exenatide

ROUTE	ONSET	PEAK	DURATION
SUBQ (immediate-release)	within 30 min	2.1 hr	8 hr
SUBQ (extended-release)	unknown	9 wk	unknown

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).

Adv. Reactions/Side Effects ⬆ ⬇

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

Interactions ⬆ ⬇

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.

Route/Dosage ⬆ ⬇

Immediate Release (Byetta)

Extended Release (Bydureon BCise)

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

Renal Impairment

SC (Adults ): CCr 30–50 mL/min: Use caution when ↑ dose from 5 mcg to 10 mcg.
SC (Adults and Children ≥10 yr): 2 mg every 7 days.

Availability ⬆ ⬇

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

Assessment ⬆ ⬇

Observe for signs and symptoms of hypoglycemic reactions (abdominal pain, sweating, hunger, weakness, dizziness, headache, drowsiness, tremor, tachycardia, anxiety, confusion, irritability, jitteriness), especially when combined with oral sulfonylureas.
Assess for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back, may or may not be accompanied by vomiting) at beginning of therapy and with dose increases. If suspected, promptly discontinue therapy and initiate appropriate management. If pancreatitis is confirmed, do not restart exenatide. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Lab Test Considerations:

Monitor serum glucose and HbA1c periodically during therapy to evaluate effectiveness of therapy.
- Monitor renal function prior to and periodically during therapy. Renal dysfunction may be reversed with discontinuation of therapy.

Implementation ⬆ ⬇

Some medications (anti-infectives, oral contraceptives) may need to be taken 1 hr before exenatide.
- Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
SC: Immediate release: Follow directions for New Pen Setup in Information for Patient prior to use of each new pen. Inject exenatide in thigh, abdomen, or upper arm at any time within the 60-min period before the morning and evening meals. Do not administer after a meal. Do not mix with insulin. Solution should be clear and colorless; do not administer solutions that are discolored or contain particulate matter. Refrigerate; discard pen 30 days after 1st use, even if some drug remains in pen. Do not freeze. Do not store pen with needle attached; medication may leak from pen or air bubbles may form in the cartridge.
SC: Extended release: Remove from refrigerator 15 min prior to mixing. Dilute with diluent and needles included in tray. Suspension should be white or off-white and cloudy. Mix by shaking vigorously for 15 sec. Do not inject solutions that are discolored or contain particulate matter. Administer without regard to meals. Inject into upper arm, abdomen, or thigh; change site each wk. Refrigerate; each tray can be kept at room temperature if not >77°F for up to 4 wk. Store Bydureon BCise flat. Do not use beyond expiration date.
- Do not mix insulin in the same syringe with exenatide. Injection of Bydureon Bcise and insulin may be administered in the same body area, but not right next to each other.
- If switching from immediate-release to extended-release, discontinue other forms of exenatide before starting Bydureon BCise. When switching from another extended-release product, may change with next scheduled dose. May cause transient ↑ in blood glucose for 2–4 wk.

Patient/Family Teaching ⬆ ⬇

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.

Evaluation/Desired Outcomes ⬆ ⬇

Control of blood glucose levels without the appearance of hypoglycemic or hyperglycemic episodes.

US Brand Names ⬆ ⬇

Bydureon BCise, Byetta

Code ⬆

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

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇