Risk Evaluation and Mitigation Strategy (REMS)

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.

Risks associated with Tikosyn and its authorized generic

In order for Pfizer to communicate certain risks about Tikosyn and its authorized generic, Pfizer has worked with the FDA to develop materials to communicate the risk of induced arrhythmia.

Tikosyn and its authorized generic are prescription medicines that contain dofetilide.

You must enroll in the Tikosyn and Authorized Generic REMS program to prescribe or dispense Tikosyn® or its authorized generic.

The goals of the REMS for Tikosyn and its authorized generic are to mitigate the risk of Tikosyn and its authorized generic induced arrhythmia by:

  • Ensuring that Tikosyn and its authorized generic are prescribed only by certified prescribers, and dispensed only by certified dispensers;
  • Educating health care providers about the risks and the need to initiate and re-initiate therapy in a health care facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation;
  • Informing patients about the serious risks associated with Tikosyn and its authorized generic therapy.