Tanzeum (Albiglutide)

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  • Product Details

    Description

    Tanzeum (albiglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist formerly indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Albiglutide is a recombinant fusion protein consisting of two copies of modified human GLP-1 linked to human albumin, prolonging its half-life and allowing for once-weekly subcutaneous dosing. It exerts its glucose-lowering effect by enhancing glucose-dependent insulin secretion, suppressing inappropriate glucagon secretion, and slowing gastric emptying.

    Note: As of July 2018, Tanzeum was withdrawn from the U.S. market by the manufacturer (GlaxoSmithKline) due to commercial reasons, not safety or efficacy concerns. It is no longer available for prescribing in most regions.

    Fact Table

    Formula

    C2538H3892N746O781S40

    License

    US FDA (withdrawn)

    Bioavailability

    Approximately 89%

    Legal status

    Rx-only (withdrawn)

    Chemical Name

    Albiglutide

    Elimination half-life

    ~5 days

    Dosage (Strength)

    30 mg or 50 mg once weekly (subcutaneous)

    Pregnancy

    Consult a doctor (Category C)

    Brands

    Tanzeum (US), Eperzan (EU)

    Protein binding

    Not applicable (large protein)

    PubChem CID

    56843311

    MedlinePlus

    a614034

    ChEBI

    134722

    ATC code

    A10BJ04

    DrugBank

    DB09045

    KEGG

    D10333

    Routes of administration

    Subcutaneous injection

    Directions

    When it was available, Tanzeum was administered via subcutaneous injection once weekly, at any time of day, with or without meals. The recommended starting dose was 30 mg once weekly, which could be increased to 50 mg if additional glycemic control was needed. The injection was delivered using a single-dose reconstitutable pen, requiring mixing just prior to administration. It was injected into the abdomen, thigh, or upper arm, with rotation of sites to reduce local reactions.

    Ingredients

    Each Tanzeum pen contained:

    • Albiglutide (30 mg or 50 mg per dose)
    • Mannitol
    • Sodium phosphate monobasic monohydrate
    • Sodium phosphate dibasic heptahydrate
    • Polysorbate 80
    • Water for injection (for reconstitution)

    Contraindications

    Tanzeum was contraindicated in patients with:

    • Personal or family history of medullary thyroid carcinoma (MTC)
    • Patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
    • Known hypersensitivity to albiglutide or any excipients in the formulation

    Cautions

    As with other GLP-1 receptor agonists, Tanzeum carried a boxed warning regarding the potential risk of thyroid C-cell tumors, based on rodent studies (not confirmed in humans). It was not recommended as first-line therapy for type 2 diabetes. Caution was advised in patients with pancreatitis, gastrointestinal disease, or renal impairment. Monitoring was advised for signs of thyroid nodules, hypersensitivity reactions, and hypoglycemia, particularly when used with insulin or sulfonylureas.

    Side Effects

    Common side effects of Tanzeum included:

    • Nausea
    • Diarrhea
    • Injection site reactions
    • Upper respiratory tract infection
    • Headache
    • Dizziness

    Serious adverse effects included:

    • Pancreatitis
    • Hypersensitivity reactions (e.g., angioedema)
    • Renal impairment
    • Thyroid C-cell tumors (based on animal data)

    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 : 14598

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