Diabetes:
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.
Adult:
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.
Children:
Not recommended.
Contraindications:
History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.
Boxed Warning:
Risk of thyroid C-cell tumors.
Warnings/Precautions:
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.
See Also:
Pharmacologic Class:
Glucagon-like peptide-1 (GLP-1) receptor agonist.
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, renal impairment, pancreatitis (may be fatal), hypersensitivity reactions (discontinue if occur), possible antibody formation (glycemic response may be attenuated).
Generic Availability:
NO
How Supplied:
Single-dose pens—4 (each contains 1 Bydureon Pen + 1 needle); BCise single-dose autoinjectors—4
