Effective August 26, 2026, the Risk Evaluation and Mitigation Strategy (REMS) for GATTEX (teduglutide) has been eliminated. The FDA determined that the Elements to Assure Safe Use are no longer necessary, and a REMS is no longer required to ensure that the benefits of GATTEX outweigh its risks. As a result, this program is no longer available.

Healthcare providers should continue to refer to the current GATTEX U.S. Prescribing Information (USPI) for important safety information and appropriate use of GATTEX, including monitoring recommendations.

Please click ‘Continue’ to be redirected to the GATTEX USPI.