Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 3/21/17

Gattex (teduglutide [rDNA origin]) Injection REMS

Goals of the Gattex (teduglutide [rDNA origin]) Injection REMS Program

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

REMS Elements

• Elements to Assure Safe Use

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REMS Summary of Terms