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). Switching from immed- or another ext-rel exenatide product: discontinue, then start Bydureon or Bydureon BCise.
History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2. History of drug-induced immune-mediated thrombocytopenia from exenatide products.
Risk of thyroid C-cell tumors.
Risk of thyroid C-cell tumors; inform patients of potential risk and symptoms. Do not share pens between patients. History of pancreatitis; consider other antidiabetics. Monitor for pancreatitis, drug-induced thrombocytopenia; discontinue if suspected; do not restart if confirmed. History of anaphylaxis or angioedema with another GLP-1 agonist; monitor closely. Risk of acute gallbladder disease; evaluate if cholelithiasis is suspected. Severe GI disorders, eGFR <45mL/min/1.73m2, ESRD: not recommended. Renal transplantation (monitor). 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, hypersensitivity reactions (discontinue if occur), possible antibody formation (glycemic response may be attenuated).
Single-dose pens—4 (each contains 1 Bydureon Pen + 1 needle); BCise single-dose autoinjectors—4