Generic Name and Formulations:
Exenatide 250mcg/mL; soln for SC inj; contains m-cresol and mannitol.
Indications for BYETTA:
Adjunct to diet and excercise to improve glycemic control in adults with type 2 diabetes.
Limitations Of use:
Not a substitute for insulin. Not for treating type 1 diabetes or ketoacidosis. Not studied in combination with prandial insulin or with a history of pancreatitis.
Give by SC inj into thigh, abdomen, or upper arm within 60 mins 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.
History of pancreatitis; consider other antidiabetic therapies. Monitor for pancreatitis; if suspected, promptly discontinue; if confirmed, do not restart. Do not reuse or share pens or needles between patients. Severe GI disorders, renal impairment (CrCl <30mL/min), end-stage renal disease: not recommended. Renal transplantation. Pregnancy (Cat.C). Nursing mothers.
Glucagon-like peptide-1 (GLP-1) receptor agonist.
Concurrent prandial insulin: not recommended. Increased risk of hypoglycemia with concomitant sulfonylurea, insulin, or other insulin secretagogues (eg, meglitinides); consider reducing dose of these. May delay absorption of oral drugs (take these 1hr before exenatide). Monitor warfarin.
GI upset, hypoglycemia, feeling jittery, dizziness, headache, dyspepsia, constipation, asthenia, reduced appetite, GERD, hyperhidrosis; antibody formation (glycemic response may be attenuated), pancreatitis (may be fatal), hypersensitivity reactions.
Prefilled pen (needles not included): 5mcg/dose—1 (60 doses); 10mcg/dose—1 (60 doses)