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Information ⬇

exenatide

ex-en-a-tide

Trade Name(s): (Bydureon BCise, Byetta, 5 mcg Pen, 10 mcg Pen)

■BLACK BOX ALERT ■ (Bydureon): Risk of thyroid C-cell tumors.

Classification ⬆ ⬇

Uses ⬆ ⬇

Adjunct to diet, exercise to improve glycemic control in adults (immediate-release and extended-release) and pediatric patients 10 yrs of age or older (extended-release only) with type 2 diabetes mellitus.

Precautions ⬆ ⬇

Contraindications: Hypersensitivity to exenatide. Bydureon only: History of medullary thyroid carcinoma. Pts with multiple endocrine neoplasia syndrome type 2 (MEN2). History of drug-induced immune-mediated thrombocytopenia. Cautions: Diabetic ketoacidosis, type 1 diabetes mellitus. Pts with renal transplantation or moderate renal impairment. Not recommended in severe renal impairment, severe GI disease, pancreatitis.

Action ⬆ ⬇

Stimulates release of insulin from beta cells of pancreas, mimics enhancement of glucose-dependent insulin secretion, suppresses elevated glucagon secretion, slows gastric emptying (central action increases satiety). Therapeutic Effect: Improves glycemic control by increasing postmeal insulin secretion, decreasing postmeal glucagon levels, delaying gastric emptying, and increasing satiety.

Pharmacokinetics ⬆ ⬇

Minimal systemic metabolism. Eliminated by glomerular filtration with subsequent proteolytic degradation. Half-life: 2.4 hrs.

Lifespan Considerations ⬆ ⬇

Pregnancy/Lactation: Unknown if distributed in breast milk. Children: Safety and efficacy not established. Elderly: No age-related precautions noted.

Interactions ⬆ ⬇

DRUG: May decrease concentration/effect of oral contraceptives. May increase hypoglycemic effect of insulin, sulfonylureas (e.g., glyburide). HERBAL: None significant. FOOD: None known. LAB VALUES: None known.

Availability ⬆ ⬇

Injection, Solution (Prefilled Pen): (Byetta): 10 mcg/0.04 mL (2.4 mL); 5 mcg/0.02 mL (1.2 mL). Injection Prefilled Single-Dose Auto-Injector: (Bydureon BCise): 2 mg in 0.85 ml vehicle.

Administration/Handling ⬆ ⬇

SQ
  • May be given in thigh, abdomen, upper arm.
  • Rotation of injection sites is essential; maintain careful injection site record.
  • Give within 60 min before morning and evening meals. Give suspension immediately after powder is suspended.
  • Storage
  • Refrigerate prefilled pens.
  • Discard if freezing occurs.
  • May be stored at room temperature after first use.
  • Discard pen 30 days after initial use.
  • (Bydureon BCise): Remove from refrigerator 15 min prior to mixing. To mix, shake vigorously for at least 15 sec.
INDICATIONS/ROUTE/DOSAGE
Diabetes Mellitus

SQ: ADULTS, ELDERLY: (Immediate-release): 5 mcg per dose given twice daily within the 60-min period before the morning and evening meals. Dose may be increased to 10 mcg twice daily after 1 mo of therapy. ADULTS, ELDERLY, CHILDREN 10 YRS AND OLDER: (Extended-release): 2 mg once q7days any time of day, with or without meals.

Dosage in Renal Impairment

Mild impairment: No dose adjustment. Moderate impairment: Use caution. Severe impairment: CrCl less than 30 mL/min or ESRD: Not recommended.

Dosage in Hepatic Impairment

No dose adjustment.

Side Effects ⬆ ⬇

(Byetta): Frequent (44%): Nausea. Occasional (13%–6%): Diarrhea, vomiting, dizziness, anxiety, dyspepsia. Rare (less than 6%): Weakness. (Bydureon): 5% or greater: Nausea, diarrhea, headache, constipation, vomiting, dyspepsia, injection site pruritus or nodule.

Adverse Effects/Toxic Reactions ⬆ ⬇

With concurrent sulfonylurea, hypoglycemia occurs in 36% when given a 10-mcg dose of exenatide, 16% when given a 5-mcg dose. May cause acute pancreatitis.

Nursing Considerations ⬆

  • BASELINE ASSESSMENT Check serum glucose before administration. Discuss lifestyle to determine extent of learning, emotional needs. Ensure follow-up instruction if pt or family does not thoroughly understand diabetes management, glucose-testing technique. At least 1 mo should elapse to assess response to drug before new dose adjustment is made. INTERVENTION/EVALUATION Monitor serum glucose, food intake, renal function. Assess for hypoglycemia (cool wet skin, tremors, dizziness, anxiety, headache, tachycardia, numbness in mouth, hunger, diplopia), hyperglycemia (polyuria, polyphagia, polydipsia, nausea, vomiting, dim vision, fatigue, deep rapid breathing). Be alert to conditions that alter glucose requirements (fever, increased activity or stress, surgical procedure). PATIENT/FAMILY TEACHING
  • Diabetes mellitus requires lifelong control.
  • Prescribed diet and exercise are principal parts of treatment. Do not skip, delay meals.
  • Continue to adhere to dietary instructions, regular exercise program, regular testing of serum glucose.
  • When taking combination drug therapy or when glucose conditions are altered (excessive alcohol ingestion, insufficient carbohydrate intake, hormone deficiencies, critical illness), have a low blood sugar treatment available (e.g., glucagon, oral dextrose).
  • Report any unexplained severe abdominal pain with or without nausea or vomiting.