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Byetta Generic Name & Formulations
Legal Class
Rx
General Description
Exenatide 250mcg/mL; soln for SC inj; contains m-cresol and mannitol.
Pharmacological Class
Glucagon-like peptide-1 (GLP-1) receptor agonist.
How Supplied
Prefilled pen (1.2mL, 2.4mL)—1 (60 doses)
Manufacturer
Generic Availability
NO
Byetta Indications
Indications
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Limitations of Use
Not for treating type 1 diabetes. Not studied in patients with a history of pancreatitis. Should not be used with other exenatide-containing products.
Byetta Dosage and Administration
Adult
Give by SC inj into thigh, abdomen, or upper arm within 60mins before AM and PM meals (or before the 2 main meals of the day, approx. ≥6hrs apart). Initially 5mcg twice daily; may increase to 10mcg twice daily after 1 month. Moderate renal impairment (CrCl 30–50mL/min): caution when initiating or escalating doses from 5mcg to 10mcg.
Children
Not established.
Byetta Contraindications
Contraindications
History of drug-induced immune-mediated thrombocytopenia from exenatide products.
Byetta Boxed Warnings
Not Applicable
Byetta Warnings/Precautions
Warnings/Precautions
Do not reuse or share pens between patients, even if the needle is changed. History of pancreatitis; consider other antidiabetic therapies. Monitor for pancreatitis, drug-induced thrombocytopenia; discontinue if suspected; do not restart if confirmed. Acute gallbladder disease (eg, cholelithiasis, cholecystitis). Perform gallbladder studies and clinical follow-up if cholelithiasis is suspected. History of anaphylaxis or angioedema with another GLP-1 agonist; monitor closely. Severe GI disorders, renal impairment (CrCl <30mL/min), ESRD: not recommended. Renal transplantation. Elderly. Pregnancy. Nursing mothers.
Byetta Pharmacokinetics
See Literature
Byetta Interactions
Interactions
Increased risk of hypoglycemia with concomitant sulfonylurea, insulin, or other insulin secretagogues; may need lower dose of these. May delay absorption of oral drugs (take these ≥1hr before exenatide). Monitor warfarin.
Byetta Adverse Reactions
Adverse Reactions
GI upset, hypoglycemia, feeling jittery, dizziness, headache, dyspepsia, constipation, asthenia; antibody formation (glycemic response may be attenuated), pancreatitis (may be fatal), hypersensitivity reactions (discontinue if occur), acute renal injury.
Byetta Clinical Trials
See Literature
Byetta Note
Not Applicable
Byetta Patient Counseling
See Literature
