Dofetilide (Tikosyn) Considerations for Use*

US/FDA Approved Indications: Heart Rhythm Control for Atrial Fibrillation

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Black Box Warning* Available only to hospitals and prescribers who have received appropriate dosing and treatment initiation education. Must be initiated or re - initiated in a facility that can provide CrCl calculation, ECG monitoring, and cardiac resuscitation. Monitor on te lemetry for a minimum of 3 days.

Mechanism of Action

Prolongs cardiac repolarization (Class III antiarrhythmic properties).

Dosing

Cardioversion or maintenance: 125 to 500 mcg PO every 12 hrs, based on renal function and QTc interval.

Elderly: Initiate dosage at the lower end of the adult range

Hepatic Impairment: No dosage adjustment needed

Renal Impairment:
CrCl > 60 mL/min: 500 mcg twice daily
Cr Cl 40-60 mL/min: 250 mcg twice daily
Cr Cl 20- <40 mL min: 125 mcg twice daily
Cr Cl <20 mL/min: contraindicated

Contraindications
  • acquired/congenital QT prolongation
  • CrCl less than 20 mL/min
  • baseline QTc interval more than 440 msec or more than 500 msec in patients with ventricular conduction abnormalities
  • concomitant HCTZ, verapamil, cimetidine, ketoconazole, megestrol, prochlorperazine, or trimethoprim
  • Major Side Effects

    QT prolongation, torsades de pointes

    Dosage forms and Strengths

    PO: 125 mcg, 250 mcg, 500 mcg capsules

    Special Notes

    The patient must be registered to receive this drug; the hospital and pharmacy must be registered to stock this drug; the physician must be trained and registered to prescribe this drug.

    Adjust dose for renal function, age, body size, and QTc interval.

    Potassium and magnesium levels should be within normal range prior to initiating and during therapy.

    Must be initiated in the hospital. Monitor on telemetry at least 3 days.

    Has many potential drug interactions.

    Counseling

    Report signs/symptoms of angina or arrhythmias .

    Consult healthcare professional prior to using new drug (prescription, OTC, herbal) .

    * Refer to prescribing information for more complete information.
    †Dosages given in the table may differ from those recommended by the manufacturers.


    Sources:

    1. American College of Cardiology (ACC), American Heart Association (AHA), and the European Society of Cardiology (ESC). ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation. Washington, DC: American College of Cardiology.
    2. Heart Rhythm Society. AF360 Pocket Guide: Practical Rate and Rhythm Management of Atrial Fibrillation. 2010, Washington, DC: Heart Rhythm Society.
    3. Tarascon Pocket Pharmacopoeia® 2012.