FDA Modifies Tikosyn REMS Requirements

FDA Modifies Tikosyn REMS Requirements
FDA Modifies Tikosyn REMS Requirements

The Food and Drug Administration (FDA) announced changes to the Tikosyn (dofetilide; Pfizer) Risk Evaluation and Mitigation Strategies (REMS) program. 

As of July 8, 2015, the following have been removed from the Tikosyn REMS document and REMS appended materials:

  • The requirement for certified pharmacies to utilize a Tikosyn stamp
  • All references to the Tikosyn stamp, the phrase "...and dispensed for use only with documentation of safe use conditions"

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The REMS document has also been modified to clarify that the one-time recertification of prescribers and dispensers was required only after initial approval of the REMS. In order for healthcare providers to prescribe Tikosyn, they must complete and submit the Prescriber Certification Form. Prior to writing the first Tikosyn prescription for the patient, the healthcare provider must counsel the patient on the risk of induced arrhythmia, and blood lab measures and electrocardiogram (ECG) should be re-evaluated every three months. Patients must also be provided with the copy of the Medication Guide; if the patient is restarted on Tikosyn therapy, the patient must be provided with the Medication Guide.

Tikosyn is a Class III antiarrhythmic indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation or atrial flutter of >1 week duration who were converted to normal sinus rhythm (use only for highly symptomatic patients), and for conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.

For more information call (888) 463-6332 or visit FDA.gov.

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