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

The purpose of the XULTOPHY® 100/3.6 REMS is to inform healthcare providers about the following serious risks:

Potential Risk of Medullary Thyroid Carcinoma

  • Liraglutide, one of the components of XULTOPHY® 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether XULTOPHY® 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.
  • Cases of MTC in patients treated with liraglutide have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and liraglutide use in humans.

Risk of Acute Pancreatitis

  • Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with liraglutide.

Please see the non-promotional XULTOPHY® 100/3.6 REMS Factsheet for Prescribers, reviewed by the FDA, for further information on these risks.