Risk of Thyroid C-Cell Tumors

• Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether exenatide (Bydureon) causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies.
• Exenatide extended-release (Bydureon) is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with exenatide extended-release (Bydureon).
• Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications (4.1), Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)].
• The safety of BYDUREON, another formulation of exenatide extended-release, in pediatric patients age 10 to less than 18 years with type 2 diabetes was similar to that observed in the adults.