PDR MEMBER LOGIN:
  • PDR Search

    Required field
  • Advertisement
  • 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 with a personal or family history of MTC and with multiple endocrine neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with exenatide. Counsel patients on the risk and symptoms of thyroid tumors.

    THERAPEUTIC CLASS

    Glucagon-like peptide-1 receptor agonist

    DEA CLASS

    RX

    INDICATIONS

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

    ADULT DOSAGE

    Adults: Usual: 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 with Byetta is not required when initiating therapy.

    ADMINISTRATION

    SQ route. Administer with or without meals. Inject in the abdomen, thigh, or upper arm region; use a different inj site each week when injecting in the same region. 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 or family history of MTC.

    WARNINGS/PRECAUTIONS

    Not for IV or IM administration. Not recommended as 1st-line therapy with 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 with insulin. Should not be used with other drugs containing the same active ingredient (eg, Byetta). Patients changing from Byetta may experience transient (approximately 2 weeks) elevations in blood glucose concentrations. Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, reported; observe for signs/symptoms of pancreatitis after initiation of therapy, d/c promptly if suspected, and do not restart therapy if confirmed. Consider other antidiabetic therapies in patients with history of pancreatitis. Refer patients with thyroid nodules and/or elevated calcitonin levels to an endocrinologist for further evaluation. Altered renal function, including increased SrCr, renal impairment, worsened chronic renal failure, and acute renal failure reported; avoid with severe renal impairment (CrCl <30mL/min) or end-stage renal disease. Caution with renal transplantation and moderate renal impairment (CrCl 30-50mL/min). Avoid with 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), with/without subcutaneous nodules reported; isolated cases required surgical intervention. Caution in elderly.

    ADVERSE REACTIONS

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

    DRUG INTERACTIONS

    Increased risk of hypoglycemia with 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 with oral medications. May increase INR with warfarin, sometimes associated with bleeding; monitor INR more frequently after initiation of therapy.

    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 or 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 with/without 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 single-dose tray with 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 with 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. Do not freeze; do not use if product has been frozen. Protect from light.