Exenatide

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Exenatide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Exenatide injection is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 , 14 ) Limitations of Use Co-administration with other exenatide-containing products is not recommended. ( 1 ) Limitations of Use Exenatide injection contains exenatide. Co-administration with other exenatide-containing products is not recommended. Dosage and administration 2 DOSAGE AND ADMINISTRATION Inject subcutaneously within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). ( 2.1 ) Initiate at 5 mcg per dose twice daily; increase to 10 mcg twice daily after 1 month based on clinical response. ( 2.1 ) 2.1 Recommended Dosing Initiate exenatide injection at 5 mcg administered subcutaneously twice daily at any time within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). Do not administer after a meal. Based on clinical response, the dose of exenatide injection can be increased to 10 mcg twice daily which is recommended after 1 month of therapy, in order to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ] . Administer as a subcutaneous injection in the thigh, abdomen, or upper arm. Rotate injections sites with each dose. Do not use the same site for each injection. Inspect visually for particulate matter and discoloration. Only use exenatide injection if the solution appears clear, colorless and contains no particles. When using exenatide injection with insulin, administer as separate injections and never mix. It is acceptable to inject exenatide injection and insulin in the same body region, but the injections should not be adjacent to each other. If a dose is missed, resume the treatment regimen as prescribed with the next scheduled dose. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including exenatide. Discontinue if pancreatitis is suspected. ( 5.1 ) Never share an exenatide injection pen between patients, even if the needle is changed. ( 5.2 ) Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin : Patients taking an insulin secretagogue or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Reduction in the dose of insulin secretagogues or insulin may be necessary. ( 5.3 ) Acute Kidney Injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.4 ) Severe Gastrointestinal Adverse Reactions : Use has been associated with gastrointestinal adverse reactions, sometimes severe. Exenatide is not recommended in patients with severe gastroparesis. ( 5.5 ) Immunogenicity : Patients may develop antibodies to exenatide. If there is worsening glycemic control or failure to achieve target glycemic control, consider alternative antidiabetic therapy. ( 5.6 ) Hypersensitivity : Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue exenatide and promptly seek medical advice. ( 5.7 ) Drug-induced Immune-mediated Thrombocytopenia : Serious bleeding which may be fatal has been reported. Discontinue exenatide promptly and avoid re-exposure to exenatide. ( 5.8 ) Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. ( 5.9 ) Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.10 ) 5.1 Acute Pancreatitis Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with glucagon-like peptide-1 (GLP-1) receptor agonists, including exenatide [see Adverse Reactions (6.2) ]. After initiation of exenatide, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue exenatide and initiate appropriate management. 5.2 Never Share an Exenatide Injection Pen Between Patients Exenatide injection pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens. 5.3 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin Patients receiving exenatide in combination with an insulin