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Saxenda liraglutide (rDNA origin) injection

SAXENDA® REMS PROGRAM

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.

 

 

 

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