Class: Incretin Mimetics
Molecular Formula: C184H282N50O60S
CAS Number: 141732-76-5
Brands: Byetta, Bydureon
- Thyroid C-cell Tumors
Extended-release exenatide causes thyroid C-cell tumors at clinically relevant exposures in rats.38 Unknown whether the drug causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.38 Extended-release exenatide is contraindicated in patients with a personal or family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2).38
Uses for Exenatide
Exenatide has been used as monotherapy or 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.1 7 16 23
Extended-release exenatide has been used as monotherapy or in combination with metformin, a sulfonylurea, or a thiazolidinedione; in combination with metformin and a sulfonylurea; or in combination with metformin and a thiazolidinedione.38
Once-weekly extended-release exenatide generally as effective for glycemic control as metformin or pioglitazone and more effective than sitagliptin, titrated insulin glargine, insulin detemir, or twice-daily exenatide;39 40 41 42 45 47 51 52 53 54 57 58 60 61 62 such improvements maintained during long-term therapy.39 46 47 48 49 55 56 57 60 61
Extended-release exenatide not recommended as first-line therapy in patients with inadequate glycemic control on diet and exercise because of uncertain relevance to humans of thyroid C-cell tumors found in rodents given the drug.38 (See Boxed Warning.)
Safety and efficacy of exenatide or extended-release exenatide not established in patients with a history of pancreatitis; consider other antidiabetic agents in such patients.1 38 (See Pancreatitis and Pancreatic Precancerous Changes under Cautions.)
Safety and efficacy of exenatide in combination with prandial insulin not established; concomitant use not recommended.1
Safety and efficacy of extended-release exenatide in combination with insulin not established; such concomitant use not recommended.38
Exenatide and extended-release exenatide contain the same active ingredient; do not use both agents concomitantly.38
Exenatide Dosage and Administration
Exenatide and extended-release exenatide intended for self-administration by patient.1 38 Healthcare professionals should instruct patients in preparation and use of drug before first use.1 22 38 69 70
Sub-Q Administration: Exenatide
Do not transfer drug from injection pen to syringe or vial.1
Sub-Q Administration: Extended-release Exenatide
Administer sub-Q into abdomen, thigh, or back of upper arm region using prefilled injection pen; must not administer IV or IM.38 68 69 70 Rotate injection sites with each weekly dose when injecting in the same region.38 68 69 70
If injection pen has been stored in refrigerator, allow pen to stand at room temperature for 15 minutes before reconstitution.69
Reconstituted suspension in injection pen or vial contains 2 mg of extended-release exenatide in 0.65 mL of diluent.38
Reconstituted drug suspension in vial must be transferred to manufacturer-provided syringe before administration.68
If exenatide or extended-release exenatide used in combination with a sulfonylurea, reduction of sulfonylurea dosage may be required.1 22 38 (See Use with Drugs Known to Cause Hypoglycemia under Cautions.)
If exenatide is 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.)
Safety and efficacy of extended-release exenatide and concomitant insulin therapy not established; not recommended by manufacturer.38
Prior treatment with exenatide not required when initiating extended-release exenatide therapy.38
If decision is made to initiate extended-release exenatide in a patient already receiving exenatide, discontinue exenatide.38
Patients changing therapy from exenatide to extended-release exenatide may experience transient (approximately 2 weeks) elevations in blood glucose concentrations.38
Extended-release exenatide: 2 mg once every 7 days (weekly).38
Mild renal impairment (Clcr 50–80 mL/minute): No adjustment of exenatide dosage required.1 9 12 Manufacturer makes no recommendation about modification of extended-release exenatide dosage in patients with mild renal impairment.38
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 Use extended-release exenatide with caution.38
End-stage renal disease (ESRD) or severe renal impairment (Clcr <30 mL/minute): Do not use exenatide or extended-release exenatide.1 9 12 21 38 Use exenatide or extended-release exenatide with caution in patients who have undergone renal transplantation.1 38 (See Renal Effects and also Renal Impairment under Cautions.)
Careful selection of exenatide dosage 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 Use caution when initiating extended-release exenatide in geriatric patients.38
Adjustment of exenatide dosage not required.1
Cautions for Exenatide
Extended-release exenatide: Personal or family history of medullary thyroid carcinoma (MTC) or diagnosis of multiple endocrine neoplasia syndrome type 2 (MEN 2).38
Risk of Thyroid C-cell Tumors with Extended-release Exenatide
Dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in rats.38
Not known whether extended-release exenatide causes thyroid C-cell tumors, including MTC, in humans.38
Refer patients to endocrinologist for further evaluation if thyroid nodules noted on physical examination or neck imaging.38
Although routine monitoring of serum calcitonin or use of thyroid ultrasound for early detection of MTC in patients receiving extended-release exenatide is of uncertain value, refer patient to endocrinologist for further evaluation if serum calcitonin is measured and found to be elevated.38
Other Warnings and Precautions
Pancreatitis and Pancreatic Precancerous Changes
Hallmark symptom of acute pancreatitis is persistent, severe abdominal pain, which sometimes radiates to the back and may be accompanied by vomiting.1 Most patients who developed pancreatitis during exenatide therapy 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 or extended-release 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 38
FDA has been evaluating unpublished findings suggesting an increased risk of pancreatitis and precancerous pancreatic cellular changes in patients with type 2 diabetes mellitus receiving incretin mimetics.36 37 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 has recommended that clinicians 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 or extended-release 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 38
Use with Drugs Known to Cause Hypoglycemia
If exenatide is 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 or of extended-release exenatide with any type of insulin not established; concomitant use not recommended by manufacturer.1 38
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 38 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 38 may have contributed to development of altered renal function.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.)
Adverse GI effects (e.g., nausea, vomiting, diarrhea) reported frequently with exenatide or extended-release exenatide; use not recommended in patients with severe GI disease (e.g., gastroparesis).1 14 38
Serious injection-site reactions (e.g., abscess, cellulitis, necrosis) with or without sub-Q nodules reported in patients receiving extended-release exenatide during postmarketing experience; surgical intervention required in isolated cases.38
Risk Associated with Sharing of Injection Pens
No substantial differences in safety and efficacy nor in pharmacokinetics relative to younger adults.1 9 38 Geriatric patients are more likely to have decreased renal function; use caution when initiating drug in such patients.38
Decreased clearance of exenatide in patients with ESRD receiving dialysis; possible decreased tolerance to therapy due to adverse GI effects.1 12 In such patients, single doses of exenatide 5 mcg were not well tolerated due to adverse GI effects.38 Safety and efficacy of extended-release exenatide not established in patients with ESRD or severe renal impairment.38
Do not use exenatide or extended-release exenatide 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 38
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 Use extended-release exenatide with caution in such patients.38 (See Elimination: Special Populations, under Pharmacokinetics.)
Common Adverse Effects
Exenatide monotherapy or in combination with other oral antidiabetic agents (metformin, a sulfonylurea, and/or a thiazolidinedione) or basal insulin: Hypoglycemia, nausea, vomiting, diarrhea, jittery feeling, dizziness, headache, dyspepsia, asthenia, GERD, hyperhidrosis, constipation, abdominal distention, decreased appetite, flatulence.1
Extended-release exenatide monotherapy or in combination with other oral antidiabetic agents (metformin, a sulfonylurea, and/or a thiazolidinedione): Hypoglycemia, nausea, diarrhea, injection-site reactions (pruritus, nodule, erythema, hematoma), vomiting, constipation, headache, viral gastroenteritis, GERD, dyspepsia, fatigue, decreased appetite.38
Interactions for Exenatide
GI Absorption of Other Drugs
With oral drugs for which efficacy depends on threshold concentrations, administer ≥1 hour before exenatide.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
Exenatide: Decreased AUC and peak plasma concentration and increased time to peak plasma concentration of acetaminophen when administered simultaneously with or at 1, 2, or 4 hours after exenatide1 11
Extended-release exenatide: Acetaminophen AUC not appreciably changed but acetaminophen peak plasma concentration decreased (effect greater in fasting than fed state) and time to peak concentration increased; effects generally less than those observed when acetaminophen given with or 1–4 hours after exenatide1 38 59
Insulin secretagogues, insulin independent
Anti-infective agents, oral
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 38
Exenatide: Increased risk of hypoglycemia with concurrent insulin; safety and efficacy of concurrent prandial insulin not established1
Extended-release exenatide: Safety and efficacy of concurrent insulin not established38
Exenatide: Consider reduced concurrent insulin dosage in patients at increased risk of hypoglycemia; concurrent use of prandial insulin not recommended1
Extended-release exenatide: Concurrent use of insulin not recommended38
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 38
Ethinyl estradiol/levonorgestrel given 30 minutes after exenatide: Decreased peak plasma concentration and delayed time to peak plasma concentration of ethinyl estradiol and levonorgestrel; increased mean trough concentration of ethinyl estradiol; mean trough concentrations of levonorgestrel not altered1 38
Ethinyl estradiol/levonorgestrel given 1 hour before exenatide: Decreased mean peak plasma concentration of ethinyl estradiol; mean peak plasma levonorgestrel concentration not substantially changed1 38
Administer oral contraceptive ≥1 hour before exenatide1
Exenatide: Delayed time to peak plasma concentration of warfarin; no clinically important change in AUC or peak plasma warfarin concentrations or INR; however, some reports of increased INR, sometimes associated with bleeding1 1 38
Extended-release exenatide: Data lacking38
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
Monitor INR more frequently after initiating extended-release exenatide therapy; once a stable INR achieved, INR may be monitored at intervals generally recommended for patients receiving warfarin38
Following sub-Q administration of exenatide, peak plasma concentration usually attained in 2.1 hours.1
Absorption of exenatide is similar when injected into abdomen, thigh, or arm.1
Following sub-Q administration of extended-release exenatide, drug is released from the microspheres over approximately 10 weeks.38 Initial release of surface-bound exenatide is followed by gradual release from microspheres; peak concentrations occur at approximately week 2 and week 6–7.38
Steady-state plasma concentrations achieved 6–7 weeks after weekly (once every 7 days) sub-Q administration of extended-release exenatide.38 Approximately 10 weeks after discontinuance, concentrations generally undetectable.38
Extended-release exenatide: Steady-state concentrations not affected by gender or race.38
Exenatide: 2.4 hours.1
Exenatide: Manufacturer states pharmacokinetics are independent of dose, age, gender, race, and BMI.1
Exenatide: Decreased clearance and increased exposure in patients with ESRD receiving dialysis.1 Exposure 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 Impairment under Cautions.)
Extended-release exenatide: Increased exposure in patients with mild or moderate renal impairment; data lacking in patients with severe renal impairment.38 (See Renal Impairment under Cautions.)
Solution for Injection
Exenatide, 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 38
Structurally and pharmacologically unrelated to insulin, sulfonylureas, meglitinides, biguanides, thiazolidinediones, and α-glucosidase inhibitors.1
Advice to Patients
Importance of instructing patients on proper use and storage of the exenatide or extended-release exenatide injection pen, including proper reconstitution and injection technique to ensure delivery of a full dose, proper disposal of injection pens and needles using puncture-resistant containers, how and when to set up a new injection pen, and that only one setup step is necessary at initial use of exenatide.1 22 38 67 68 69 70
Importance of informing patients regarding potential risks and advantages of exenatide or extended-release exenatide therapy and of alternative modes of therapy.1 22 38 70 Importance of not using exenatide or extended-release exenatide in patients with type 1 diabetes mellitus or diabetic ketoacidosis.1 22 38 70
Importance of providing instruction regarding diabetes self-management practices, such as regular physical activity, adhering to meal planning, periodic blood glucose monitoring, HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment of other diabetic complications.1 22 38
Importance of informing patients that extended-release exenatide causes benign and malignant thyroid C-cell tumors in rats and that the relevance of this finding in humans is unknown.38 70 Importance of not using extended-release exenatide in patients with a personal or family history of medullary thyroid cancer (MTC) or diagnosis of multiple endocrine neoplasia syndrome type 2 (MEN 2).38 70 Importance of advising patients to report symptoms that may be suggestive of thyroid cancer (e.g., lump or swelling in neck, hoarseness, dysphagia, dyspnea).38 70
Importance of patients discontinuing exenatide or extended-release exenatide and other suspect drugs and seeking medical assistance immediately if signs and symptoms of a serious hypersensitivity reaction (e.g., anaphylaxis, angioedema) occur.1 22 38 70 Importance of patients informing their clinician if they have experienced a sensitivity reaction to exenatide or any ingredient in the formulations.1 22 38 70
Importance of informing patient of the potential risk of acute pancreatitis, which may be severe or fatal.1 17 22 38 70 Importance of patient informing clinicians about a history of pancreatitis, gallstones, alcoholism, or high triglyceride levels.1 22 Importance of patients discontinuing exenatide or extended-release 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 38 70 If pancreatitis is suspected, discontinue exenatide or extended-release exenatide; do not restart if pancreatitis confirmed.1 17 22 38 70
Importance of informing patients of the potential risk for worsening renal function and 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 38 70 Importance of patient informing clinician about development of nausea, vomiting, or diarrhea, which may contribute to dehydration and consequent 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
Increased risk of hypoglycemia when exenatide or extended-release exenatide is used with an agent that induces hypoglycemia, such as a sulfonylurea1 22 38 or other glucose-independent insulin secretagogue (e.g., meglitinide);1 22 38 70 lower dosage of sulfonylurea or other insulin secretagogue may be required to reduce risk of hypoglycemia.1 22 38
Importance of reviewing with patients the symptoms, treatment, and conditions that predispose to development of hypoglycemia when initiating exenatide or extended-release exenatide treatment, especially when exenatide is used with a sulfonylurea or insulin; importance of clinician reinforcing instructions for management of hypoglycemia.1 22 38
Importance of advising patient to seek medical advice if symptomatic sub-Q nodules or any signs or symptoms of abscess, cellulitis, or necrosis occur.38
Importance of informing patients that reduced appetite, food intake, and/or body weight may occur with exenatide or extended-release exenatide therapy but do not require modification of dosage regimen.1 22 38 Importance of informing patient about occurrence of nausea, particularly upon initiation of exenatide or extended-release exenatide therapy, and that nausea decreases over time as the drug is continued.1 22 38 70
Importance of informing patients that injection pens should not be shared with another person, even if the needle has been changed.1 22 38 66 69 Such sharing may pose a risk of transmitting or acquiring infection.1 22 38 66 69
Importance of informing patients regarding the timing of exenatide or extended-release exenatide administration with concomitant oral drugs (e.g., oral contraceptives, anti-infective agents) because of slowing of gastric emptying with these exenatide formulations.1 22 38 (See Interactions.)
Importance of informing patient to administer extended-release exenatide at any time on the dosing day, with or without meals.38 70 The day of once-weekly administration (once every 7 days) can be changed if necessary, provided the last dose was administered 3 or more days previously.38
Importance of informing patients to discontinue exenatide once extended-release exenatide is initiated.38 Importance of informing patients that transient elevations in blood glucose concentrations may occur but generally improve within the first 2 weeks after initiation of extended-release exenatide therapy.38
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 22 38 70 Importance of informing women about enrolling in the pregnancy registry for exenatide or extended-release exenatide if they use the drugs at any time during pregnancy.1 22 38 70
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., hypertension, history of liver disease, gastroparesis or serious digestive problems, severe kidney disease or kidney transplant).1 21 22 38 70
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Injection, for subcutaneous use
Byetta (available as prefilled cartridge pen)
For injection, extended-release, for subcutaneous use
Bydureon (available as single-dose, prefilled, dual-chambered injection pen with diluent and as single-dose vial with vial connector and prefilled syringe containing diluent)
AHFS DI Essentials. © Copyright 2017, Selected Revisions December 8, 2015. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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