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Bydureon Bcise Generic Name & Formulations
Legal Class
Rx
General Description
Exenatide ext-rel 2mg; susp for SC inj; contains sucrose.
Pharmacological Class
Glucagon-like peptide-1 (GLP-1) receptor agonist.
How Supplied
Single-dose autoinjectors—4
Manufacturer
Generic Availability
NO
Bydureon Bcise Indications
Indications
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.
Bydureon Bcise Dosage and Administration
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
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.
Bydureon Bcise Boxed Warnings
Boxed Warning
Risk of thyroid C-cell tumors.
Bydureon Bcise Warnings/Precautions
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 Pharmacokinetics
See Literature
Bydureon Bcise Interactions
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.
Bydureon Bcise Adverse Reactions
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).
Bydureon Bcise Clinical Trials
See Literature
Bydureon Bcise Note
Not Applicable
Bydureon Bcise Patient Counseling
See Literature
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