Generic Name and Formulations:
Exenatide ext-rel 2mg; per vial or pen; for injectable suspension.
Indications for BYDUREON:
Adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes.
Limitations Of use:
Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Not a substitute for insulin. Not for treating type 1 diabetes or diabetic ketoacidosis. Not studied in combination with prandial insulin or with history of pancreatitis.
Give by SC inj in abdomen, thigh, or upper arm; rotate inj sites. Inject immediately after mixing. 2mg once every 7 days (weekly). Changing from Byetta: discontinue, then start Bydureon.
History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.
Risk of thyroid C-cell tumors possible; monitor. History of pancreatitis; consider other antidiabetics. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. History of anaphylaxis or angioedema with another GLP-1 agonist; monitor closely. Severe GI disorders, renal impairment (CrCl <30mL/min), end-stage renal disease: not recommended. Renal transplantation. Moderate renal impairment. Elderly. Pregnancy. Nursing mothers.
Do not mix with insulins; avoid adjacent inj sites. Increased risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas) or insulin; may need lower dose of these. May delay absorption of oral drugs (eg, acetaminophen). Monitor INR more frequently with warfarin.
Glucagon-like peptide-1 (GLP-1) receptor agonist.
Nausea, diarrhea, headache, vomiting, constipation, dyspepsia, inj site reactions (eg, pruritus, nodule); acute kidney injury, renal impairment, pancreatitis (may be fatal), hypersensitivity reactions (discontinue if occur), possible antibody formation (glycemic response may be attenuated).
Single-dose trays—4 (each contains 1 vial, 1 prefilled syringe with diluent + supplies); Single-dose pens—4 (each contains 1 Bydureon Pen + 1 needle); BCise single-dose autoinjectors—4