SYMLIN REMS Purpose

The purpose of the SYMLIN REMS program is to inform health care providers about the following serious risks of SYMLIN:

  • Increased risk of severe hypoglycemia, particularly in patients with type 1 diabetes
  • Importance of insulin dose reduction

Counsel and instruct your patients on insulin dose reduction to minimize the risk of hypoglycemia.

  • Proper patient selection. SYMLIN is contraindicated in patients with any of the following:
    • Hypoglycemia unawareness
    • Confirmed gastroparesis
    • Serious hypersensitivity to SYMLIN or any of its product components

Please see the non promotional SYMLIN Factsheet, reviewed by the FDA, for more detailed safety information.

Risk Evaluation and Mitigation Strategy (REMS)

A 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 SYMLIN.