exenatide injectable suspension (Rx)Brand and Other Names:Bydureon

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable suspension

  • 2mg/vial
  • 2mg/syringe pen
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Diabetes Mellitus Type 2

Indicated as adjunct to diet and exercise to improve glycemic control with DM type 2; not recommended as first-line therapy if inadequately controlled on diet and exercise; use with insulin has not been studied and is not recommended

2 mg SC once weekly

Changing from Byetta to Bydureon

  • Prior treatment with Byetta (short-acting exenatide) is not required when initiating Bydureon therapy
  • If starting Bydureon in a patient already taking Byetta, discontinue Byetta
  • Patients may experience transient (~2 weeks) elevations in blood glucose concentrations

Dosage Modifications

Renal impairment

  • Mild (CrCl 50-80 mL/min): No dosage adjustment required
  • Moderate (CrCl 30-50 mL/min): Caution when initiating or escalating dose
  • Severe (CrCl <30 mL/min) or ESRD: Not recommended
  • Renal transplantation: Use with caution

Hepatic impairment

  • Has not been studied; cleared primarily by the kidney; hepatic impairment is not expected to affect blood concentrations

Safety and efficacy not established

In the 5 comparator-controlled trials exenatide injectable suspension was studied in 132 patients (16.6%) who were at least 65 years old and 20 patients who were at least 75 years old

No differences in safety or efficacy were observed between these patients and younger patients

Because elderly patients are more likely to have decreased renal function, use caution

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Interactions

Interaction Checker

exenatide injectable suspension and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nausea (11-24%)

            Diarrhea (11-20%)

            Hypoglycemia (with sulfonylurea) (12.5-20%)

            Vomiting (11.3%)

            1-10%

            Headache (9.4%)

            Constipation (8.5%)

            Headache (8.1%)

            Dyspepsia (7.3%)

            Constipation (6.3%)

            Fatigue (5.6%)

            Dyspepsia (5%)

            Decreased appetite (5%)

            Injection site pruritus (5%)

            Hypoglycemia (without sulfonylurea) (1.3-3.7%)

            Postmarketing Reports

            Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis

            Allergy and hypersensitivity: Injection-site reactions

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            Warnings

            Black Box Warnings

            Risk of thyroid C-cell tumors

            • Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls; unknown whether this risk for medullary thyroid carcinoma (MTC) exists in humans, as human relevance could not be determined by clinical or nonclinical studies
            • Contraindicated in patients with a personal or family history of MTC and in patients 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 injectable suspension
            • Patients should be counseled regarding the risk and symptoms of thyroid tumors

            Contraindications

            Hypersensitivity

            Personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2 (see Black Box Warnings)

            Cautions

            Do not administer Byetta and Bydureon concomitantly

            Serious injection-site reactions (eg, abscess, cellulitis, and necrosis) reported, with or without SC nodules; some required surgical intervention

            Thyroid C-cell tumors in animals observed; human relevance unknown (see Black Box Warnings); routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with exenatide injectable suspension; significantly elevated serum calcitonin may indicate MTC; patients with MTC usually have values >50 ng/L; if serum calcitonin is measured and found to be elevated, evaluate patient further; patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated

            Pancreatitis reported, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis; discontinue promptly if pancreatitis is suspected

            Increased risk of hypoglycemia when used in combination with a sulfonylurea or insulin; consider reducing sulfonylurea or insulin dose

            Renal impairment reported, including some instances requiring hemodialysis and kidney transplantation; not recommended if severe renal impairment or end-stage renal disease exist

            Caution in patients with renal transplantation or moderate renal impairment

            Not recommended with severe gastrointestinal disease (eg, gastroparesis)

            Reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema)

            Because exenatide slows gastric emptying, and therefore may reduce absorption rate of some orally administered drugs

            Evaluate patient further If serum calcitonin is measured and found to be elevated

            Evaluate further patients with thyroid nodules noted on physical examination or neck imaging

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            Pregnancy & Lactation

            Pregnancy Category: C; Based on animal data, may cause fetal harm; use during pregnancy only if the potential benefit justifies the potential risk to the fetus

            Lactation: Unknown whether distributed in human breast milk; caution advised

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

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

            Incretins, such as GLP-1, enhance glucose-dependent insulin secretion by pancreatic beta-cells, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying

            Absorption

            Peak Plasma Time: Gradual increase observed over 6-7 weeks after initiating

            Peak Plasma Concentration: 300 pg/mL (after 6-7 weeks)

            Distribution

            Vd: 28/3 L

            Elimination

            Renal clearance: 9.1 L/hr

            Excretion: predominantly urine

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            Administration

            SC Preparation

            Examine diluent provided to be sure that it is clear and free of particulate matter

            Suspend powder in vial with diluent provided and transfer to syringe

            The suspension should be white to off-white and cloudy

            SC Administration

            Use immediately following reconstitution

            Administer as SC injection in abdomen, thigh or upper arm region

            Rotate injection site each week

            Storage

            Unopened vials should be stored in the refrigerator at 36-46°F (2-8°C) and protected from light

            Do not freeze; do not use Bydureon if it has been frozen

            If needed, each single-dose tray can be kept at room temperature (not to exceed 77°F [25°C]) for no more than a total of 4 weeks

            Reconstituted vial: Use immediately, do not store

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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