GATTEX REMS (Risk Evaluation and Mitigation Strategy)

A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug product.

The purpose of the GATTEX REMS is to inform healthcare providers and patients about the following risks:

  • Possible acceleration of neoplastic growth and Enhancement of colon polyp growth
  • Gastrointestinal obstruction
  • Biliary and pancreatic disorders

Prescribers who intend to treat patients with GATTEX should review the educational materials and complete the Post-Training Knowledge Assessment Questions.

Follow the Two Step Process Below: