TIKOSYN 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 can cause serious ventricular arrhythmias, primarily torsades de pointes
type ventricular tachycardia, a polymorphic ventricular tachycardia associated with
QT interval prolongation. 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.
TIKOSYN is contraindicated in patients with congenital or acquired long QT syndromes,
severe renal impairment, 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, and megestrol.
The most common adverse events reported with a frequency of ≥5% were headache, chest
pain, dizziness, respiratory tract infection, dyspnea, and nausea.