For adult patients with T2D uncontrolled on oral antidiabetic agent(s) in addition to diet and exercise to improve glycemic control

Easy-to-use* device to help get consistent control with once-weekly BYDUREON BCise1

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Remember to read the full Instructions for Use and Prescribing Information for BYDUREON BCise for complete instructions.

  • Before mixing, bring device to room temperature for 15 minutes and prepare injection site

  • Medicine must be evenly mixed to get full dose

    • 1) Mix - Do not unlock the device yet. With orange cap pointing up, shake the device up and down hard for at least 15 seconds. Medicine must be evenly mixed. Complete the following steps below.

    • 2) Continue to hold the device upright. Turn knob from "Lock" to "Unlock" position until you hear a "click."

    • 3) Continuing to hold the device upright, unscrew the orange cap. (Do not pull)

    • 4) To inject, push and hold device firmly against skin. To make sure you get the full dose, hold for 15 seconds.

Remember to read the full Instructions for Use and Prescribing Information for BYDUREON BCise for complete instructions.

Once-weekly exenatide in simple steps1

Click on the images below for each step.

3 simple steps to BCise dosing: Mix the medicine inside BCise, unlock BCise, and inject BCise
3 simple steps to BCise dosing: Mix the medicine inside BCise, unlock BCise, and inject BCise
3 simple steps to BCise dosing: Mix the medicine inside BCise, unlock BCise, and inject BCise
3 simple steps to BCise dosing: Mix the medicine inside BCise, unlock BCise, and inject BCise
3 simple steps to BCise dosing: Mix the medicine inside BCise, unlock BCise, and inject BCise

Preparation needed

See Instructions for Use and Prescribing Information for complete instructions.

  • The device should be stored flat in the refrigerator
  • Remove the device from the refrigerator and rest it flat for at least 15 minutes to allow it to come to room temperature
  • Do not unlock before mixing
  • Shake the autoinjector hard for at least 15 seconds until the medicine is mixed evenly
3 simple steps to BCise dosing: Mix the medicine inside BCise, unlock BCise, and inject BCise

Preparation needed

See Instructions for Use and Prescribing Information for complete instructions.

  • Do not unlock until suspension is mixed well
  • Unlock the device
3 simple steps to BCise dosing: Mix the medicine inside BCise, unlock BCise, and inject BCise

Preparation needed

See Instructions for Use and Prescribing Information for complete instructions.

  • Firmly unscrew the orange cap counterclockwise
3 simple steps to BCise dosing: Mix the medicine inside BCise, unlock BCise, and inject BCise

Preparation needed

See Instructions for Use and Prescribing Information for complete instructions.

  • Once suspension is mixed, preparation must be completed right away and the medicine injected subcutaneously to get the full dose; it cannot be saved to use later
  • Push the autoinjector against the skin and hold it there for 15 seconds to get the full dose

Preparation needed

MIX

  • The device should be stored flat in the refrigerator
  • Remove the device from the refrigerator and rest it flat for at least 15 minutes to allow it to come to room temperature
  • Do not unlock before mixing
  • Shake the autoinjector hard for at least 15 seconds until the medicine is mixed evenly

See Instructions for Use and Prescribing Information for complete instructions.

Preparation needed

UNLOCK

  • Do not unlock until suspension is mixed well
  • Unlock the device

See Instructions for Use and Prescribing Information for complete instructions.

Preparation needed

UNSCREW

  • Firmly unscrew the orange cap counterclockwise

See Instructions for Use and Prescribing Information for complete instructions.

Preparation needed

INJECT

  • Once suspension is mixed, preparation must be completed right away and the medicine injected subcutaneously to get the full dose; it cannot be saved to use later
  • Push the autoinjector against the skin and hold it there for 15 seconds to get the full dose

See Instructions for Use and Prescribing Information for complete instructions.

  • Before mixing, bring device to room temperature for 15 minutes and prepare injection site

  • Medicine must be evenly mixed to get full dose

    • 1) Mix - Do not unlock the device yet. With orange cap pointing up, shake the device up and down hard for at least 15 seconds. Medicine must be evenly mixed. Complete the following steps below.

    • 2) Continue to hold the device upright. Turn knob from "Lock" to "Unlock" position until you hear a "click."

    • 3) Continuing to hold the device upright, unscrew the orange cap. (Do not pull)

    • 4) To inject, push and hold device firmly against skin. To make sure you get the full dose, hold for 15 seconds.

Remember to read the full Instructions for Use and Prescribing Information for BYDUREON BCise for complete instructions.

  • Only pressure-activated device with no button required for T2D
  • Only T2D device with no titration and no doses to dial
  • Pre-attached hidden needle

Easy-to-use* device with once-weekly exenatide inside.2

*In a human factor validation study, most participants, 89 of 104 (85.5%), rated the complete overall injection task as either "easy" or "very easy."2

Storage and handling1

Storage and handling1

  • Store flat in the refrigerator at 36°F to 46°F (2°C to 8°C), or

  • Store flat at room temperature (up to 86°F) for up to 4 weeks

  • Do not freeze or use BYDUREON BCise if it has been frozen

  • Protect BYDUREON BCise from light

Safe disposal of used sharps is important. Help your patients learn more about safe sharps disposal.

SAVINGS CARD
DISCOVER ONCE-WEEKLY BYDUREON BCise
SEE THE SAFETY PROFILE OF BYDUREON BCise
EXPERIENCE WHAT'S INSIDE BYDUREON BCise

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IMPORTANT SAFETY INFORMATION

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WARNING: 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. It is unknown whether BYDUREON or BYDUREON BCise cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined

  • BYDUREON and BYDUREON BCise are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of BYDUREON or BYDUREON BCise 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 with BYDUREON or BYDUREON BCise

CONTRAINDICATIONS

  • Personal or family history of MTC, patients with MEN 2

  • Prior serious hypersensitivity reactions to exenatide or product components

  • History of drug-induced, immune-mediated thrombocytopenia from exenatide products

WARNINGS AND PRECAUTIONS

  • Never share a BYDUREON pen or needle with anyone else Sharing poses a risk for transmission of blood-borne pathogens

  • Acute Pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported. After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis

  • Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues. Consider lowering the dose of these agents when coadministered with BYDUREON or BYDUREON BCise

  • Acute Kidney Injury May induce nausea and vomiting with transient hypovolemia and may worsen renal function. Increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported. Not recommended in patients with eGFR <45 mL/min/1.73 m2

  • Gastrointestinal Disease Because exenatide is commonly associated with gastrointestinal adverse reactions, not recommended in patients with severe gastrointestinal disease (eg, gastroparesis)

  • Immunogenicity Patients may develop antibodies to exenatide. Patients with higher titer antibodies may have an attenuated HbA1c response. In clinical trials, attenuated glycemic response was associated with BYDUREON- or BYDUREON BCise-treated patients. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy

  • Hypersensitivity Reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYDUREON or BYDUREON BCise and promptly seek medical advice

  • Drug-induced, immune-mediated thrombocytopenia and associated bleeding has been reported with exenatide. Serious bleeding, which may be fatal, has been reported. Discontinue promptly if suspected and avoid re-exposure to exenatide

  • Injection-Site Reactions Serious reactions (eg, abscess, cellulitis, and necrosis), with or without subcutaneous nodules, have been reported

  • Acute Gallbladder Disease has been reported in GLP-1 receptor agonist trials, including exenatide. If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated

ADVERSE REACTIONS

  • Most common (≥5%) and occurring more frequently than comparator in BYDUREON clinical trials: nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), dyspepsia (5.1%)

  • Most common (≥5%) in BYDUREON BCise clinical trials: injection-site nodule (10.5%), nausea (8.2%)

DRUG INTERACTIONS

  • Oral Medications BYDUREON and BYDUREON BCise slow gastric emptying and may reduce the rate of absorption of orally administered drugs

  • Warfarin Increased international normalized ratio (INR) sometimes associated with bleeding has been reported with concomitant use of exenatide with warfarin. Monitor INR frequently until stable upon initiation of BYDUREON or BYDUREON BCise

PREGNANCY

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

INDICATION AND LIMITATIONS OF USE

BYDUREON and BYDUREON BCise are both indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

  • Not recommended as first-line therapy for patients inadequately controlled on diet and exercise

  • Not a substitute for insulin. Should not be used to treat type 1 diabetes or diabetic ketoacidosis

  • Not studied with prandial insulin

  • Do not coadminister with other exenatide-containing products

  • Not studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis

You may report side effects related to AstraZeneca products by clicking here.

Please see full Prescribing Information, including Boxed WARNINGS, for BYDUREON, and BYDUREON BCise.

WARNING: 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. It is unknown whether BYDUREON or BYDUREON BCise cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined

  • BYDUREON and BYDUREON BCise are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of BYDUREON or BYDUREON BCise 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 with BYDUREON or BYDUREON BCise

CONTRAINDICATIONS

  • For BYDUREON and BYDUREON BCise: Personal or family history of MTC, patients with MEN 2

  • Prior serious hypersensitivity reactions to exenatide or product components

  • History of drug-induced, immune-mediated thrombocytopenia from exenatide products

WARNINGS AND PRECAUTIONS

  • Acute Pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been reported. After initiation, observe patients carefully for symptoms of pancreatitis. If suspected, discontinue promptly and do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis

  • Never Share Injection Device or Needle Between Patients Sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed

  • Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadministered with insulin or insulin secretagogues. Consider lowering the dose of these agents when coadministered with BYDUREON, BYDUREON BCise or BYETTA

  • Acute Kidney Injury May induce nausea and vomiting with transient hypovolemia and may worsen renal function. Altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation have been reported. BYDUREON or BYDUREON BCise are not recommended in patients with eGFR <45 mL/min/1.73 m2.  BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with moderate renal impairment or renal transplantation

  • Gastrointestinal Disease Because exenatide is commonly associated with gastrointestinal adverse reactions, not recommended in patients with severe gastrointestinal disease (eg, gastroparesis)

  • Immunogenicity Patients may develop antibodies to exenatide. Patients with higher titer antibodies may have an attenuated HbA1c response. In clinical trials, attenuated glycemic response was associated with BYDUREON-, BYDUREON BCise-, or BYETTA-treated patients. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy

  • Hypersensitivity Reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYDUREON, BYDUREON BCise or BYETTA and promptly seek medical advice

  • Drug-induced, immune-mediated thrombocytopenia and associated bleeding have been reported with exenatide. Serious bleeding associated with profound thrombocytopenia may be potentially fatal. Discontinue promptly if suspected and avoid re-exposure to exenatide

  • Injection-Site Reactions Serious reactions (eg, abscess, cellulitis, and necrosis), with or without subcutaneous nodules, have been reported with extended-release exenatide

  • Acute Gallbladder Disease has been reported in GLP-1 receptor agonist trials, including exenatide. If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated

ADVERSE REACTIONS

  • Most common (≥5%) and occurring more frequently than comparator in BYDUREON clinical trials: nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), dyspepsia (5.1%)

  • Most common (≥5%) in BYDUREON BCise clinical trials: injection-site nodule (10.5%), nausea (8.2%)

  • Most common (≥5%) and occurring more frequently than placebo in BYETTA clinical trials: nausea (8%-44%), hypoglycemia (3.8%-35.7%), vomiting (4%-18%), diarrhea (6%-18%), feeling jittery (9%), dizziness (9%), headache (9%-14%), dyspepsia (3%-7%), constipation (10%), asthenia (4%-5%)

DRUG INTERACTIONS

  • Oral Medications BYDUREON, BYDUREON BCise and BYETTA slow gastric emptying and may reduce the rate of absorption of orally administered drugs

  • Warfarin Increased international normalized ratio (INR) sometimes associated with bleeding has been reported with concomitant use of exenatide with warfarin. Monitor INR frequently until stable upon initiation of BYDUREON, BYDUREON BCise, or BYETTA

PREGNANCY

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

INDICATION AND LIMITATIONS OF USE

BYDUREON, BYDUREON BCise and BYETTA are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

  • BYDUREON or BYDUREON BCise is not recommended as first-line therapy for patients inadequately controlled on diet and exercise

  • BYDUREON, BYDUREON BCise or BYETTA is not a substitute for insulin. Should not be used to treat type 1 diabetes or diabetic ketoacidosis

  • Not studied with prandial insulin

  • Do not coadminister with other exenatide-containing products

  • Not studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis

You may report side effects related to AstraZeneca products by clicking here.

Please see full Prescribing Information, including Boxed WARNINGS, for BYDUREON and BYDUREON BCise, and full Prescribing Information for BYETTA.

Abbreviations: GLP-1 RA, glucagon-like peptide-1 receptor agonist; T2D, type 2 diabetes.

References:

  1. BYDUREON BCise® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  2. Data on file, REF-14053, AstraZeneca Pharmaceuticals LP.

Abbreviations: FDA, US Food and Drug Administration; GLP-1 RA, glucagon-like peptide-1 receptor agonist.

References:

  1. BYETTA® ([exenatide] injection) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  2. BYDUREON® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  3. BYDUREON BCise® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  4. Data on file, REF-14053, AstraZeneca Pharmaceuticals LP.

  5. Data on file, REF-33646, AstraZeneca Pharmaceuticals LP.

  6. Data on file, US-27454, IQVIA NPA data from 02/2012-01/2019, AstraZeneca Pharmaceuticals LP.

Abbreviations: AACE, American Association of Clinical Endocrinologists; GLP-1 RA, glucagon-like peptide-1 receptor agonist; T2D, type 2 diabetes.

References:

  1. Bunck MC, Diamant M, Cornér A, et al. One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2009;32(5):762-768.

  2. Bunck MC, Corner A, Eliasson B, et al. Effects of exenatide on measures of beta-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care. 2011;34(9):2041-2047.

  3. DeFronzo RA. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58(4):773-795.

  4. BYDUREON® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  5. BYETTA® ([exenatide] injection) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  6. Van Bloemendaal L, IJzerman RG, Ten Kulve JS, et al. GLP-1 receptor activation modulates appetite- and reward-related brain areas in humans. Diabetes. 2014;63(12):4186-4196.

  7. Larsson H, Holst JJ, Ahrén B. Glucagon-like peptide-1 reduces hepatic glucose production indirectly through insulin and glucagon in humans. Acta Physiol Scand. 1997;160(4):413-422.

  8. Campbell JE, Drucker DJ. Pharmacology, physiology, and mechanisms of incretin hormone action. Cell Metab. 2013;17(6):819-837.

  9. DeFronzo RA, Eldor R, Abdul-Ghani M. Pathophysiologic approach to therapy in patients with newly diagnosed type 2 diabetes. Diabetes Care. 2013;36(suppl 2):S127-S138.

  10. Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2018 executive summary. Endocr Pract. 2018;24(1):91-120.

  11. Aronoff SL, Berkowitz K, Shreiner B, Want L. Glucose metabolism and regulation: beyond insulin and glucagon. Diabetes Spectrum. 2004;17(3):183-190.

  12. Prasad-Reddy L, Isaacs D. A clinical review of GLP-1 receptor agonists: efficacy and safety in diabetes and beyond. Drugs Context. 2015;4:212283. doi:10.7573/dic.212283. Accessed April 19, 2018.

Abbreviations: BL, baseline; GLP-1 RA, glucagon-like peptide-1 receptor agonist; PK, pharmacokinetic; T2D, type 2 diabetes.

References:

  1. BYDUREON BCise® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  2. Data on file, REF-14053, AstraZeneca Pharmaceuticals LP.

Reference:

  1. DeYoung MB, MacConell L, Sarin V, Trautmann M, Herbert P. Encapsulation of exenatide in poly-(D,L-lactide-co-glycolide) microspheres produced an investigational long-acting once-weekly formulation for type 2 diabetes. Diabetes Technol Ther. 2011;13(11):1145-1154.

Abbreviations: FPG, fasting plasma glucose; PK, pharmacokinetic.

References:

  1. BYDUREON BCise® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  2. Data on file, REF-19541, AstraZeneca Pharmaceuticals LP.

  3. Wysham CH, Rosenstock J, Vetter M, Dong F, Öhman P, Iqbal N. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Diabetes Obes Metab. 2018;20(1):165-172.

Abbreviations: BID, twice daily; BL, baseline; ITT, intent-to-treat; LSM, least-squares mean; QD, once daily; QW, once weekly; SU, sulfonylurea; T2D, type 2 diabetes; TZD, thiazolidinedione.

References:

  1. BYDUREON BCise® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  2. Data on file, REF-22126, AstraZeneca Pharmaceuticals LP.

  3. Gadde KM, Vetter ML, Iqbal N, Hardy E, Öhman P; for the DURATION-NEO-2 study investigators. Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: the DURATION-NEO-2 randomized clinical study. Diabetes Obes Metab. 2017;19(7):979-988.

  4. Diamant M, Van Gaal L, Stranks S, et al. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010;375(9733):2234-2243.

  5. Bergenstal RM, Wysham C, MacConell L, et al; for the DURATION-2 Study Group. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet. 2010;376(9739):431-439.

  6. Russell-Jones D, Cuddihy RM, Hanefeld M, et al; on behalf of the DURATION-4 Study Group. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012;35(2):252-258.

  7. Blevins T, Pullman J, Malloy J, et al. DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011;96(5):1301-1310.

  8. Wysham CH, Rosenstock J, Vetter M, Dong F, Öhman P, Iqbal N. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Diabetes Obes Metab. 2018;20(1):165-172.

Abbreviations: AE, adverse event; BID, twice daily; GLP-1 RA, glucagon-like peptide-1 receptor agonist; ITT, intent-to-treat; QW, once weekly; SU, sulfonylurea; T2D, type 2 diabetes; TZD, thiazolidinedione.

References:

  1. Data on File, US-27454, IQVIA NPA data from 02/2012-01/2019, AstraZeneca Pharmaceuticals LP.

  2. BYDUREON BCise® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  3. DeYoung MB, MacConell L, Sarin V, Trautmann M, Herbert P. Encapsulation of exenatide in poly-(D,L-lactide-co-glycolide) microspheres produced an investigational long-acting once-weekly formulation for type 2 diabetes. Diabetes Technol Ther. 2011;13(11):1145-1154.

  4. BYDUREON® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  5. Data on file, RE-5087, AstraZeneca Pharmaceuticals LP.

  6. Wysham CH, Rosenstock J, Vetter M, Dong F, Öhman P, Iqbal N. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Diabetes Obes Metab. 2018;20(1):165-172.

Abbreviation: T2D, type 2 diabetes.

References:

  1. BYDUREON BCise® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  2. Data on file, REF-14053, AstraZeneca Pharmaceuticals LP.

Abbreviations: CGM, continuous glucose monitoring; FPG, fasting plasma glucose; MET, metformin; mITT, modified intent-to-treat; MXR, metformin extended-release; PPG, postprandial glucose.

References:

  1. Data on file, REF-5039. AstraZeneca Pharmaceuticals LP.

  2. Frias JP, Nakhle S, Ruggles JA, et al. Exenatide once weekly improved 24-hour glucose control and reduced glycaemic variability in metformin-treated participants with type 2 diabetes: a randomized, placebo-controlled trial [published online ahead of print August 16, 2016]. Diabetes Obes Metab. doi:10.1111/dom.12763.

Abbreviations: BL, baseline; IG, insulin glargine; LS, least squares; MET, metformin; SU, sulfonylurea; TZD, thiazolidinediones.

References:

  1. BYDUREON® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  2. Diamant M, Van Gaal L, Stranks S, et al. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010;375(9733):2234-2243.

  3. Frías JP, Guja C, Hardy E, et al. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2016;4(12):1004-1016.

Abbreviations: BID, twice daily; IU, international unit; QW, once weekly.

References:

  1. BYDUREON® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  2. Data on file, REF-7842. AstraZeneca Pharmaceuticals LP.

  3. Drucker DJ, Buse JB, Taylor K, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008;372(9645):1240-1250.

  4. Wysham CH, Philis-Tsimikas A, Klein EJ, et al. DURATION-1 extension in patients with type 2 diabetes: efficacy and tolerability of exenatide once weekly over 7 years [poster]. Presented at: 76th Annual Scientific Sessions of American Diabetes Association; June 10-14, 2016; New Orleans, LA. Poster 1041-P.

  5. Diamant M, Van Gaal L, Guerci B, et al. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014;2(6):464-473.

  6. Data on file, REF-5090. AstraZeneca Pharmaceuticals LP.

  7. Data on file, REF-4977. AstraZeneca Pharmaceuticals LP.

Abbreviations: PK, pharmacokinetics.

Reference:

  1. BYDUREON® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

Reference:

  1. BYDUREON BCise® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

Reference:

  1. BYDUREON BCise® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

Abbreviations: BL, baseline; CV, cardiovascular; GLP-1 RA, glucagon-like peptide-1 receptor agonist; T2D, type 2 diabetes.

References:

  1. BYDUREON BCise® ([exenatide extended-release] injectable suspension) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.

  2. Holman RR, Bethel MA, Mentz RJ, et al. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2017;377(13):1228-1239.