fibrillation / atrial flutter (highly symptomatic) in patients who require cardioversion to normal sinus rhythm
- Maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/atrial flutter who have been converted to normal sinus rhythm
- Reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic due to risk of life-threatening ventricular arrhythmias
Provider & Initiation Restrictions
- Initial prescription restricted to VA / VA Community Care Cardiology provider or other locally designated provider
- Initiation, re-initiation, or dose increase restricted to inpatient admission for appropriate monitoring and dose adjustments
Monitoring & Dosing Requirements
- Place patient on telemetry
- Check baseline QTc (use QT interval if heart rate < 60 beats per minute)
- Calculate creatinine clearance using Cockcroft-Gault formula based on actual body weight and serum creatinine
- Initial dosing based on calculated CrCl: >60 ml/min (500 mcg twice daily), 40 to 60 ml/min (250 mcg twice daily), 20 to <40 ml/min (125 mcg twice daily)
- Check QTc 2 to 3 hours after first dose; continue current dose if increase <15%, decrease dose if increase >15% or is >500 msec
- Determine QTc at 2 to 3 hours after each subsequent in-hospital dose (doses 2 to 5)
- Discontinue dofetilide if QTc increases to >500 msec (or >550 msec with ventricular conduction abnormalities) after the second dose
- Continuous ECG monitoring required for minimum of 3 days, or minimum of 12 hours after electrical or pharmacologic conversion to normal sinus rhythm, whichever is longer
- Only one down titration suggested for QTc prolongation