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
In order for Pfizer to communicate certain risks about TIKOSYN, Pfizer has worked with the FDA to develop materials to communicate the risk of induced arrhythmia.
The goals of the REMS for TIKOSYN are to mitigate the risk of TIKOSYN induced arrhythmia by:
- Ensuring that TIKOSYN is prescribed only by certified prescribers, dispensed only by certified dispensers and dispensed for use only with documentation of safe use conditions;
- 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 therapy.