Risk Evaluation and Mitigation Strategy
Hypothetical patient portrayal
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 that are part of the REMS.