BYDUREON 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.

BYDUREON 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.

BYDUREON is not indicated for use in patients with type 1 diabetes mellitus.

BYDUREON is an extended-release formulation of exenatide and should not be used with other products containing the active ingredient exenatide.

BYDUREON has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. 

Based on postmarketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis.

Discontinue an immediate- or extended-release exenatide product prior to initiation of BYDUREON. Patients changing from immediate-release exenatide to BYDUREON may experience transient (approximately 2 to 4 weeks) elevations in blood glucose concentrations.

BYDUREON is contraindicated in patients with:

• A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• A prior serious hypersensitivity reaction to exenatide or to any of the excipients in BYDUREON. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with BYDUREON
• A history of drug-induced immune-mediated thrombocytopenia from exenatide products. Serious bleeding, which may be fatal, from drug-induced immune-mediated thrombocytopenia has been reported with exenatide use

Counsel patients regarding the potential risk of MTC with the use of BYDUREON and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) in patients treated with exenatide.

Patients receiving BYDUREON in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.

BYDUREON may induce nausea and vomiting with transient hypovolemia and may worsen renal function.

Exenatide has not been studied in patients with severe gastrointestinal disease, including gastroparesis. Because exenatide is commonly associated with gastrointestinal adverse reactions, including nausea, vomiting, and diarrhea, the use of BYDUREON is not recommended in patients with severe gastrointestinal disease.

Acute events of gallbladder disease have been reported in GLP-1 receptor agonist trials.

Patients may develop antibodies to exenatide following treatment with BYDUREON.

There have been postmarketing reports of serious injection-site reactions (e.g., abscess, cellulitis, and necrosis), with or without subcutaneous nodules, with the use of BYDUREON. Isolated cases required surgical intervention.

When initiating BYDUREON, consider reducing the dose of concomitantly administered insulin secretagogue or insulin to reduce the risk of hypoglycemia.

There have been postmarketing reports for exenatide of increased INR with concomitant use of warfarin, sometimes associated with bleeding.

Exenatide slows gastric emptying. Therefore, BYDUREON has the potential to reduce the rate of absorption of orally administered drugs.

Limited data with exenatide, the active ingredient in BYDUREON, in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Animal studies: adverse fetal and neonatal outcomes.

Exenatide, the active ingredient in BYDUREON, was present in the milk of lactating mice.

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• First-line therapy for patients inadequately controlled on diet and exercise. GoToSource

• Type 1 diabetes or diabetic ketoacidosis. GoToSource

• Use with insulin. GoToSource

• Dosage greater than 2 mg subcutaneous injection once every seven days. GoToSource

• Use in patients under 10 years of age. GoToSource

• Weight loss. GoToSource

• Excessive daytime sleepiness in patients with type 2 diabetes. GoToSource

• Adjunct therapy to primary percutaneous coronary intervention in patients with ST-segment-elevation myocardial infarction. GoToSource

• Psoriasis lesions in patients with type 2 diabetes. GoToSource 

• Parkinson’s disease. GoToSource

Acute pancreatitis (inflammation of the pancreas) including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. GoToSource 

Increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure. GoToSource  

Hypoglycemia (low blood sugar) and antibody development. GoToSource

Thyroid cancer. GoToSource

Gastroparesis (disorder that slows or stops the movement of food from the stomach to the small intestine). GoToSource

Lawsuits filed for pancreatitis and pancreatic cancer.