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Bydureon Bcise (Exenatide)

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Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

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  • Product Details

    Description

    Bydureon is an extended-release formulation of exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist used for the treatment of type 2 diabetes mellitus in adults. It helps improve glycemic control by enhancing glucose-dependent insulin secretion, suppressing inappropriate glucagon release, slowing gastric emptying, and promoting satiety, which may support weight loss. Bydureon is designed for once-weekly subcutaneous administration, providing continuous glycemic coverage with a single dose.

    Fact Table

    Formula

    C184H282N50O60

    License

    US FDA, EMA

    Bioavailability

    ~65% (subcutaneous)

    Legal status

    Rx-only

    Chemical Name

    Exenatide (extended-release)

    Elimination half-life

    ~2 weeks (due to microsphere formulation)

    Dosage (Strength)

    2 mg once weekly (subcutaneous injection)

    Pregnancy

    Use only if clearly needed (Category C)

    Brands

    Bydureon, Bydureon BCise (prefilled autoinjector)

    Protein binding

    Not extensively bound

    PubChem CID

    16133899

    MedlinePlus

    a607050

    ChEBI

    6826

    ATC code

    A10BJ01

    DrugBank

    DB01225

    KEGG

    D04167

    Routes of administration

    Subcutaneous injection (weekly)

    Directions

    Bydureon is administered as a subcutaneous injection of 2 mg once weekly, on the same day each week, with or without meals.

    • Injection sites include the abdomen, thigh, or upper arm, rotating sites with each dose.
    • If a dose is missed, it should be taken as soon as possible within 3 days after the missed dose; then resume the regular schedule.
    • Bydureon is supplied as either a single-dose prefilled pen or a powder requiring reconstitution with a diluent in a dual-chamber syringe or vial.

    Patients should be trained in proper mixing and injection technique. Do not use in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

    Ingredients

    Each 2 mg dose contains:

    • Exenatide 2 mg
    • Poly(D,L-lactide-co-glycolide) (PLG) microspheres (for extended release)
    • Sodium chloride
    • Water for injection (diluent)

    Formulations vary slightly by device type (pen vs. vial/syringe).

    Contraindications

    Bydureon is contraindicated in patients with:

    • Personal or family history of medullary thyroid carcinoma (MTC)
    • Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
    • Known hypersensitivity to exenatide or formulation components

    Cautions

    • Bydureon carries a boxed warning for thyroid C-cell tumors (based on rodent studies; human relevance unknown).
    • Use with caution in patients with gastrointestinal disease (e.g., gastroparesis) or renal impairment.
    • Monitor renal function in patients with risk factors for acute kidney injury.
    • Pancreatitis has been reported; discontinue if suspected.
    • Not recommended for use in pediatric patients under 18 years of age.
    • Do not use in combination with other GLP-1 receptor agonists.

    Side Effects

    Common side effects include:

    • Nausea
    • Diarrhea
    • Injection site nodules
    • Constipation
    • Vomiting
    • Headache

    Serious adverse effects may include:

    • Acute pancreatitis
    • Hypoglycemia (especially when used with sulfonylureas or insulin)
    • Renal impairment
    • Hypersensitivity reactions (e.g., anaphylaxis, angioedema)
    • Thyroid C-cell tumors (observed in rodents)

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 12763

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