BYDUREON BCISE Rx
Generic Name and Formulations:
Exenatide ext-rel 2mg; susp for SC inj; contains sucrose.
Indications for BYDUREON BCISE:
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 immed- or another ext-rel exenatide product: discontinue, then start Bydureon BCise.
History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.
Risk of thyroid C-cell tumors.
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.
Glucagon-like peptide-1 (GLP-1) receptor agonist.
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.
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