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FARYDAK® (panobinostat) Capsules

Risk Evaluation and Mitigation Strategy (REMS)

What is the FARYDAK REMS?

A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the FDA to manage known or potential serious risks associated with a drug product. The FDA has determined that a REMS is necessary to ensure that the benefits of FARYDAK® (panobinostat) outweigh the risks.

 

FARYDAK has a Boxed WARNING for the following risks:

Severe Diarrhea

  • Severe diarrhea occurred in 25% of FARYDAK-treated patients
    • Severe diarrhea is defined as ≥7 stools/day, IV fluids, or hospitalization
  • Diarrhea occurred in 68% of patients treated with FARYDAK compared with 42% in the control arm
  • Monitor for symptoms, institute anti-diarrheal treatment, interrupt FARYDAK, and then reduce dose or discontinue FARYDAK. Refer to the Fact Sheet for detailed diarrhea management information

Cardiac Toxicities

  • Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes occurred with FARYDAK
  • Cardiac ischemic events occurred in 4% of patients treated with FARYDAK, compared with 1% of patients in the control arm
  • Arrhythmias occurred in 12% of patients receiving FARYDAK, compared with 5% of patients in the control arm
  • Do not start FARYDAK if patient has
    • Recent myocardial infarction
    • Unstable angina
    • QTcF ≥450 msec
    • Clinically significant ST-segment or T-wave abnormalities