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FDA Date: 02/23/2015
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
• Communication Plan