What is the Tikosyn REMS program?
Tikosyn (dofetilide) is dispensed through a Risk Evaluation and Mitigation Strategy (REMS) program. The program is designed to make sure dofetilide is started in a setting where required safety steps—especially kidney-function–based dosing and heart-rhythm monitoring—can be done. [1]
What does the REMS require when starting Tikosyn?
The REMS focuses on initiation and the early dosing period because the main safety risk is abnormal heart rhythm (including torsades de pointes). The program requires that prescribers and pharmacies follow the required process for starting the drug and monitoring patients during initiation, including baseline and follow-up heart-rate/ECG checks used to guide dosing. [1]
How do patients get Tikosyn under the REMS?
Patients typically must be started by a prescriber who participates in the REMS and then receive Tikosyn through participating pharmacies that can meet the program’s requirements for safe dispensing and initiation. The REMS setup means Tikosyn is not intended to be used like a standard outpatient prescription without the required initiation controls. [1]
Why is Tikosyn under REMS (what risk is it trying to reduce)?
Dofetilide has a known risk of causing serious ventricular arrhythmias if started or dosed incorrectly. The REMS aims to reduce that risk by requiring appropriate patient selection, dose determination (including creatinine clearance for kidney function), and monitoring during initiation. [1]
Who runs or oversees the Tikosyn REMS?
The program is part of the FDA REMS system and is administered according to the REMS requirements for Tikosyn. The REMS program structure determines which prescribers and pharmacies are authorized to dispense/start Tikosyn according to the approved safety plan. [1]
Where can I find the official Tikosyn REMS materials?
Official REMS information and program requirements are posted through FDA REMS resources. You can search for “Tikosyn REMS” on the FDA REMS website to find the current documentation and details for prescribers and pharmacies. [1]
Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm