What is the generic name?

EXENATIDE

What is the Trade Name for EXENATIDE?

BYDUREON BCise

What are the Indications for EXENATIDE?

• 1 INDICATIONS AND USAGE BYDUREON BCISE is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus [see Clinical Studies (14) ] . Limitations of Use ‚Ä¢ BYDUREON BCISE is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rat thyroid C-cell tumor findings to humans [see Warnings and Precautions (5.1) ] . ‚Ä¢ BYDUREON BCISE is not indicated for use in patients with type 1 diabetes mellitus. ‚Ä¢ BYDUREON BCISE is an extended-release formulation of exenatide and should not be used with other products containing the active ingredient exenatide. ‚Ä¢ BYDUREON BCISE has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis [see Warnings and Precautions (5.2) and Adverse Reactions (6.3) ] . BYDUREON BCISE is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. ( 1 ) Limitations of Use: ‚Ä¢ Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. (1) ‚Ä¢ Should not be used to treat type 1 diabetes. (1) ‚Ä¢ BYDUREON BCISE is an extended-release formulation of exenatide. Do not coadminister with other exenatide-containing products. (1) ‚Ä¢ Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. ( 1 , 5.2 )

References: https://open.fda.gov/