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  • Bydureon
    (exenatide)

    BOXED WARNING

    Causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in animal studies. It is unknown whether drug causes thyroid C-cell tumors (eg, medullary thyroid carcinoma [MTC]) in humans. Contraindicated in patients w/ a personal/family history of MTC and w/ multiple endocrine neoplasia syndrome type 2 (MEN 2). Counsel patients on the potential risk for MTC w/ exenatide use and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated w/ exenatide.

    THERAPEUTIC CLASS

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

    DEA CLASS

    RX

    INDICATIONS

    Adjunct to diet and exercise to improve glycemic control in adults w/ type 2 diabetes mellitus (DM).

    ADULT DOSAGE

    Type 2 Diabetes Mellitus

    2mg/dose SQ once every 7 days, at any time of day

    Changing Weekly Dosing Schedule:
    May change the day of weekly administration if necessary as long as the last dose was given ≥3 days before

    Changing from Byetta to Bydureon:
    D/C Byetta
    Prior treatment w/ Byetta is not required when initiating therapy

    Patients changing from Byetta may experience transient (approx 2 weeks) elevations in blood glucose concentrations

    Missed Dose

    Administer as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later
    Thereafter, may resume usual dosing schedule of once every 7 days (weekly)

    If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, do not administer the missed dose and instead resume therapy w/ the next regularly scheduled dose

    DOSE MODIFICATION

    Renal Impairment
    Moderate (CrCl 30-50mL/min): Use w/ caution
    Severe (CrCl <30mL/min) or ESRD: Not recommended for use
    Patients w/ Renal Transplantation: Use w/ caution

    Elderly
    Caution when initiating treatment

    ADMINISTRATION

    SQ route

    Administer w/ or w/o meals
    Inject in the abdomen, thigh, or upper arm region; use a different inj site each week when injecting in the same region
    Do not administer IV or IM
    Intended for patient self-administration
    Administer immediately after powder is suspended in diluent
    Refer to PI for further administration instructions

    HOW SUPPLIED

    Inj, Extended-Release: 2mg [vial, pen]

    CONTRAINDICATIONS

    MEN 2, personal/family history of MTC.

    WARNINGS/PRECAUTIONS

    Not recommended as 1st-line therapy for patients who have inadequate glycemic control on diet and exercise. Not a substitute for insulin; do not use in type 1 DM or for treatment of diabetic ketoacidosis. Not studied and cannot be recommended w/ insulin. Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, reported; d/c promptly if suspected, and do not restart therapy if confirmed. Consider other antidiabetic therapies in patients w/ history of pancreatitis. Patients w/ elevated calcitonin levels and those w/ thyroid nodules noted on physical examination or neck imaging should be further evaluated. Altered renal function, including increased SrCr, renal impairment, worsened chronic renal failure, and acute renal failure reported. Avoid w/ severe GI disease. May develop antibodies; consider alternative antidiabetic therapy if there is worsening glycemic control or failure to achieve targeted glycemic control. Serious hypersensitivity reactions reported; d/c if a hypersensitivity reaction occurs. Serious inj-site reactions (eg, abscess, cellulitis, necrosis), w/ or w/o subcutaneous nodules reported; isolated cases required surgical intervention.

    ADVERSE REACTIONS

    Constipation, diarrhea, dyspepsia, headache, N/V, inj-site nodule, fatigue, decreased appetite, inj-site pruritus, viral gastroenteritis, GERD, inj-site erythema, inj-site hematoma.

    DRUG INTERACTIONS

    Increased risk of hypoglycemia w/ a sulfonylurea or other glucose-independent insulin secretagogues (eg, meglitinides); may require a lower dose of the sulfonylurea. May reduce the rate of absorption of orally administered drugs; caution w/ oral medications. May increase INR w/ warfarin, sometimes associated w/ bleeding; monitor INR more frequently after initiation of exenatide. Should not be used w/ other drugs containing the same active ingredient (eg, Byetta).

    PREGNANCY AND LACTATION

    Category C, not for use in nursing.

    MECHANISM OF ACTION

    Glucagon-like peptide-1 receptor agonist; enhances glucose-dependent insulin secretion by the pancreatic β-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying.

    PHARMACOKINETICS

    Absorption: Gradual release over 6-7 weeks. Distribution: Vd=28.3L. Elimination: Kidney.

    ASSESSMENT

    Assess for previous hypersensitivity reactions, MEN 2, personal/family history of MTC, history of pancreatitis, type of DM, diabetic ketoacidosis, renal impairment, severe GI disease, pregnancy/nursing status, and possible drug interactions. Assess glucose and HbA1c levels.

    MONITORING

    Monitor for signs/symptoms of thyroid tumor, pancreatitis, elevated serum calcitonin levels, hypoglycemia, GI events, immunogenicity, hypersensitivity reactions, inj-site reactions, and other adverse reactions. Monitor renal function, blood glucose levels, and HbA1c levels. Monitor INR more frequently after initiation of therapy in patients receiving warfarin.

    PATIENT COUNSELING

    Counsel on potential risks/benefits of therapy and alternative modes of therapy. Inform of importance of adhering to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition/management of hypo/hyperglycemia, and assessment for diabetes complications. Advise to report symptoms of thyroid tumors (eg, lump in the neck, hoarseness, dysphagia, dyspnea) to physician. Inform of potential risk for pancreatitis, worsening of renal function, and serious hypersensitivity reactions. Instruct to d/c therapy promptly and contact physician if persistent severe abdominal pain and/or symptoms of a hypersensitivity reaction occur. Inform that serious inj-site reactions w/ or w/o subcutaneous nodules may occur; advise to seek medical advice if symptomatic nodules occur, or for any signs/symptoms of abscess, cellulitis, or necrosis. Instruct to never share a prefilled syringe/pen w/ another person, even if the needle is changed. Advise that if a dose is missed, administer as soon as noticed, provided that the next regularly scheduled dose is due at least 3 days later. Instruct to then resume the usual dosing schedule thereafter. Inform that if a dose is missed and the next regularly scheduled dose is due in 1 or 2 days, to not administer the missed dose and instead resume w/ the next regularly scheduled dose. Advise to inform physician if pregnant or intending to become pregnant. Inform about the importance of proper storage, inj technique, and dosing.

    STORAGE

    2-8°C (36-46°F). May store at room temperature not exceeding 25°C (77°F) for ≤4 weeks, if needed. Do not freeze; do not use if product has been frozen. Protect from light.