Indications for: BYDUREON BCISE
Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes.
Limitations of Use:
Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Not for treating type 1 diabetes. Not studied in patients with a history of pancreatitis.
Adults and Children:
<10yrs: not established. Give by SC inj in abdomen, thigh, or upper arm; rotate inj sites. Inject immediately after mixing. ≥10yrs: 2mg once every 7 days (weekly). Switching from immed- or another ext-rel exenatide product: discontinue, then start Bydureon BCise.
BYDUREON BCISE Contraindications:
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.
BYDUREON BCISE Warnings/Precautions:
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. Acute gallbladder disease (eg, cholelithiasis, cholecystitis). Perform gallbladder studies and clinical follow-up if cholelithiasis is suspected. Severe GI disorders, eGFR <45mL/min/1.73m2, ESRD: not recommended. Renal transplantation (monitor). Hepatic or severe renal impairment: not studied. Elderly. Pregnancy. Nursing mothers.
BYDUREON BCISE Classification:
Glucagon-like peptide-1 (GLP-1) receptor agonist.
BYDUREON BCISE Interactions:
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).
Generic Drug Availability: