• Type 2 diabetes mellitus (as adjunct to diet and exercise).

Contraindicated in:

• Hypersensitivity
• History of drug-induced immune-mediated thrombocytopenia from exenatide
• Type 1 diabetes or diabetic ketoacidosis
• Severe renal impairment or end-stage renal disease (CCr <30 mL/min) (immediate-release only)
• CCr <45 mL/min (extended-release)
• Severe GI disease
• Personal or family history of medullary thyroid carcinoma (extended-release only)
• Multiple Endocrine Neoplasia syndrome type 2 (extended-release only).

Use Cautiously in:

• History of pancreatitis
• Concurrent use of ACE inhibitors, NSAIDs, or diuretics (↑ risk of renal impairment)
• OB: Use during pregnancy only if maternal benefit outweighs potential fetal risk
• Lactation: Use during breastfeeding only if potential maternal benefit outweighs potential risk to infant
• Pedi: Safety and effectiveness not established in children <18 yr (Byetta) or <10 yr (Bydureon BCise).

Derm: ↑ sweating.

Endo: hypoglycemia, THYROID C-CELL TUMORS (EXTENDED-RELEASE).

GI: diarrhea, nausea, vomiting, ↓ appetite, ↓ weight, cholecystitis, cholelithiasis, dyspepsia, gastrointestinal reflux, PANCREATITIS.

GU: acute renal failure, renal impairment.

Hemat: THROMBOCYTOPENIA.

Local: injection site reactions.

Neuro: dizziness, headache, jitteriness, weakness.

Misc: injection site reactions.

Drug-Drug:

• Concurrent use with sulfonylureas or insulin may ↑ risk of hypoglycemia (↓ dose of sulfonylurea or insulin if hypoglycemia occurs).
• Concurrent use with nateglinide or repaglinide may ↑ risk of hypoglycemia.
• Due to slowed gastric emptying, may ↓ absorption of orally administered medications, especially those requiring rapid GI absorption or require a specific level for efficacy; take oral anti-infectives and oral contraceptives at least 1 hr before injecting exenatide).
• Concurrent use of ACE inhibitors, NSAIDs, or diuretics may ↑ risk of renal impairment.

• Solution for injection (Byetta) (prefilled pens): 300 mcg/1.2 mL (delivers 5 mcg/dose); 600 mcg/2.4 mL (delivers 10 mcg/dose);
• Suspension for injection (Bydureon BCise) (prefilled autoinjectors): 2 mg/0.85 mL;

Immediate Release (Byetta)

• SC (Adults): 5 mcg within 60 min before morning and evening meal; after 1 mo, dose may be ↑ to 10 mcg depending on response.

Extended Release (Bydureon BCise)

• SC (Adults and Children ≥10 yr): 2 mg every 7 days.

Bydureon BCise, Byetta

• Mimics the action of incretin, which promotes endogenous insulin secretion and promotes other mechanisms of glucose lowering.

• Improved control of blood glucose.

Therapeutic Classification: antidiabetics

Pharmacologic Classification:

Absorption: Well absorbed following SUBQ administration.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Excreted mostly by glomerular filtration followed by degradation.

Half-life: Immediate-release: 2.4 hr.

(effects on postprandial blood glucose)

• Instruct patient to take exenatide immediate release as directed within 60 min before a meal. Do not take after a meal. If a dose is missed, skip the dose and take the next dose at the prescribed time. Do not take an extra dose or increase the amount of the next dose to make up for missed dose. If a dose of exenatide extended release is missed, administer as soon as remembered as long as the next dose is due at least 3 days later; if 1 or 2 days later skip dose and administer next dose as scheduled. The day of weekly administration can be changed as long as the last dose was administered 3 or more days before. Advise patient to read Medication Guide before starting therapy and with each Rx refill.
• Instruct patient in proper technique for administration, timing of dose, and concurrent oral medications, storage of medication, and disposal of used needles. Patients should read the Information for Patient insert prior to initiation of therapy and with each Rx refill. Advise patient that New Pen Setup should be done only with each new pen, not with each dose.
• Inform patient that pen needles are not included with pen and must be purchased separately. Advise patient which needle length and gauge should be used. Caution patient not to share pen and needles.
• Caution patient to never share pen with others, even if needle is changed. May cause transmission of bloodborne pathogens.
• Explain to patient that exenatide helps control hyperglycemia but does not cure diabetes. Therapy is usually long term.
• Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hyperglycemic or hypoglycemic episodes.
• Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water, and notify health care professional. Risk of hypoglycemia is increased if sulfonylureas are taken concurrently with exenatide.
• Advise patient to notify health care professional immediately if symptoms of pancreatitis (unexplained, persistent, severe abdominal pain that may or may not be accompanied by vomiting) occur.
• Inform patient that therapy may result in reduction of appetite, food intake, and/or body weight. Dose modification is not necessary. Nausea is more common at initiation of therapy and usually decreases over time.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products. Exenatide delays stomach emptying. Some medications (such as anti-infectives and oral contraceptives) may need to be taken 1 hr before exenatide injection.
• Instruct patient in proper testing of blood glucose and urine ketones. Monitor closely during periods of stress or illness; notify health care professional if significant changes occur.
• Advise patient to inform health care professional of medication regimen before treatment or surgery.
• Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
• Rep: Insulin is the recommended method of controlling blood sugar during pregnancy. Advise patient to notify health care professional if pregnancy is suspected or planned, or if breastfeeding.
• Emphasize the importance of routine follow-up exams and regular testing of blood glucose and HbA1c.

ex-EN-a-tide

NDC Code^*

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-6512- Byetta
    • 0310-6512-01- 1 CARTRIDGE in 1 CARTON (0310-6512-01) > 1.2 mL in 1 CARTRIDGE

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-6520- BYDUREON
    • 0310-6520-04- 4 TRAY in 1 CARTON (0310-6520-04) > 1 KIT in 1 TRAY *.65 mL in 1 SYRINGE *.65 mL in 1 VIAL

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-6524- Byetta
    • 0310-6524-01- 1 CARTRIDGE in 1 CARTON (0310-6524-01) > 2.4 mL in 1 CARTRIDGE

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-6530- BYDUREON
    • 0310-6530-01- 1 CARTRIDGE in 1 TRAY (0310-6530-01) >.65 mL in 1 CARTRIDGE

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-6530- BYDUREON
    • 0310-6530-04- 1 TRAY in 1 CARTON (0310-6530-04) > 4 CARTRIDGE in 1 TRAY >.65 mL in 1 CARTRIDGE

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-6530- BYDUREON
    • 0310-6530-85- 1 TRAY in 1 CARTON (0310-6530-85) > 1 CARTRIDGE in 1 TRAY >.65 mL in 1 CARTRIDGE

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-6540- BYDUREON BCise
    • 0310-6540-04- 4 CARTRIDGE in 1 CARTON (0310-6540-04) >.85 mL in 1 CARTRIDGE (0310-6540-01)

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-6540- BYDUREON BCise
    • 0310-6540-85- 1 CARTRIDGE in 1 CARTON (0310-6540-85) >.85 mL in 1 CARTRIDGE