These may be symptoms of thyroid cancer. You may give another person an infection or get an infection from them Inflammation of the pancreas pancreatitis Stop using BYDUREON and call your healthcare provider right away if you have severe pain in your stomach area abdomen that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back Low blood sugar hypoglycemia Your risk for getting low blood sugar may be higher if you use BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Tell your healthcare provider if you take other diabetes medicines. Talk to your healthcare provider about managing low blood sugar. Signs and symptoms of low blood sugar may include dizziness or lightheadedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery Kidney problems Tell your healthcare provider if you have or had kidney problems.
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After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues.
Increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported. Not recommended in patients with eGFR 2 Gastrointestinal Disease Because exenatide is commonly associated with gastrointestinal adverse reactions, not recommended in patients with severe gastrointestinal disease eg, gastroparesis Immunogenicity Patients may develop antibodies to exenatide.
Patients with higher titer antibodies may have an attenuated HbA1c response. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy Hypersensitivity Reports of serious hypersensitivity reactions eg, anaphylaxis and angioedema. Serious bleeding, which may be fatal, has been reported. Discontinue promptly if suspected and avoid re-exposure to exenatide Injection-Site Reactions Serious reactions eg, abscess, cellulitis, and necrosis , with or without subcutaneous nodules, have been reported Acute Gallbladder Disease has been reported in GLP-1 receptor agonist trials, including exenatide.
Should not be used to treat type 1 diabetes or diabetic ketoacidosis Not studied with prandial insulin Do not coadminister with other exenatide-containing products Not studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis You may report side effects related to AstraZeneca products by clicking here.
Consider other antidiabetic therapies in patients with a history of pancreatitis Never Share Injection Device or Needle Between Patients Sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues.
Altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported.
BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with moderate renal impairment or renal transplantation Gastrointestinal Disease Because exenatide is commonly associated with gastrointestinal adverse reactions, not recommended in patients with severe gastrointestinal disease eg, gastroparesis Immunogenicity Patients may develop antibodies to exenatide.
Serious bleeding associated with profound thrombocytopenia may be potentially fatal. Discontinue promptly if suspected and avoid re-exposure to exenatide Injection-Site Reactions Serious reactions eg, abscess, cellulitis, and necrosis , with or without subcutaneous nodules, have been reported with extended-release exenatide Acute Gallbladder Disease has been reported in GLP-1 receptor agonist trials, including exenatide.
One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial.
Diabetes Care. Effects of exenatide on measures of beta-cell function after 3 years in metformin-treated patients with type 2 diabetes. DeFronzo RA. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. GLP-1 receptor activation modulates appetite- and reward-related brain areas in humans.
Glucagon-like peptide-1 reduces hepatic glucose production indirectly through insulin and glucagon in humans.
Acta Physiol Scand. Pharmacology, physiology, and mechanisms of incretin hormone action. Cell Metab. Pathophysiologic approach to therapy in patients with newly diagnosed type 2 diabetes. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm — executive summary. Endocr Pract. Glucose metabolism and regulation: beyond insulin and glucagon.
Diabetes Spectrum. Prasad-Reddy L, Isaacs D. A clinical review of GLP-1 receptor agonists: efficacy and safety in diabetes and beyond. Drugs Context. Accessed April 19, Encapsulation of exenatide in poly- D,L-lactide-co-glycolide microspheres produced an investigational long-acting once-weekly formulation for type 2 diabetes.
Diabetes Technol Ther. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Diabetes Obes Metab. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes DURATION-2 : a randomised trial. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes DURATION-4 : a week double-blind study.
DURATION exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab. Abbreviation: T2D, type 2 diabetes. References: Data on file, REF AstraZeneca Pharmaceuticals LP. Exenatide once weekly improved hour glucose control and reduced glycaemic variability in metformin-treated participants with type 2 diabetes: a randomized, placebo-controlled trial [published online ahead of print August 16, ].
Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy DURATION-8 : a 28 week, multicentre, double-blind, phase 3, randomised controlled trial.
Lancet Diabetes Endocrinol. Data on file, REF Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study.
Poster P. Abbreviations: PK, pharmacokinetics. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes. N Engl J Med.
IMPORTANT SAFETY INFORMATION
Hold the bottom of the pen with 1 hand. While continuing to hold the pen straight up, tap it against your other palm. After every 3 taps, rotate the pen a little before tapping it again. It can take 80 taps or more before the medicine is ready to be used.
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