Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Gattex (teduglutide [rDNA origin])

NDA #203441

REMS last update: 12/18/2018

Goals
Summary
REMS Materials
Update history

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

Take training provided by the REMS program.
Review the drug's Prescribing Information.
Review the following: Dear Healthcare Professional Letter, Prescriber Education Slide Deck, What You Need to Know about Gattex Treatment: A Patient and Caregiver Counseling Guide.
Report completion of training to the REMS Program via the REMS Website or the REMS Program Call Center.

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
Dear Healthcare Professional Letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_Dear_Healthcare_Professional_Letter.pdf
Prescriber Education Slide Deck (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_Prescriber_Education_Slide_Deck.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_REMS_Full.pdf
REMS Program Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_REMS_Program_Website_Screenshots.pdf
What You Need to Know About Gattex Treatment: A Patient and Caregiver Counseling Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Gattex_2018_12_18_What_You_Need_to_Know_About_Gattex_Treatment_A_Patient_and_Caregiver_Counseling_Guide.pdf

What updates have been made to the REMS?

Date	Summary of change
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: Change the sponsor contact information from NPS Pharmaceuticals, Inc. to Shire in the REMS appended materials. Update to the process change in adverse event reporting. Change the signatory on the Dear Healthcare Provider and Dear Professional Society letters.
06/26/2014	Modified to: Reflect the updated title of the patient and caregiver counseling guide in the the Dear Healthcare Professional and Dear Professional Society Letters. Reflect information from the completion of three major Gattex clinical trials to the Prescriber Education Slide Deck. Focus on the Gattex REMS key safety messages, and to provide for improved readability in the Patient and Caregiver Counseling Guide. Rename the Patient and Caregiver Counseling Guide to What You Need to Know About Gattex Treatment: A Patient and Caregiver Counseling Guide.
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.