GATTEX REMS (Risk Evaluation and Mitigation Strategy)

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. The FDA has required a REMS for GATTEX.

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 education materials which are part of the REMS.  Post-training Knowledge Assessment Questions, which are not a part of the REMS, are provided to assure successful training before prescribing Gattex.

Follow the Two Step Process Below: