exenatide injectable suspension (Rx)

Brand and Other Names:Bydureon, Bydureon BCise
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Dosing & Uses


Dosage Forms & Strengths

injectable suspension, autoinjector

  • 2mg/0.85 mL (Bydureon BCise)

injectable suspension, pen-injector (discontinued)

  • 2mg (Bydureon)

injectable suspension, vial

  • 2mg/vial (Bydureon)

Type 2 Diabetes Mellitus

Indicated as adjunct to diet and exercise to improve glycemic control with type 2 diabetes mellitus (DM)

2 mg SC qWeek

Initiating therapy

  • Prior treatment with immediate- or extended-release exenatide product is not required when initiating Bydureon or Bydureon BCise therapy
  • If starting Bydureon or Bydureon BCise in a patient already taking Byetta, discontinue Byetta
  • Patients may experience transient (~2-4 weeks) elevations in blood glucose concentrations

Dosage Modifications

Hepatic impairment: Not studied

Renal impairment

  • Pharmacokinetic studies indicated an increase in exposure in moderate and mild renally impaired patients as compared to patients with normal renal function
  • Mild (eGFR >45 mL/min/1.73 m²): Monitor for adverse reactions that may lead to hypovolemia
  • Severe (eGFR <45 mL/min/1.73 m²) or end-stage renal disease (ESRD): Not recommended
  • Renal transplantation: Closely monitor for adverse reactions that may lead to hypovolemia

Dosing Considerations

Limitations of use

  • Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
  • Should not be used to treat type 1 diabetes or diabetic ketoacidosis
  • Use with insulin has not been studied and is not recommended
  • Bydureon BCise and Bydureon is an extended-release formulation of exenatide; do not coadminister with other exenatide containing products
  • Patients with a history of pancreatitis has not been studied; consider other antidiabetic therapies in patients with a history of pancreatitis
  • Concurrent use with prandial insulin has not been studied

Safety and efficacy not established

Bydureon and Bydureon BCise

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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            Adverse Effects


            Injection site nodule, Bydureon BCise (10.5%)


            • Nausea (11-24%)
            • Diarrhea (11-20%)
            • Hypoglycemia (with sulfonylurea) (12.5-20%)
            • Vomiting (11.3%)



            • 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%)

            Bydureon BCise

            • Nausea (8.2%)
            • Headache (4.4%)
            • Diarrhea (4%)
            • Vomiting (3.4%)
            • Injection site pruritus (3.2%)
            • Dizziness (2.5%)
            • Injection site erythema (2.3%)
            • Constipation (2.1%)

            Postmarketing Reports

            Allergy/hypersensitivity: Injection-site reactions, generalized pruritus and/or urticaria, macular or papular rash, angioedema; anaphylactic reaction

            Drug interactions: Increased INR sometimes associated with bleeding, with concomitant warfarin

            Gastrointestinal: Nausea, vomiting, and/or diarrhea resulting in dehydration; abdominal distension, abdominal pain, eructation, constipation, flatulence, acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death

            Neurologic: Dysgeusia; somnolence

            Renal and urinary disorders: Altered renal function (eg, increased serum creatinine, renal impairment, worsened chronic renal failure or acute renal failure [sometimes requiring hemodialysis], kidney transplant and kidney transplant dysfunction)

            Skin and subcutaneous tissue disorders: Alopecia



            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
            • Counsel patients regarding the potential risk of MTC and symptoms (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness) of thyroid tumors


            Hypersensitivity to exenatide or to any of the product components

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


            Avoid concurrent use of extended release (Bydureon) and immediate release xenatide (Byetta) formulations

            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)

            Pancreatitis reported, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis; discontinue promptly if pancreatitis is suspected; do not resume therapy unless alternative etiology of pancreatitis is confirmed; consider alternative antidiabetic therapy in patients with history of pancreatitis

            Reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema); inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist for allergic reactions; it is unknown whether such patients will be predisposed to anaphylaxis (see Contraindications)

            Antibodies to exenatide following treatment may develop; anti-exenatide antibodies were measured in controlled studies; patients with higher titer antibodies may have an attenuated HbA1c response; if glycemic control worsens, consider alternative antidiabetic therapy

            Not recommended with severe gastrointestinal disease (eg, gastroparesis)

            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

            There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction

            Pen shaped injection devices should not be used by more than one person, even if needle is changed as it increases risk of infection

            Not for use in patients with type 1 diabetes mellitus or diabetic ketoacidosis

            Acute events of gallbladder disease reported in GLP-1 receptor agonist trials; if cholelithiasis suspected, gallbladder studies and appropriate clinical follow-up indicated

            Acute kidney injury

            • Renal impairment reported, including some instances requiring hemodialysis and kidney transplantation; not recommended if severe renal impairment or ESRD exist
            • Caution in patients with renal transplantation or moderate renal impairment
            • Not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min) or end-stage renal disease; should be used with caution in patients with renal transplantation
            • Therapy may induce nausea and vomiting with transient hypovolemia and may worsen renal function; not recommended for use in patients with an eGFR below 45mL/min/1.73 m²

            Drug interactions overview

            • Use caution when administering oral medications with Bydureon and Bydureon BCise where a slower rate of oral absorption may be clinically meaningful
            • Postmarketing reports for exenatide of increased INR with concomitant use of warfarin, sometimes associated with bleeding; monitor INR
            • Risk of hypoglycemia is increased when exenatide is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin; lower dose of the secretagogue or insulin to reduce risk of hypoglycemia; inform patients using these concomitant medications of risk of hypoglycemia and educate them on signs and symptoms of hypoglycemia

            Pregnancy & Lactation


            Limited data with exenatide in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage

            Based on animal reproduction studies, there may be risks to the fetus from exposure to exenatide injection during pregnancy

            Use exenatide injection during pregnancy only if the potential benefit justifies the potential risk to the fetus

            Animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide extended-release during pregnancy or from exposure to exenatide during pregnancy and lactation, in association with maternal effects


            There is no information on the presence of exenatide, in human milk, the effects of exenatide on the breastfed infant, or the effects of exenatide on milk production

            Exenatide was present in the milk of lactating mice; exenatide concentration in milk was up to 2.5% of the concentration in maternal plasma after administering SC injection twice a day

            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.



            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



            • Peak plasma time: Gradual increase observed over 6-7 weeks after initiating
            • Peak plasma concentration: 300 pg/mL (after 6-7 weeks)

            Bydureon BCise

            • Peak plasma concentration, steady-state: 208 pg/mL


            Vd: 28.3 L


            Renal clearance: 9.1 L/hr

            Excretion: Predominantly urine



            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
            • Final concentration of suspension is 2 mg/0.65 mL
            • Suspension should be white to off-white and cloudy

            Bydureon BCise

            • Remove autoinjector from the refrigerator 15 minutes prior to resuspending the suspension
            • Shake vigorously for at least 15 seconds
            • Drug should appear as an opaque, white to off-white suspension (autoinjector contains microspheres which appear as white to off-white particles)
            • Visually inspect for particulate matter and discoloration prior to administration
            • Do not use if foreign particulate matter is present or if discoloration is observed

            SC Administration

            SC use only

            Use immediately after autoinjector is prepared or following reconstitution (vial)

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

            Rotate injection sites each week when injecting in the same region

            Do not administer IV or IM

            Administer with or without meals

            Administration with basal insulin

            • Always administer exenatide and basal insulin as separate injections; do not mix these medications together into a single injection
            • It is acceptable to inject exenatide and basal insulin in the same body region, but the injections should not be adjacent to each other

            Missed dose

            • Missed dose and next dose is due at least 3 days later: Administer dose as soon as possible; resume usual dosing schedule of qWeek thereafter
            • Missed dose and next dose is due 1 or 2 days later: Do not administer missed dose; resume next regularly scheduled dose


            Keep out of reach of children

            Unopened vials or autoinjectors

            • Refrigerate at 36-46°F (2-8°C); do not freeze; do not use if suspension has been frozen
            • Protect from light If needed, can be kept at room temperature (not to exceed 77°F [25°C]) for no more than a total of 4 weeks

            Reconstituted vials

            • Use immediately, do not store




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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.
            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
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