Thyroid carcinoma (MTC) in humans, as the human relevance of exenatideД®xtended-release-induced rodent thyroid C-cell tumors has not been determined Use during pregnancy only if the potential benefit justifies the potential risk

Monitor INR frequently until stable upon initiation of BYDUREON BCise Sometimes associated with bleeding has been reported with concomitant use of exenatide with Warfarin Increased international normalized ratio (INR) May reduce the rate of absorption of orally administered drugs Oral Medications BYDUREON BCise slows gastric emptying and Adverse reactions in patients 10 to 17 years of age treated with BYDUREON (exenatide extended-release) were similar to that in adults Most common (в‰Ґ5%) in clinical trials: injection-site nodule (10.5%), nausea (8.2%).

IfД¬holelithiasis or cholecystitis are suspected, gallbladder studies are indicated Injection-Site Reactions Serious reactions (eg, abscess,Д¬ellulitis, and necrosis), with or without subcutaneous nodules, have been reportedДЄcute Gallbladder Disease has been reported in GLP-1 receptor agonist trials, including exenatide. Discontinue promptly if suspected and avoid re-exposure to exenatide Serious bleeding, which may be fatal, has been If this occurs, patients should discontinueД«YDUREON BCise and promptly seek medical adviceДrug-induced, immune-mediated thrombocytopenia and associatedД«leeding has been reported with exenatide. Reactions (eg, anaphylaxis and angioedema). Hypersensitivity Reports of serious hypersensitivity Worsening of or failure to achieve adequate glycemic control occurs, consider alternative Trials, attenuated glycemic response was associated with BYDUREON BCise-treated patients. Patients with higher titer antibodies may have an attenuated HbA1c response. Immunogenicity Patients may develop antibodies to exenatide. Gastrointestinal disease (eg, gastroparesis) Gastrointestinal Disease Because exenatide is commonlyДЄssociated with gastrointestinal adverse reactions, not recommended in patients with severe Hemodialysis and kidney transplantation have been reported. Impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring Transient hypovolemia and may worsen renal function. Consider lowering the dose of these agents when coadministered with BYDUREON BCiseДЄcute Kidney Injury May induce nausea and vomiting with Hypoglycemia Risk of hypoglycemia, including severe hypoglycemia, is increased when exenatide is coadministered with insulin or insulin secretagogues. Consider other antidiabetic therapies in patients with a history of pancreatitis If suspected, discontinue promptly and do not restart ifД¬onfirmed.

After initiation, observe patients carefullyДЇor symptoms of pancreatitis. Or necrotizing pancreatitis has been reported. History of drug-induced, immune-mediated thrombocytopenia from exenatide productsДЄcute Pancreatitis including fatal and non-fatal hemorrhagic Prior serious hypersensitivity reactions to exenatide or product components Personal or family history of MTC, patients with MEN 2 Uncertain value for detection of MTC in patients treated with BYDUREON BCise Routine monitoring of serum calcitonin or using thyroid ultrasound is of Them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent Patients regarding the potential risk of MTC with the use of BYDUREON BCise and inform MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determinedД«YDUREON BCise is contraindicated in patients with a personal or family history of It is unknown whether BYDUREON BCise causes thyroid C-cell tumors, including medullary In thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. Exenatide extended-release causes an increased incidence

Tab suspender extension