Approved Risk Evaluation and Mitigation Strategies (REMS)

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Farydak (panobinostat)
NDA #205353
REMS last update: 02/23/2015



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
FARYDAK REMS Website Landing Page Screenshot (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_REMS WEBSITE .pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_REMS DOCUMENT .pdf
REMS Factsheet (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_FACTSHEET .pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_FULL.pdf
REMS Letter for Professional Societies (print and email versions) (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_DEAR PROFESSIONAL SOCIETIES LETTER (PRINT AND EMAIL VERSIONS) .pdf
REMS Letter to Healthcare Providers (print and email versions) (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_DEAR HEALTHCARE PROVIDER LETTER (PRINT AND EMAIL VERSIONS) .pdf
The Journal Information Piece (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/FARYDAK_2015-02-23_JOURNAL INFORMATION PIECE .pdf

What updates have been made to the REMS?

Date Summary of change
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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