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 SAXENDA® REMS is to inform health care providers about the following serious risks:
Potential Risk of Medullary Thyroid Carcinoma
- Liraglutide 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 SAXENDA® 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.
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.
- In clinical trials studying SAXENDA®, there were more cases of pancreatitis in patients treated with SAXENDA® than in patients treated with placebo.