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1 Farydak rems program
2 Farydak rems
3 Farydak rems enrollment

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Website: Farydak-rems.com
Hostname: securabio.com
Region: CA
City: Culver City
Postal Code: 90232
Latitude: 34.020198822021
Longitude: -118.39279937744
Area Code: 310
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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.



part of the FARYDAK REMS program. Indication How can I minimize this risk? • Patient selection and evaluation o Do not start FARYDAK if patient has • Recent myocardial infarction • Unstable angina • QTcF >450 msec • Clinically significant ST-segment or T-wave abnormalities • Monitor ECG o Perform an ECG prior to start of therapy and


Approved Risk Evaluation and Mitigation Strategies (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. by informing healthcare providers about the risks of severe diarrhea and cardiac toxicities associated with FARYDAK.


I. Goal(s) II. REMS elements

FARYDAK REMS materials will be prominently displayed and disseminated at relevant scientific meetings where Novartis has a presence (e.g., booth) for the duration of the REMS. 5.



FDA-REQUIRED REMS* SAFETY INFORMATION Boxed Warning: Severe Diarrhea and Cardiac Toxicities with FARYDAK Treatment ©2015 Novartis 2/15 *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. www.FARYDAK-REMS.com for more information.


Novartis receives FDA approval of Farydak - multivu.com

Novartis receives FDA approval of Farydak ®, the first HDAC inhibitor for patients with multiple myeloma. Farydak, an HDAC inhibitor with epigenetic activity, approved in combination for patients who received at least two prior regimens including bortezomib and IMiD 1; Farydak prolonged median PFS benefit when used with bortezomib and dexamethasone combination versus combination alone (from 6


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