Diabetes:
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.
Boxed Warning:
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.
Adverse Reactions:
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:
NO
How Supplied:
Single-dose autoinjectors—4
