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exenatide injectable solution (Rx)Brand and Other Names:Byetta

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution, prefilled pen

  • 250mcg/mL (1.2mL vial)
  • 250mcg/mL (2.4mL vial)
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Diabetes Mellitus, Type 2

Adjunct to diet and exercise to improve glycemic control with DM type 2; monotherapy or as an adjunct therapy with thiazolidinediones, metformin, or a sulfonylurea; or add-on therapy to insulin glargine (a long-acting insulin), with or without metformin and/or a thiazolidinedione, in patients who are not achieving adequate glycemic control on insulin glargine alone

Immediate-release: 5 mcg SC q12hr within 60 minutes prior to meal intially; after 1 month, may increased to 10 mcg q12hr

Switching from immediate-release to extended-release

  • Initiate weekly extended-release SC injections 1 day after discontinuing immediate-release exenatide
  • May experience increased blood glucose levels for approximately 2 weeks after initiating extended-release therapy
  • May initiate extended-release exenatide without pretreating with the immediate-release dosage form

Administration

Within 60 minutes before morning and evening meals, approximately 6 hr or more apart

Administer SC only; do not administer IM or IV

Injection sites are thigh, abdomen, or upper arm

Dosing Modifications

Renal impairment

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

Safety and efficacy not established

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Interactions

Interaction Checker

exenatide injectable solution 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%

            Injection-site nodule (6-77%)

            Injection-site reactions (2-18%)

            Nausea (8-11%)

            Vomiting (4-11%)

            Diarrhea (2-11%)

            1-10%

            Constipation (6-10%)

            Headache (5-9%)

            Dyspepsia (3-7%)

            Hyperhidrosis (3%)

            Jitteriness (<3%)

            Dizziness (<2%)

            Asthenia

            Postmarketing Reports

            Alopecia

            Anaphylactic reaction

            Angioedema

            Pancreatitis

            Rash

            Renal impairment

            Upper respiratory infection

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            Warnings

            Black Box Warnings

            Risk of thyroid C-cell tumors

            • 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

            ESRD, severe renal impairment (CrCl <30 mL/min)

            Family or current history of medullary thyroid carcinoma

            Cautions

            Never share a pen between patients even if the needle is changed

            Not a substitute for insulin

            Not a first-line therapy for patients inadequately controlled on diet and exercise alone

            Evaluate insulin dose when added on to long-acting insulin (ie, insulin glargine); in patients with increased risk of hypoglycemia, consider decreasing insulin dose

            Not recommended for patients experiencing severe gastrointestinal disease, including gastroparesis

            Not recommended for type 1 diabetes

            Do not take with short- and/or rapid-acting insulins

            Animal studies show association of extended-release dosage form with the formation of thyroid tumors (effects in humans unknown)

            Always administer before a meal and never after a meal

            Weight loss resulting from reduced intake reported

            Risk of acute pancreatitis reported, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis

            Increased risk of hypoglycemia in patients taking insulin secretagogues; may require dose reduction of sulfonylureas

            Risk of renal failure

            Antibody formation to exenatide is likely; up to 4% of patients may have worsening glycemic control and require alternative antidiabetic therapy

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Excretion in milk unknown; use with caution

            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

            A glucagonlike peptide-1 (GLP-1) that mimics incretin and promotes insulin secretion, suppresses glucagon, and slows gastric emptying

            Absorption

            Peak plasma time: 2.1 hr

            Peak plasma concentration: 211 pg/mL

            AUC: 1036 pg·hr/mL

            Distribution

            Vd: 28.3 L

            Metabolism

            Proteolytic degradation following glomerular filtration

            Elimination

            Half-life: 2.4 hr (immediate release); 2 weeks (extended release)

            Renal clearance: 9.1 L/hr

            Excretion: Urine (primarily)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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