Risk Evaluation and Mitigation Strategies (REMS) Summary

Goal of the Ionsys (fentanyl iontophoretic transdermal system) REMS Program

The goal of the IONSYS REMS is to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed by:

• Ensuring dispensing to patients in certified hospitals only; and

• Informing healthcare providers of the serious risk of respiratory depression resulting from accidental exposure.

REMS Elements

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms