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.