BlackBoxRX
 
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Dofetilide

  • 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. For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION. TIKOSYN is available only to hospitals and prescribers who have received appropriate TIKOSYN dosing and treatment initiation education; see DOSAGE AND ADMINISTRATION.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Baseline and continuous ECG during therapy
  • Do not initiate if baseline QTc > 440 msec (500 msec in patients with ventricular conduction problems)
  • Do not initiate if heart rate < 60>
  • Baseline CCr determines initial dosage. Additional dosage adjustments determined by QTc changes
  • Re-evaluate renal function and QTc every 3 months or when medically needed

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Index to FDA Drug Safety Information

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Patient Medication Guide

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Dofetilide

Updated January 2018