Generic Name: Exenatide
Class: Incretin Mimetics
Molecular Formula: C184H282N50O60S
CAS Number: 141732-76-5

Warning(s)

REMS:

FDA approved a REMS for exenatide to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of exenatide and consists of the following: communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antidiabetic agent; synthetic, human glucagon-like peptide-1 (GLP-1) receptor agonist (incretin mimetic).1 2 3 4

Uses for Byetta

Diabetes Mellitus

Used as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.1

Has been used in combination with metformin, a sulfonylurea, or a thiazolidinedione; in combination with metformin and a sulfonylurea or thiazolidinedione; or in combination with insulin glargine with or without metformin and/or a thiazolidinedione, as an adjunct to diet and exercise for the management of type 2 diabetes mellitus.1 16 23 (See Use with Drugs Known to Cause Hypoglycemia under Cautions.)

Slideshow: Can Prescription Drugs Lead to Weight Gain?

Not a substitute for insulin.1

Do not use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis; not effective for these conditions.1

Safety and efficacy of exenatide in combination with prandial insulin not established; concomitant use not recommended.1

Byetta Dosage and Administration

Administration

Administer by sub-Q injection using the prefilled injection pen.1 No data available on safety or efficacy of IV or IM administration.1

Do not mix with insulin.1

Do not transfer from injection pen to syringe or vial.1

Sub-Q Administration

Administer by sub-Q injection twice daily, prior to (i.e., within 60 minutes of) morning and evening meals.1 14

Alternatively, administer before 2 main meals of the day, approximately ≥6 hours apart.1 14

Do not administer after a meal.1 14

Administer into the abdomen, thigh, or upper arm.1

Dosage

If used in combination with a sulfonylurea, reduction of sulfonylurea dosage may be required.1 (See Use with Drugs Known to Cause Hypoglycemia under Cautions.)

If used in combination with insulin, evaluate insulin dosage; consider reduction of insulin dosage in patients at increased risk of hypoglycemia.1 In a clinical trial, dosage of concomitant insulin glargine reduced by 20% in exenatide-treated patients with HbA1c concentrations ≤8%; 1 23 relative safety and efficacy of this approach may not apply to patients with baseline HbA1c concentrations <7%, those with a recent history of major hypoglycemia, or those receiving long-acting GLP-1 receptor agonists.23 (See Use with Drugs Known to Cause Hypoglycemia under Cautions.)

Adults

Diabetes Mellitus
Sub-Q

Initially, 5 mcg twice daily.1 14 If needed, may increase to 10 mcg twice daily after 1 month.1

Special Populations

Hepatic Impairment

Dosage adjustment not required.1 14

Renal Impairment

Mild renal impairment (Clcr 50–80 mL/minute): No dosage adjustment required.1 9 12

Moderate renal impairment (Clcr 30–50 mL/minute): Use caution when initiating exenatide or increasing dosage from 5 mcg twice daily to 10 mcg twice daily.1 14 21

End-stage renal disease (ESRD) or severe renal impairment (Clcr <30 mL/minute): Do not use.1 9 12 21 Use with caution in patients who have undergone renal transplantation.1 (See Renal Effects under Cautions.)

Geriatric Patients

Careful dosage selection recommended due to possible age-related decrease in renal function and concomitant disease and drug therapy; however, dosage requirements generally similar in geriatric patients and younger adults.1

Obese Patients

Dosage adjustment not required.1

Cautions for Byetta

Contraindications

Known hypersensitivity to exenatide or any ingredient in the formulation.1

Warnings/Precautions

Pancreatitis and Precancerous Changes

Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis requiring hospitalization, reported.1 17 20

Persistent, severe abdominal pain, which sometimes radiates to the back and may be accompanied by vomiting, is the hallmark symptom of acute pancreatitis.1

Most patients who developed pancreatitis had at least one other risk factor for acute pancreatitis (e.g., gallstones, severe hypertriglyceridemia, alcohol use) and required hospitalization.17

Serious complications include dehydration and renal failure, suspected ileus, phlegmon, and ascites; most patients have improved upon discontinuance of exenatide.17

After initiation of exenatide, and after increases in dosage, carefully observe patients for signs and symptoms of acute pancreatitis (e.g., unexplained, persistent, severe abdominal pain that may radiate to the back; nausea; vomiting; elevated serum amylase or lipase concentrations).1 17

FDA is evaluating unpublished findings suggesting an increased risk of pancreatitis and precancerous cellular changes in patients with type 2 diabetes mellitus receiving incretin mimetics.36 37 FDA has not yet reached any new conclusions about safety risks with incretin mimetics.36 FDA will notify healthcare professionals of its conclusions and recommendations when the review is complete, or when the agency has additional information to report.36

FDA states that at this time clinicians should continue to follow the recommendations in the prescribing information for incretin mimetics.36 The manufacturer states that if pancreatitis is suspected, promptly discontinue therapy with exenatide and other potentially suspected drugs, perform confirmatory tests (e.g., serum amylase or lipase concentrations, radiologic imaging), and initiate appropriate therapy.1 17 20

Do not resume exenatide if pancreatitis confirmed.1

Not studied in patients with a history of pancreatitis; consider other antidiabetic therapies in such patients.1

Use with Drugs Known to Cause Hypoglycemia

Increased risk of hypoglycemia with concomitant sulfonylurea therapy; may require reduction of sulfonylurea dosage.1

If used in combination with insulin, consider reduction of insulin dosage in patients at increased risk of hypoglycemia.1 (See Dosage under Dosage and Administration.) Safety and efficacy of exenatide in combination with prandial insulin not established; concomitant use not recommended.1

Concomitant use with other glucose-independent insulin secretagogues (e.g., meglitinides) may increase risk of hypoglycemia.1

Renal Effects

Deterioration of renal function (e.g., increased Scr, renal impairment/insufficiency, worsened chronic renal failure, acute renal failure sometimes requiring hemodialysis or kidney transplantation) reported rarely.1 21 In some patients, presence of other factors (nausea, vomiting, and/or diarrhea with or without dehydration; concomitant use of other agents known to affect renal function or hydration status [e.g., ACE inhibitors, NSAIAs, diuretics])1 21 may have contributed to development of altered renal function.21

Exenatide has not been found to be directly nephrotoxic in preclinical or clinical studies.1

Altered renal function may be a consequence of diabetes mellitus, independent of any risk associated with exenatide.21

Closely monitor patients for signs and symptoms of renal dysfunction; consider discontinuing exenatide if renal dysfunction suspected and cannot be explained by other causes.21 Renal effects usually reversible with supportive treatment and discontinuance of potentially causative agents, including exenatide.1 (See Renal Impairment under Cautions and also see Renal Impairment under Dosage and Administration.)

GI Effects

Adverse GI effects (e.g., nausea, vomiting, diarrhea) reported commonly.1 Use not recommended in patients with severe GI disease (e.g., gastroparesis).1 14

Immunogenicity

Development of antibodies to exenatide reported.1 3 9 Antibody formation associated with attenuated glycemic response in some patients.1 14

Treatment-emergent cross-reactive antibodies to GLP-1 and/or glucagon not observed in a group of patients with anti-exenatide antibodies in clinical trials.1

If worsening glycemic control or failure to achieve targeted glycemic control occurs, consider alternative antidiabetic therapy.1

Sensitivity Reactions

Generalized pruritus and/or urticaria, macular or papular rash, and angioedema reported during postmarketing experience.1 Anaphylactic reaction reported rarely.1

Macrovascular Outcomes

Evidence of macrovascular risk reduction with exenatide or any other antidiabetic agent not conclusively demonstrated in controlled clinical trials.1

Specific Populations

Pregnancy

Category C.1

Pregnancy registry at 800-633-9081.1

Lactation

Distributed into milk in mice; not known whether distributed into human milk.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established in children <17 years of age.1 14

Geriatric Use

No substantial differences in safety and efficacy nor in pharmacokinetics relative to younger adults.1 9

Hepatic Impairment

Pharmacokinetics not evaluated, but impact of hepatic impairment should be minimal.1 14

Renal Impairment

Decreased clearance in patients with ESRD receiving dialysis; possible decreased tolerance to therapy due to adverse GI effects.1 12 Use not recommended in patients with ESRD or severe renal impairment (Clcr <30 mL/minute); use with caution in patients who have undergone renal transplantation.1 9 21 (See Renal Effects under Cautions.)

No dosage adjustment required in patients with mild renal impairment (Clcr 50–80 mL/minute).1 9 12

Use caution when initiating exenatide or increasing dosage from 5 mcg twice daily to 10 mcg twice daily in patients with moderate renal impairment (Clcr 30–50 mL/minute).1 14 21 (See Renal Effects under Cautions and also see Special Populations under Pharmacokinetics.)

Common Adverse Effects

Monotherapy: Hypoglycemia, nausea, vomiting, dyspepsia.1

Combination therapy with metformin and/or a sulfonylurea: Hypoglycemia nausea, vomiting, diarrhea, jittery feeling, dizziness, headache, dyspepsia, asthenia, GERD, hyperHIDrosis.1

Combination therapy with a thiazolidinedione with or without metformin: Hypoglycemia, nausea, vomiting, dyspepsia, diarrhea, GERD.1

Combination therapy with insulin glargine with or without metformin and/or a thiazolidinedione: Hypoglycemia, nausea, vomiting, diarrhea, headache, constipation, dyspepsia, asthenia, abdominal distention, decreased appetite, flatulence, GERD.1

Interactions for Byetta

GI Absorption of Other Drugs

Possible decreased rate and extent of absorption of concomitantly administered oral drugs; use with caution with oral drugs that have a narrow therapeutic index or require rapid GI absorption.1

Administer oral drugs for which efficacy depends on threshold concentrations ≥1 hour before exenatide administration.1 9 If such drugs need to be administered with food, administer them with a meal or snack (e.g., lunch) at a time when exenatide is not administered.1

Specific Drugs

Drug

Interaction

Comments

Acetaminophen

Decreased AUC and peak plasma concentration and increased time to peak plasma concentration of acetaminophen when acetaminophen administered simultaneously with or at 1, 2, or 4 hours after exenatide1 11

Acetaminophen AUC, peak plasma concentration, and time to peak plasma concentration not appreciably changed when acetaminophen administered 1 hour before exenatide1 11

Antidiabetic agents

Sulfonylureas: Increased risk of hypoglycemia1

Prandial insulin: Safety and efficacy of concomitant use not established1

Other glucose-independent insulin secretagogues (e.g., meglitinides): Possible increased risk of hypoglycemia1

Sulfonylureas: Consider reduction of sulfonylurea dosage1

Insulin: Consider reduction insulin dosage in patients at increased risk of hypoglycemia1

Prandial insulin: Concomitant use not recommended1

Anti-infective agents, oral

Possible decreased rate and extent of anti-infective absorption1 9

Administer oral anti-infective ≥1 hour before exenatide1 9

Digoxin

Decreased peak plasma concentration and delayed time to peak concentration of digoxin when exenatide administered 30 minutes before digoxin; no change in digoxin steady-state AUC and renal clearance1 9 10

Lisinopril

Delayed steady-state time to peak plasma lisinopril concentrations; no change in steady-state AUC or peak plasma lisinopril concentrations or in mean 24-hour SBP and DBP 1 9 13

Lovastatin

Decreased AUC and peak plasma concentration and delayed time to peak plasma concentration of lovastatin when exenatide administered 30 minutes before lovastatin; no consistent changes in lipid profiles1 9

Oral contraceptives

Decreased peak plasma concentration and delayed time to peak plasma concentration of ethinyl estradiol and levonorgestrel when administered as fixed-combination oral contraceptive 30 minutes after exenatide1

Decreased mean peak plasma concentration of ethinyl estradiol when administered as fixed-combination oral contraceptive 1 hour before exenatide; mean peak plasma levonorgestrel concentration not substantially changed1

Increased mean trough concentration of ethinyl estradiol when fixed-combination oral contraceptive administered 30 minutes after exenatide; mean trough concentrations of levonorgestrel not altered1

Effect of exenatide on pharmacokinetics of oral contraceptives confounded by possible effect of food on oral contraceptives1

Administer oral contraceptive ≥1 hour before exenatide1

Warfarin

Increased INR, sometimes associated with bleeding, reported1

Delayed time to peak plasma concentration of warfarin; no clinically important change in AUC or peak plasma warfarin concentrations1

Monitor PT more frequently after initiating or altering exenatide therapy; once a stable PT achieved, PT may be monitored at intervals usually recommended for patients receiving warfarin1

Byetta Pharmacokinetics

Manufacturer states pharmacokinetics are independent of dose, age, gender, race, and patient weight.1

Absorption

Bioavailability

Following sub-Q administration, peak plasma concentration usually attained in 2.1 hours.1

Absorption is similar when injected into abdomen, thigh, or arm.1

Distribution

Extent

Distributed into milk in mice; not known whether distributed into human milk.1

Elimination

Metabolism

Primarily proteolytic degradation after glomerular filtration.1

Elimination Route

Excreted principally in urine.1

Half-life

2.4 hours.1

Special Populations

Decreased clearance in patients with ESRD receiving dialysis.1 Exposure to exenatide in patients with mild to moderate renal impairment (Clcr 30–80 mL/minute) similar to that in individuals with normal renal function.1 (See Renal Effects under Cautions.)

Stability

Storage

Parenteral

Solution for Injection

Before use, 2–8°C.1 After first use, ≤25ºC.1 Do not freeze; protect from light.1 Discard pen 30 days after first use.1

Actions

  • A synthetic analog of a naturally occurring peptide isolated from the saliva of Heloderma suspectum (Gila monster); is a glucagon-like peptide-1 (GLP-1) mimetic (incretin mimetic).1 2 3 4 5 6 8

  • Structurally and pharmacologically unrelated to insulin, sulfonylureas, meglitinides, biguanides, thiazolidinediones, and α-glucosidase inhibitors.1

  • Lowers fasting and postprandial glucose concentrations in patients with type 2 diabetes mellitus.1 2 3 8

  • Improves pancreatic β-cell function by increasing glucose-dependent insulin synthesis, secretion and acute β-cell responsiveness (i.e., first phase insulin response).1 2 3 4 8 14

  • Inhibits inappropriately high glucagon secretion (e.g., after a meal) in patients with type 2 diabetes mellitus1 3 8 but does not impair normal glucagon response to hypoglycemia.1

  • Slows gastric emptying, which reduces the rate of glucose absorption from a meal and reduces food intake.1 2 5 6 8

  • Does not appear to be associated with clinically important prolongation of the corrected QT interval (QTc, Bazett's formula).1

Advice to Patients

  • Importance of patient reading medication guide and the injection per user guide before initiating therapy and each time drug is dispensed.1 22

  • Importance of informing patients regarding potential risks and advantages of exenatide therapy.1 22 Importance of not using exenatide in patients with type 1 diabetes mellitus or diabetic ketoacidosis.1 22

  • Importance of providing instruction regarding recognition and management of hypoglycemia and hyperglycemia, and assessment of other diabetes complications.1 22

  • Importance of informing patient about possibility of acute pancreatitis, which may be severe or fatal, with exenatide therapy.1 22 Importance of patient informing clinicians about a history of pancreatitis, gallstones, alcoholism, or high triglyceride levels.1 22 Importance of patients discontinuing exenatide and promptly informing clinician if unexplained, persistent, severe abdominal pain that may radiate to the back and may or may not be accompanied by nausea and vomiting occurs.1 17 22 If pancreatitis is suspected, discontinue exenatide; do not restart if pancreatitis confirmed.1 17 22

  • Importance of informing patients about risk of altered renal function while considering clinical usefulness of exenatide, risks and benefits of other antidiabetic therapies, and risks associated with uncontrolled diabetes mellitus.21 22 Importance of informing patients about signs and symptoms of altered renal function (e.g., increased Scr; changes in color, frequency, amount of urination; unexplained swelling in extremities; increases in BP; lethargy; changes in appetite or digestion; dull ache in the middle to lower back).1 21 Importance of patient informing clinician about development of nausea, vomiting, or dehydration, which may contribute to altered renal function.21 22 Importance of informing patients that chronic conditions such as hypertension or pancreatitis and concomitant therapy with NSAIAs, diuretics, or antihypertensive agents can increase the risk of developing altered renal function with exenatide therapy.21 22

  • Importance of discontinuing exenatide and other suspect drugs and seeking medical attention promptly if hypersensitivity reactions (e.g., anaphylaxis, angioedema) occur.1 22

  • Increased risk of hypoglycemia when exenatide is used with a sulfonylurea;1 22 lower sulfonylurea dosage may be required to reduce risk of hypoglycemia.1 22 Increased risk of hypoglycemia also possible when exenatide is used with other glucose-independent insulin secretagogues (e.g., meglitinides).1 22

  • Importance of informing patients that dosage of concomitant insulin may need to be reduced in those at increased risk of hypoglycemia.1 22 Importance of informing patients that use of exenatide in combination with prandial insulin has not been studied and is not recommended.1 22

  • Importance of reviewing with patients the symptoms, treatment, and conditions that predispose to development of hypoglycemia when initiating exenatide treatment, especially when exenatide is used with a sulfonylurea or insulin.1 22

  • Importance of promptly contacting a clinician or poison control center if recommended exenatide dosage is exceeded.22

  • Importance of informing patients that reduced appetite, food intake, and/or body weight may occur but do not require modification of dosage regimen.1 22 Importance of informing patient about occurrence of nausea, particularly upon initiation of exenatide therapy.1 22

  • Importance of informing patients regarding the timing of administration of concomitant oral drugs (e.g., oral contraceptives, anti-infective agents) because of exenatide-induced slowing of gastric emptying.1 22 (See Interactions.)

  • Importance of instructing patients regarding self-monitoring of blood glucose, periodic HbA1c monitoring, adherence to meal planning, and regular physical exercise.1 22

  • Importance of instructing patients regarding injection technique.1 22 Importance of administering exenatide as a sub-Q injection in the thigh, abdomen, or upper arm within 60 minutes prior to the morning and evening meals, not after a meal.1 22 Importance of not mixing exenatide with insulin1 22 and of not transferring exenatide from the injection pen to a syringe or vial.1

  • Importance of advising patients that if a dose is missed, the treatment regimen should be resumed as prescribed with the next scheduled dose.1 22

  • Importance of instructing patients on proper use and storage of the injection pen, including proper disposal of such equipment using puncture-resistant containers, and of not reusing or sharing the pen or needles, how and when to set up a new pen, and that only one setup step is necessary at initial use.1 22 Importance of storing exenatide refrigerated at 2–8°C before first use and storing at 25°C or cooler after first use; the drug should be protected from light.1 22 Importance of discarding injection pen 30 days after first use, even if some drug remains in the pen.1 22 Importance of not using exenatide if the drug has been frozen,1 22 if particles appear in the solution, or if the solution is cloudy or colored.1 22

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 22

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 21 22

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Exenatide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use

250 mcg/mL

Byetta (available as prefilled cartridge pen)

Amylin

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Bydureon 2MG Suspension (AMYLIN PHARMACEUTICALS): 4/$375.99 or 8/$751.98

Byetta 10 MCG Pen 10MCG/0.04ML Solution (AMYLIN PHARMACEUTICALS): 2/$281.98 or 7/$825.01

Byetta 5 MCG Pen 5MCG/0.02ML Solution (AMYLIN PHARMACEUTICALS): 1/$337.00 or 4/$935.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions November 26, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Amylin Pharmaceuticals. Byetta (exenatide) injection prescribing information. San Diego, CA; 2013 Feb.

2. Scott V, Rodgers PT, Scates AC. Incretin mimetics as emerging treatments for type 2 diabetes. Ann Pharmacother. 2005; 39:110-8. [IDIS 534323] [PubMed 15562141]

3. Buse JB, Henry RR, Hans J et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 2004; 27:2628-35. [IDIS 534649] [PubMed 15504997]

4. Nuack MA. Glucagon-like peptide (GLP-1): a promising approach and a novel treatment for patients with type 2 diabetes. Int J Clin Pract. S138:45-52.

5. Kendall DM, Riddle MC, Rosenstock J et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005; 28:1083-91. [IDIS 538293] [PubMed 15855571]

6. Defronzo RA, Ratner RE, Han J et al. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005; 28:1092-100. [IDIS 538294] [PubMed 15855572]

8. Kolterman OG, Kim DD, Shen L et al. Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus. Am J Health- Syst Pharm. 2005; 62:173-81. [IDIS 538343] [PubMed 15700891]

9. Keating GM. Exenatide. Drugs. 2005; 65(12):1681-92; discussion 1693-5. [PubMed 16060703]

10. Kothare PA, Soon DK, Linnebjerg H et al. Effect of exenatide on the steady-state pharmacokinetics of digoxin. J Clin Pharmacol. 2005; 45(9):1032-7. [PubMed 16100297]

11. Blase E, Taylor K, Gao HY et al. Pharmacokinetics of an oral drug (acetaminophen) administered at various times in relation to subcutaneous injection of exenatide (exendin-4) in healthy subjects. J Clin Pharmacol. 2005; 45(5):570-7. [PubMed 15831781]

12. Linnebjerg H, Hothare P, Park S, et al. Exenatide pharmacokinetics in patients with mild to moderate renal dysfunction and end stage renal disease [abstract no. 469-P]. Diabetes. 2005; 54 (Suppl 1):A116.

13. Kothare P, Linnebjerg H, Atkins M, et al. Effect of exenatide on lisinopril pharmacodynamics in patients treated for hypertension [abstract no. PI-24]. Clin Pharmacol Ther. 2005; 77 (2):P14.

14. Amylin Pharmaceuticals, Inc., San Diego, CA: Personal communication.

15. Degn KB, Brock B, Juhl CB et al. Effect of intravenous infusion of exenatide (synthetic exendin-4) on glucose-dependent insulin secretion and counterregulation during hypoglycemia. Diabetes. 2004; 53:2397-403. [PubMed 15331551]

16. Zinman B, Hoogwerf BJ, Garcia SD et al. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007; 146:477-85. [PubMed 17404349]

17. Food and Drug Administration, Center for Drug Evaluation and Research. FDA alert: Information for healthcare professionals on exenatide (marketed as Byetta). Rockville MD: Food and Drug Administration; 2007 Oct 2. Available from FDA website. Accessed 2007 Nov 2.

18. Jones MC. Therapies for diabetes: pramlintide and exenatide. Am Fam Physician. 2007; 75:1831-5. [PubMed 17619527]

19. Mikhail N. Exenatide: a novel approach for treatment of type 2 diabetes. South Med J. 2006; 99:1271-9. [PubMed 17195423]

20. Food and Drug Administration, Center for Drug Evaluation and Research. FDA alert: Information for healthcare professionals on exenatide (marketed as Byetta). Rockville MD: Food and Drug Administration; 2008 Aug 18. Available from FDA website. Accessed 2008 Oct 10.

21. Food and Drug Administration, Center for Drug Evaluation and Research. FDA alert: Information for healthcare professionals—reports of altered kidney function in patients using exenatide (marketed as Byetta). Rockville MD: Food and Drug Administration; 2009 Nov 2. Available from FDA website. Accessed 2009 Nov 30.

22. Amylin Pharmaceuticals. Byetta (exenatide) injection medication guide. San Diego, CA; 2013 Feb.

23. Buse JB, Bergenstal RM, Glass LC et al. Use of twice-daily exenatide in basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011; 154:103-12. [PubMed 21138825]

36. Food and Drug Administration. Early communication: reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas. Silver Spring, MD; 2013 Mar 14. From FDA website.

37. Singh S, Chang HY, Richards TM et al. Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med. 2013; 173:534-9. [PubMed 23440284]

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