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

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

Discontinue an immediate- or extended-release exenatide product prior to initiation of BYDUREON BCISE. Patients changing from another extended-release exenatide product to BYDUREON BCISE may do so at the next regularly scheduled dose. Patients changing from immediate-release exenatide to BYDUREON BCISE may experience transient (approximately 2 to 4 weeks) elevations in blood glucose concentrations. 

Prior treatment with an immediate- or extended-release exenatide product is not required when initiating BYDUREON BCISE therapy.

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.

BYDUREON BCISE is not a substitute for insulin. BYDUREON BCISE is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

Use with insulin has not been studied and is not recommended.

BYDUREON BCISE 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.

BYDUREON BCISE has not been studied in patients with acute or chronic hepatic impairment.

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 BYDUREON BCISE causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined.

BYDUREON BCISE 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 of BYDUREON BCISE. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with exenatide
• 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 for MTC with the use of BYDUREON BCISE and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with BYDUREON BCISE.

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

Do not administer BYDUREON BCISE intravenously or intramuscularly.

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 BCISE.

BYDUREON BCISE may induce nausea and vomiting with transient hypovolemia and may worsen renal function. There have been postmarketing reports of altered renal function with exenatide, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring hemodialysis or kidney transplantation.

Use caution when initiating BYDUREON BCISE in elderly patients because they are more likely to have decreased renal function.

BYDUREON BCISE is not recommended for use in patients with an eGFR below 45 mL/min/1.73²  or end-stage renal disease and should be used with caution in patients with renal transplantation.

Exenatide has not been studied in patients with severe gastrointestinal disease, including gastroparesis. The use of BYDUREON BCISE is not recommended in patients with severe gastrointestinal disease. 

Patients may develop antibodies to exenatide following treatment with BYDUREON BCISE.

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.

Increases in heart rate from baseline ranging from 1.5 to 4.5 beats per minute have been observed in comparator-controlled clinical trials.

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

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

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

The risk of hypoglycemia is increased when BYDUREON BCISE is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Patients may require a lower dose of the secretagogue or insulin to reduce the risk of hypoglycemia in this setting.

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

There is no information regarding the presence of exenatide in human milk, the effects of exenatide on the breastfed infant, or the effects of exenatide on milk production. Exenatide, the active ingredient in BYDUREON BCISE, 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.