Brand and Other Names:Byetta
Dosing & Uses
Dosage Forms & Strengths
injectable solution, prefilled pen
- 250mcg/mL (1.2mL vial)
- 250mcg/mL (2.4mL vial)
Diabetes Mellitus, Type 2
Adjunct to diet and exercise to improve glycemic control with DM type 2; monotherapy or as an adjunct therapy with thiazolidinediones, metformin, or a sulfonylurea; or add-on therapy to insulin glargine (a long-acting insulin), with or without metformin and/or a thiazolidinedione, in patients who are not achieving adequate glycemic control on insulin glargine alone
Immediate-release: 5 mcg SC q12hr within 60 minutes prior to meal intially; after 1 month, may increased to 10 mcg q12hr
Switching from immediate-release to extended-release
- Initiate weekly extended-release SC injections 1 day after discontinuing immediate-release exenatide
- May experience increased blood glucose levels for approximately 2 weeks after initiating extended-release therapy
- May initiate extended-release exenatide without pretreating with the immediate-release dosage form
Within 60 minutes before morning and evening meals, approximately 6 hr or more apart
Administer SC only; do not administer IM or IV
Injection sites are thigh, abdomen, or upper arm
- Mild renal impairment (CrCl 50-80 mL/min): No dosage adjustment required
- Moderate renal impairment (CrCl 30-50 mL/min): Caution when initiating or escalating dose
- Severe renal impairment (CrCl <30 mL/min) or ESRD: Not recommended
- Renal transplantation: Use with caution
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Injection-site nodule (6-77%)
Injection-site reactions (2-18%)
Upper respiratory infection
Black Box Warnings
Risk of thyroid C-cell tumors
- Increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls; unknown whether this risk for medullary thyroid carcinoma (MTC) exists in humans, as human relevance could not be determined by clinical or nonclinical studies
- Contraindicated in patients with a personal or family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
- Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with exenatide injectable suspension
- Patients should be counseled regarding the risk and symptoms of thyroid tumors
ESRD, severe renal impairment (CrCl <30 mL/min)
Family or current history of medullary thyroid carcinoma
Never share a pen between patients even if the needle is changed
Not a substitute for insulin
Not a first-line therapy for patients inadequately controlled on diet and exercise alone
Evaluate insulin dose when added on to long-acting insulin (ie, insulin glargine); in patients with increased risk of hypoglycemia, consider decreasing insulin dose
Not recommended for patients experiencing severe gastrointestinal disease, including gastroparesis
Not recommended for type 1 diabetes
Do not take with short- and/or rapid-acting insulins
Animal studies show association of extended-release dosage form with the formation of thyroid tumors (effects in humans unknown)
Always administer before a meal and never after a meal
Weight loss resulting from reduced intake reported
Risk of acute pancreatitis reported, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis
Increased risk of hypoglycemia in patients taking insulin secretagogues; may require dose reduction of sulfonylureas
Risk of renal failure
Antibody formation to exenatide is likely; up to 4% of patients may have worsening glycemic control and require alternative antidiabetic therapy
Pregnancy & Lactation
Pregnancy category: C
Lactation: Excretion in milk unknown; use with caution
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
A glucagonlike peptide-1 (GLP-1) that mimics incretin and promotes insulin secretion, suppresses glucagon, and slows gastric emptying
Peak plasma time: 2.1 hr
Peak plasma concentration: 211 pg/mL
AUC: 1036 pg·hr/mL
Vd: 28.3 L
Proteolytic degradation following glomerular filtration
Half-life: 2.4 hr (immediate release); 2 weeks (extended release)
Renal clearance: 9.1 L/hr
Excretion: Urine (primarily)
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|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.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Select a box to add or remove a plan.
Select a class to view formulary status for similar drugs