Bydureon BCise Disease Interactions

Exenatide should not be used in patients with severe renal impairment (CrCl <30 mL/min) or end-stage renal disease, and should be used with caution in patients with moderate renal impairment and renal transplantation.

The use of GLP-1 receptor agonists has been associated with rare reports of acute pancreatitis. Other antidiabetic therapies should be considered in patients with a previous history of pancreatitis, although it is not known if they are at increased risk. Patients receiving treatment with GLP-1 receptor agonists should be observed carefully for signs and symptoms of pancreatitis. If this diagnosis is suspected, the treatment should be discontinued immediately and appropriate management should be initiated. Treatment with GLP-1 receptor agonists should be permanently discontinued if pancreatitis is confirmed.

GLP-1 receptor agonist antidiabetic drugs are contraindicated in patients with a personal or family history of medullary thyroid carcinoma and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Carcinogenicity studies in rodents and limited postmarketing data suggest that GLP-1 inhibitors may cause a dose-related and treatment duration-related increase in risk of thyroid C-cell tumors, although a causal relationship has not been established.

There have been reports of acute renal failure and worsening of chronic renal failure sometimes requiring hemodialysis in patients treated with GLP-1 receptor inhibitors. Some of these events occurred in patients without known underlying renal disease. These drugs should be used with caution in patients with renal impairment, especially during treatment initiation or dose escalation. Patients should be monitored, especially if they report severe gastrointestinal reactions such as nausea, vomiting, diarrhea, or dehydration. The frequency of gastrointestinal events is increased as renal function declines. There is limited clinical experience with most of these drugs in patients with severe renal impairment.