Approved Risk Evaluation and Mitigation Strategies (REMS)
Gattex (teduglutide [rDNA origin])
NDA #203441
REMS last update: 07/14/2020
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.
View application holder(s) REMS Website
Healthcare Providers who prescribe Gattex
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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 Gattex REMS, see the DailyMed link(s).Material Name | Material Name Link |
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Dear Healthcare Professional Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_Dear_Healthcare_Professional_Letter.pdf |
Patient and Cargiver Counseling Guide (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_Patient_and_Caregiver_Counseling_Guide.pdf |
Post Training Knowledge Assessment Questions (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_Post_Training_Knowledge_Assessment_Questions.pdf |
Prescriber Education Slide Deck (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_Prescriber_Education_Slide_Deck.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_REMS_Full.pdf |
REMS Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2020_07_14_REMS_Website_Screenshots.pdf |
What updates have been made to the REMS?
Date | Summary of change |
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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.
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