Approved Risk Evaluation and Mitigation Strategies (REMS)

Gattex (teduglutide [rDNA origin])

NDA 203441
REMS last update: 10/21/2022

What is Gattex?

Why is Gattex required to have a REMS?

To inform prescribers and patients about the risks of possible acceleration of neoplastic growth and enhancement of colon polyp growth, gastrointestinal obstruction, and biliary and pancreatic disorders associated with GATTEX.

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.