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 VICTOZA® REMS is to inform healthcare 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 VICTOZA® 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 VICTOZA® have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and VICTOZA® 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 VICTOZA®
- In clinical trials studying VICTOZA®, there were more cases of pancreatitis in patients treated with VICTOZA® than in patients treated with comparators
Please see the non-promotional VICTOZA® REMS Factsheet for Prescribers, reviewed by the FDA, for further information on these risks.