Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 7/27/15

Tanzeum (albiglutide) Injection REMS

Goal of the Tanzeum (albiglutide) Injection REMS Program

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

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

• Informing HCPs about the risk of acute pancreatitis associated with TANZEUM

REMS Elements

• Communication Plan

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REMS Summary of Terms