FDA announced on March 9, 2016, the elimination of the Risk Evaluation and Mitigation Strategy (REMS) for Tikosyn (dofetilide) and its generic equivalent.
Tikosyn was approved on October 1, 1999 for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter) in patients with atrial fibrillation /atrial flutter of greater than one week duration who have been converted to normal sinus rhythm (NSR).
Tikosyn is also indicated for the conversion of atrial fibrillation and atrial flutter to NSR. Tikosyn can induce serious ventricular arrhythmias and its label describes the requirement to initiate the drug in an inpatient setting with appropriate monitoring and dose selection. Under the REMS program, Tikosyn (dofetilide) could only be prescribed by enrolled prescribers and dispensed by enrolled pharmacies and healthcare facilities.
In January 2016, the FDA determined that while safety risks for Tikosyn (dofetilide) still exist, the requirements of the REMS program are no longer necessary to ensure that the benefits of the drug outweigh the risks. The FDA reached this conclusion because REMS assessments have shown that prescribers have consistently demonstrated an understanding of the risks associated with Tikosyn. Additionally, the specific directions for initiating and monitoring Tikosyn have been incorporated into published clinical practice guidelines. Finally, other antiarrhythmic drugs with similar risks are available without a REMS program.
Prescribers should continue to follow the labeled directions for initiation and dose selection of Tikosyn in order to minimize the risk of induced ventricular arrhythmias.
By eliminating the Tikosyn REMS:
- Health care professionals who prescribe Tikosyn are no longer required to enroll in the Tikosyn and Authorized Generic REMS Program to prescribe or dispense Tikosyn or its authorized generic.
- Pharmacies and health care facilities may dispense Tikosyn or its authorized generic without having to enroll in the Tikosyn and Authorized Generic REMS Program.
- Pharmacies may dispense Tikosyn or its authorized generic without verifying that the prescriber is certified in the Tikosyn and Authorized Generic REMS Program.