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Causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in animal studies. It is unknown whether drug causes thyroid C-cell tumors (eg, medullary thyroid carcinoma [MTC]) in humans. Contraindicated in patients with a personal or family history of MTC and 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. Counsel patients on the risk and symptoms of thyroid tumors.
Glucagon-like peptide-1 receptor agonist
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (DM).
Adults: Usual: 2mg/dose SQ once every 7 days, at any time of day. Changing Weekly Dosing Schedule: May change the day of weekly administration if necessary as long as the last dose was given ≥3 days before. Changing from Byetta to Bydureon: D/C Byetta. Prior treatment with Byetta is not required when initiating therapy.
Inj, Extended-Release: 2mg [vial, pen]
MEN 2, personal or family history of MTC.
Not for IV or IM administration. Not recommended as 1st-line therapy with inadequate glycemic control on diet and exercise. Not a substitute for insulin; do not use in type 1 DM or for treatment of diabetic ketoacidosis. Not studied and cannot be recommended with insulin. Should not be used with other drugs containing the same active ingredient (eg, Byetta). Patients changing from Byetta may experience transient (approximately 2 weeks) elevations in blood glucose concentrations. Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis reported; observe for signs/symptoms of pancreatitis after initiation of therapy, d/c promptly if suspected, and do not restart therapy if confirmed. Not studied in patients with history of pancreatitis; consider other antidiabetic therapies. Refer patients with thyroid nodules and/or elevated calcitonin levels to an endocrinologist for further evaluation. Altered renal function, including increased SrCr, renal impairment, worsened chronic renal failure, and acute renal failure reported; avoid with severe renal impairment (CrCl <30mL/min) or end-stage renal disease. Caution with renal transplantation and moderate renal impairment (CrCl 30-50mL/min). Avoid with severe GI disease. May develop antibodies; consider alternative antidiabetic therapy if there is worsening glycemic control or failure to achieve targeted glycemic control. Serious hypersensitivity reactions (eg, anaphylaxis, angioedema) reported; d/c if a hypersensitivity reaction occurs. Caution in elderly.
Constipation, diarrhea, dyspepsia, headache, N/V, inj-site nodule, fatigue, decreased appetite, inj-site pruritus, viral gastroenteritis, gastroesophageal reflux disease, inj-site erythema, inj-site hematoma.
Increased risk of hypoglycemia with a sulfonylurea or other glucose-independent insulin secretagogues (eg, meglitinides); may require a lower dose of the sulfonylurea. May reduce the rate of absorption of orally administered drugs; caution with oral medications. May increase INR with warfarin, sometimes associated with bleeding; monitor INR more frequently after initiation of therapy.
Category C, not for use in nursing.
Glucagon-like peptide-1 receptor agonist; enhances glucose-dependent insulin secretion by the pancreatic β-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying.
Absorption: Tmax=2 weeks (initial peak), 6-7 weeks (second peak). Distribution: Vd=28.3L. Elimination: Kidney.
Assess for previous hypersensitivity reactions, MEN 2, personal or family history of MTC, history of pancreatitis, type of DM, diabetic ketoacidosis, renal impairment, severe GI disease, pregnancy/nursing status, and possible drug interactions. Assess glucose and HbA1c levels.
Monitor for signs/symptoms of thyroid tumor, pancreatitis, elevated serum calcitonin levels, hypoglycemia, GI events, immunogenicity, hypersensitivity reactions, and other adverse reactions. Monitor renal function, blood glucose levels, and HbA1c levels. Monitor INR more frequently after initiation of therapy in patients receiving warfarin.
Counsel on potential risks/benefits of therapy and alternative modes of therapy. Inform of importance of adhering to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition/management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise to report symptoms of thyroid tumors (eg, lump in the neck, hoarseness, dysphagia, dyspnea) to physician. Inform of potential risk for pancreatitis, worsening of renal function, and serious hypersensitivity reactions. Instruct to d/c therapy promptly and contact physician if persistent severe abdominal pain and/or symptoms of a hypersensitivity reaction occur. Instruct to never share a single-dose tray with another person, even if the needle is changed. Advise that if a dose is missed, administer as soon as noticed, provided that the next regularly scheduled dose is due at least 3 days later. Instruct to then resume the usual dosing schedule thereafter. Inform that if a dose is missed and the next regularly scheduled dose is due in 1 or 2 days, to not administer the missed dose and instead resume with the next regularly scheduled dose. Advise to inform physician if pregnant or intending to become pregnant. Inform about the importance of proper storage, injection technique, and dosing.
Administration: SQ route. Administer with or without meals. Inject in the abdomen, thigh, or upper arm region; use a different inj site each week when injecting in the same region. Administer immediately after powder is suspended in diluent. Refer to PI for further administration instructions. Storage: 2-8°C (36-46°F). May store at room temperature not exceeding 25°C (77°F) for ≤4 weeks. Do not freeze; do not use if product has been frozen. Protect from light.