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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.
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).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
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:
Incorporating information about the new population, which expands usage to include pediatric patients 1 year of age and older with SBS who are dependent on parenteral support, into the existing REMS.
Making formatting and editorial changes, typographical corrections, and administrative changes throughout the REMS document and all REMS materials.
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.
