Byetta


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exenatide acetate

Byetta, Bydureon

Pharmacologic class: Incretin mimetic

Therapeutic class: Hypoglycemic

Pregnancy risk category C

Action

Enhances glucose-dependent insulin secretion by the pancreatic beta cells, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying

Availability

Solution for injection: 250 mcg/ml as 60 doses in 5-mcg-per-dose/1.2-ml prefilled pen, 250 mcg/ml as 60 doses in 10-mcg-per-dose/2.4-ml prefilled pen

Suspension for injection (extendedrelease): 2 mg/vial

Indications and dosages

Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus

Adults: 5 mcg (Byetta) injected subcutaneously in thigh, abdomen, or upper arm twice daily within 60 minutes before morning and evening meals. Dosage can be increased to 10 mcg after 1 month of therapy, based on clinical response. Or, 2 mg (Bydureon) injected subcutaneously once q 7 days (weekly) at any time of day, with or without meals.

Dosage adjustment

• Concurrent sulfonylurea use (Byetta)

Contraindications

• Hypersensitivity to drug or its components
• Personal or family history of medullary thyroid carcinoma; multiple endocrine neoplasia syndrome type 2 (Bydureon)

Precautions

Use cautiously in:
• severe renal impairment or end-stage renal disease, history of pancreatitis
• severe GI disease (use not recommended)
• type 1 diabetes or diabetic ketoacidosis (avoid use)
• drugs that have narrow therapeutic index or require rapid GI absorption
• concurrent use of insulin (Bydureon use not recommended); concurrent use of prandial insulin (Byetta use not recommended); or concurrent use of other glucose-independent insulin secretagogues (Byetta)
• elderly patients
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Administer oral drugs 1 hour before exenatide. For oral drugs that must be taken with food, administer these with a light meal or snack when exenatide isn't given.
• Discard pen 30 days after first use, even if some drug remains. Don't freeze, and don't use drug if it has been frozen.
• Be aware that Bydureon is intended for patient self-administration and must be administered immediately after powder is suspended.
• Don't coadminister Bydureon and Byetta

Adverse reactions

CNS: dizziness, headache, asthenia, jitteriness

GI: nausea, vomiting, diarrhea, dyspepsia, gastroesophageal reflux disease, acute pancreatitis

Metabolic: hypoglycemia (especially with concurrent sulfonylurea)

Skin: excessive sweating

Other: decreased appetite, general injection site reaction, hypersensitivity reaction

Interactions

Drug-drug.Anti-infectives, hormonal contraceptives: possible slowing of GI transit time

Drug-behaviors.Alcohol use: reduced blood glucose level

Patient monitoring

• Monitor serum glucose level frequently, especially in patients also receiving sulfonylureas.
• Monitor renal function tests periodically.

Be aware that Bydureon hasn't been studied with warfarin; however, postmarketing reports indicate increased INR, sometimes associated with bleeding, occurs with concomitant use of warfarin and Byetta. Monitor prothrombin time more frequently in patients taking warfarin after starting or altering therapy. Once a stable prothrombin time has been documented, prothrombin times can be monitored at intervals usually recommended for patients on warfarin.

Be aware that exenatide has been associated with acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue drug and initiate appropriate management. If pancreatitis is confirmed, don't restart drug.

Patient teaching

• Instruct patient to take Byetta within 1 hour before morning and evening meals meals (or before the two main meals of the day, approximately 6 hours or more apart).
• Teach patient how to self-administer Byetta with prefilled pen. Tell patient to do a new pen set-up one time only, when starting a new prefilled pen. Advise patient to discard pen 30 days after first use, even if some drug remains.

Instruct patient to inject Bydureon subcutaneously once every 7 days at any time of day, with or without a meal.

Tell patient that Bydureon is provided in a single-dose tray containing one 2-mg vial of drug, one vial connector, one prefilled diluent syringe, and two needles (one provided as a spare). Instruct patient not to substitute needles or any other components in tray. Tell patient to follow manufacturer's directions precisely for preparing the drug for injection and that the drug must be injected immediately after the powder is suspended in the diluent and transferred to the syringe.
• Caution patient not to freeze drug and not to use it if it has been frozen.

Teach patient to recognize and immediately report signs and symptoms of hypoglycemia and diabetic ketoacidosis.

Teach patient how to recognize and to promptly report signs and symptoms of pancreatitis.
• Advise patient to avoid alcohol during therapy.
• Instruct breastfeeding patient to either discontinue breastfeeding or stop taking drug.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.

exenatide

(ex-en-a-tide) ,

Bydureon

(trade name),

Byetta

(trade name)

Classification

Therapeutic: antidiabetics
Pharmacologic: incretin mimetic agents
Pregnancy Category: C

Indications

Management of type 2 diabetes as an adjunct to diet and exercise.

Action

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

Therapeutic effects

Improved control of blood glucose.

Pharmacokinetics

Absorption: Well absorbed following subcutaneous administration.
Distribution: Unknown.
Metabolism and Excretion: Excreted mostly by glomerular filtration followed by degradation.
Half-life: Immediate-release—2.4 hr.

Time/action profile (effects on post-prandial blood glucose)

ROUTEONSETPEAKDURATION
Subcut (immediate-release)within 30 min2.1 hr8 hr
Subcut (extended-release)unknown9 wkunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Type 1 diabetes or diabetic ketoacidosis;Severe renal impairment or end-stage renal disease (CCr <30 mL/min);Severe gastrointestinal disease;Personal or family history of medullary thyroid carcinoma (extended-release only)Multiple Endocrine Neoplasia syndrome (extended-release only) Obstetric: Has caused fetal physical defects and neonatal death in animal studies; Lactation: Excretion into breast milk unknown.
Use Cautiously in: History of pancreatitis;Moderate renal impairment (CCr 30–50 mL/min);Concurrent use of insulin (extended-release only) Pediatric: Safety not established.

Adverse Reactions/Side Effects

Cardiovascular

  • dizziness
  • headache
  • jitteriness
  • weakness

Gastrointestinal

  • pancreatitis (life-threatening)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • vomiting (most frequent)
  • dyspepsia
  • gastroinestinal reflux

Endocrinologic

  • thyroid t-cell tumors (extended-release) (life-threatening)
  • hypoglycemia

Genitourinary

  • acute renal failure

Dermatologic

  • hyperhydrosis

Metabolic

  • ↓ appetite
  • weight loss

Interactions

Drug-Drug interaction

Concurrent use with sulfonylureas or insulin may ↑ risk of hypoglycemia (↓ dose of sulfonylurea or insulin if hypoglycemia occurs); concomitant use of insulin with extended-release exenatide not recommended.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).

Route/Dosage

Immediate Release (Byetta)
Subcutaneous (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

Subcutaneous (Adults) CCr 30–50 mL/min—Use caution when ↑ dose from 5 mcg to 10 mcg.
Extended Release (Bydureon)
Subcutaneous (Adults) 2 mg every 7 days.

Availability

Solution for subcutaneous injection (Byetta): 250 mcg/mL in prefilled pen-injector that delivers either 5 mcg/dose (1.2-mL pen) or 10 mcg/dose (2.4-mL pen) for 60 doses (30 days of twice daily dosing)
Suspension for subcutaneous injection (Bydureon): 2 mg/vial

Nursing implications

Nursing 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 glycolysated hemoglobin 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.

Potential Nursing Diagnoses

Imbalanced nutrition: more than body requirements (Indications)
Noncompliance (Patient/Family Teaching)

Implementation

  • Some medications 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.
  • Subcutaneous: 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.
  • Subcutaneous: Extended release: Dilute with diluent and needles included in tray. Suspension should be white or off-white and cloudy. Administer without regard to meals. Inject into upper arm, abdomen, or thigh; change site each week. Refrigerate; each tray can be kept at room temperature if not >77°F for up to 4 wks. Do not use beyond expiration date.

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.
  • 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.
  • 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 sulfonureas are taken concurrently with exenatide.
  • Advise patient to notify health care professional immediately if symptoms of pancreatitis (unexplained, persistent, severe abdominal pain which 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. These tests should be monitored closely during periods of stress or illness and health care professional notified if significant changes occur.
  • Advise patient to inform health care professional of medication regimen before treatment or surgery.
  • Advise patient to notify health care professional if pregnancy is suspected or planned.
  • Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
  • Emphasize the importance of routine follow-up exams and regular testing of blood glucose and glycosylated hemoglobin.

Evaluation/Desired Outcomes

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

Byetta

exenatide
References in periodicals archive ?
Of the eight donors who were on incretin therapy, seven had been taking sitagliptin, sold in pill form as Januvia and marketed by Merck, and one had been on exenatide, sold as Byetta by Bristol-Myers Squibb.
BYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.
Table 1 shows the comparison of pharmacokinetics properties for Byetta (AC2993) and Victoza (liraglutide/NN2211).
but Lilly's in a revenue bind, and Byetta seems to have maxed out
Byetta has lost shares of new prescriptions at a faster rate than for the total prescriptions, which indicates that more doctors are giving new patients Victoza instead of Byetta," Citigroup analyst Yaron Werber explained.
The FDA announced it has acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide) Injection, a drug used to treat type 2 diabetes.
Liraglutide, a once-daily injectable with a similar mechanism to exenetide, is expected to hit the market in early 2009, and a new once-weekly version of Byetta also is being developed.
Approved in 2006, Byetta is classified as an incretin mimetic because it mimics the effects of the incretin hormone GLP-1 produced within the small intestine.
X New Storage Instructions for Byetta: The Byetta pen-containing multiple doses of the drug to treat type 2 diabetes--no longer needs to be refrigerated after using it for the first time.
Branded agents vying for space in second-line treatment include the DPP-IV inhibitors Januvia (Merck's sitagliptin) and Onglyza (Bristol-Myers Squibb/AstraZeneca's saxagliptin), the PPAR-gamma agonist Actos (Takeda's pioglitazone), the GLP-1 analogues Byetta (Amylin/Eli Lilly's exenatide) and Victoza (Novo Nordisk's liraglutide), and the insulin analogues Lantus (Sanofi-Aventis's insulin glargine) and Levemir (Novo Nordisk's insulin detemir).
The DURATION-5 trial was a randomized open-label clinical study of 252 adult patients with type 2 diabetes and inadequate glycemic control with diet and exercise alone or with oral antidiabetic therapy, including metformin, a sulfonylurea, a thiazolidinedione, or a combination of two of these oral type 2 diabetes medications comparing Bydureon to Byetta.