Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 9/20/15

Victoza (liraglutide) Injection REMS

Goal of the Victoza (liraglutide) Injection REMS Program

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

• Informing healthcare providers about the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis (including necrotizing pancreatitis) associated with VICTOZA.

REMS Elements

• Communication Plan

REMS Summary of Terms