Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 2/23/15

Farydak (panobinostat) REMS

Goal of the Farydak (panobinostat) REMS Program

The goal of the FARYDAK REMS is to mitigate the risks of severe diarrhea and cardiac toxicities (severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes) associated with FARYDAK treatment
• by informing healthcare providers about the risks of severe diarrhea and cardiac toxicities associated with FARYDAK

REMS Elements

• Communication Plan

Open the Full REMS Notification

REMS Summary of Terms