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