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Approved Risk Evaluation and Mitigation Strategies (REMS)

Farydak (panobinostat)
NDA #205353
REMS last update: 03/13/2020

What is the purpose of the REMS?

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

  1. by informing healthcare providers about the risks of severe diarrhea and cardiac toxicities associated with FARYDAK.

What do participants need to know?

Healthcare providers should read the relevant Medication Guide or communication materials included in the product-specific approved REMS to learn about the risk(s). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Farydak REMS, see the DailyMed link(s).
Material Name Material Name Link
Healthcare Provider Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020_03_13_Healthcare_Provider_Letter.pdf
Journal Information Piece (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020-03-13_Journal_Information_Piece.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020_03_13_REMS_Document.pdf
REMS Fact Sheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020_03_13_REMS_Fact_Sheet.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020-03-13_REMS_Full.pdf
REMS Website Screenshot (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Farydak_2020_03_13_REMS_Website_Screenshot.pdf

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
03/13/2020 Change in ownership
02/23/2015 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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