Exenatide, a GLP-1 receptor agonist, has been approved as monotherapy for adults with type 2 diabetes, as an adjunct to diet and exercise, the manufacturer announced.
Previously, exenatide--marketed as Byetta by Amylin Pharmaceuticals and Eli Lilly & Co.--was approved for treating type 2 diabetes in combination with other diabetes medications plus diet and exercise.
The FDA also approved changes to the safety information in the label, including the addition of pancreatitis in the warnings and precautions section, which addresses a previous FDA alert. The label advises against the use of exenatide in patients with severe renal impairment or end-stage renal disease and recommends that it be used cautiously in patients who have had a kidney transplant.
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Exenatide is injected subcutaneously within 60 minutes before morning and evening meals, or before the two main meals of the day, about 6 hours or more apart. The recommended starting dose is 5 mcg twice a day, increasing to 10 mcg twice a day after 1 month if needed.
