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
- Table of Contents
- Brief Summary
- Dosing & Uses
- Adverse Effects
- Warnings
- Pregnancy and Breastfeeding Warnings
- Pharmacology
- Administration
- Patient Education
- Post More Contents
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