Dofetilide

FDA label

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Renal CrCl >60: 500 mcg BID; 40–60: 250 mcg BID; 20–<40: 125 mcg BID; <20 mL/min: contraindicated.

Hepatic Undefined

Individualize by CrCl and QTc; discontinue if QTc >500 msec (550 with ventricular conduction abnormalities).

Instructions

• Initiate/re-initiate only in a facility with continuous ECG monitoring for a minimum of 3 days
• Check baseline QTc/QT and calculated CrCl before first dose; recheck QTc/QT 2–3 h after each of the first 5 doses and adjust dose down for QT prolongation
• Maintain serum potassium within the normal range
• Do not double a missed dose — take the next dose at the usual time
• Re-evaluate renal function and QTc every 3 months

Contraindications

• Congenital or acquired long QT syndrome; baseline QTc/QT >440 msec (>500 with ventricular conduction abnormalities)
• Severe renal impairment (CrCl <20 mL/min)
• Concomitant verapamil, hydrochlorothiazide, or renal cation-transport inhibitors (cimetidine, trimethoprim, ketoconazole, prochlorperazine, dolutegravir, megestrol)

Cautions

• Torsade de Pointes / QT prolongation (dose-related)
• Hypokalemia and hypomagnesemia
• Ventricular arrhythmias and conduction disturbances

Adverse reactions

• Headache
• Chest pain
• Dizziness
• Respiratory tract infection
• Dyspnea, nausea
• Torsade de Pointes
• Ventricular tachycardia/fibrillation
• AV block

Pregnancy No adequate studies; animal teratogenicity (skeletal and visceral anomalies); use only if benefit justifies risk.

Lactation Undefined