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Important Safety Information and Indication
IMPORTANT SAFETY INFORMATION
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. TIKOSYN is available only to hospitals and prescribers who have received appropriate TIKOSYN dosing and treatment initiation education.
TIKOSYN is contraindicated in patients with congenital or acquired long QT syndromes, a baseline QT interval or QTc >440 msec (500 msec in patients with ventricular conduction abnormalities), severe renal impairment (calculated creatinine clearance <20 mL/min), or known hypersensitivity to TIKOSYN.
TIKOSYN is also contraindicated with verapamil, hydrochlorothiazide (alone or in combination, such as with triamterene), and cation transport system inhibitors such as cimetidine, ketoconazole, trimethoprim (alone or in combination with sulfamethoxazole), prochlorperazine, megestrol, and dolutegravir because these drugs may cause an increase in dofetilide plasma concentration.
TIKOSYN can cause serious ventricular arrhythmias, primarily Torsade de Pointes type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. QT interval prolongation is directly related to dofetilide plasma concentrations. Factors such as reduced creatinine clearance or certain dofetilide drug interactions will increase dofetilide plasma concentration. The risk of TdP can be reduced by controlling the plasma concentration through adjustment of the initial dofetilide dose according to creatinine clearance and by monitoring the ECG for excessive increases in the QT interval. Calculation of creatinine clearance and QTc for all patients must precede administration of the first dose of TIKOSYN. Renal function and QTc should be re-evaluated every 3 months or as medically warranted.
The most common adverse events reported were headache, chest pain, dizziness, respiratory tract infection, dyspnea, and nausea.
TIKOSYN is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFL]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because TIKOSYN can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients.
TIKOSYN is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.
TIKOSYN has not been shown to be effective in patients with paroxysmal atrial fibrillation.
Please see full Prescribing Information, including BOXED WARNING , and Medication Guide .