Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 7/27/15

Trulicity (dulaglutide) Injection REMS

Goal of the Trulicity (dulaglutide) Injection REMS Program

The goal of the TRULICITY REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of pancreatitis associated with the use of TRULICITY by:

• Informing healthcare providers (HCPs) about the potential risk of medullary thyroid carcinoma associated with TRULICITY.
• Informing HCPs about the risk of pancreatitis associated with TRULICITY.

REMS Elements

• Communication Plan

Open the Full REMS Notification

REMS Summary of Terms