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, patients and caregivers 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.