Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 5/22/17

Saxenda (liraglutide) Injection REMS

Goal of the Saxenda (liraglutide) Injection REMS Program

The goal of the SAXENDA REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis (including necrotizing pancreatitis) associated with SAXENDA by:

• Informing healthcare providers about the potential risk of medullary thyroid carcinoma associated with SAXENDA

• Informing healthcare providers about the risk of acute pancreatitis (including necrotizing pancreatitis) associated with SAXENDA

REMS Elements

• Communication Plan

Open the Full REMS Notification

REMS Summary of Terms