Approved Risk Evaluation and Mitigation Strategies (REMS)
Gattex (teduglutide [rDNA origin])
NDA #203441
REMS last update: 10/21/2022
What is the purpose of the REMS?
The goals of the GATTEX REMS are to mitigate the risks of possible acceleration of neoplastic growth and enhancement of colon polyp growth, gastrointestinal obstruction, and biliary and pancreatic disorders associated with GATTEX by:- Informing patients about the risks listed above associated with the use of GATTEX
- Informing healthcare providers about the risks listed above associated with GATTEX
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
What assessment is available to the REMS?
Assessment Plan |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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10/21/2022 | Revised to change the application holder's name. |
02/11/2021 | Modified the REMS website to add a link for prescriber re-training. |
07/14/2020 | Modified to add a link to the healthcare provider survey on the Gattex REMS website. |
05/16/2019 | Modified to align the REMS materials with the approval of efficacy supplement 13, including:
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12/18/2018 | Modified to align the REMS document and materials with labeling changes related to the approval of efficacy supplement 12. |
03/21/2017 | Modified to remove the communication plan as an element of the REMS and maintain the ongoing distribution of the DHCP Letters to prescribers identified as untrained as an activity under the elements to assure safe use. |
05/27/2016 | Modified to:
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06/26/2014 | Modified to:
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12/21/2012 | 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.