Byetta 5 mcg

Exenatide 5 mg.

Warnings
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
Contraindications
Hypersensitivity
ESRD, severe renal impairment (CrCl <30 mL/min)
Family or current history of medullary thyroid carcinoma

Cautions
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

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Byetta 5 mcg only for the indication prescribed.

Verified References
  • FDA Feb 11, 2018
  • CDC Feb 11, 2018
  • Mayo Clinic Feb 11, 2018
  • Drugs.com accessed Feb 11, 2018
  • Medscape accessed Feb 11, 2018
  • Epocrates accessed Feb 11, 2018
  • Webmd accessed Feb 11, 2018