Approved Risk Evaluation and Mitigation Strategies (REMS)

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Gattex (teduglutide [rDNA origin])
NDA #203441
REMS last update: 03/21/2017

View the Gattex Prescribing Information and Medication Guide at DailyMed.
View Gattex's Regulatory Information at Drugs@FDA

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 See Disclaimer page regarding links to external sites

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:


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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