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BYDUREON
Diabetes
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Drug Name:

BYDUREON Rx

Generic Name and Formulations:
Exenatide ext-rel 2mg; pwd for SC inj after reconstitution.

Company:
AstraZeneca Pharmaceuticals

Therapeutic Use:

Indications for BYDUREON:

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 insulin or with history of pancreatitis.

Adult:

Give by SC inj in abdomen, thigh, or upper arm. Inject immediately after mixing. 2mg once every 7 days (weekly). Changing from Byetta: discontinue, then start Bydureon.

Children:

Not recommended.

Contraindications:

History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.

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. Severe GI disorders, renal impairment (CrCl <30mL/min), end-stage renal disease: not recommended. Renal transplantation. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Increased risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas) or insulin; may need lower dose of these. May delay absorption of oral drugs. Monitor warfarin.

Pharmacological Class:

Glucagon-like peptide-1 (GLP-1) receptor agonist.

Adverse Reactions:

Nausea, diarrhea, headache, vomiting, constipation, dyspepsia, inj site reactions; possible antibody formation (glycemic response may be attenuated), pancreatitis (may be fatal), hypersensitivity reactions.

How Supplied:

Single-dose trays—4 (each contains 1 vial, 1 prefilled syringe with diluent, vial connector and custom needles); Single-dose pens—4 (each contains 1 Bydureon Pen and 1 custom needle)

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