BYETTA is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control.

BYETTA therapy should be initiated at 5 mcg per dose administered 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). BYETTA should not be administered after a meal. Based on clinical response, the dose of BYETTA can be increased to 10 mcg twice daily after 1 month of therapy. Each dose should be administered as a SC injection in the thigh, abdomen, or upper arm.

BYETTA is recommended for use in patients with type 2 diabetes mellitus who are already receiving metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, and have suboptimal glycemic control. When BYETTA is added to metformin or thiazolidinedione therapy, the current dose of metformin or thiazolidinedione can be continued as it is unlikely that the dose of metformin or thiazolidinedione will require adjustment due to hypoglycemia when used with BYETTA. When BYETTA is added to sulfonylurea therapy, a reduction in the dose of sulfonylurea may be considered to reduce the risk of hypoglycemia (see PRECAUTIONS, Hypoglycemia).

BYETTA is a clear and colorless liquid and should not be used if particles appear or if the solution is cloudy or colored. BYETTA should not be used past the expiration date. No data are available on the safety or efficacy of intravenous or intramuscular injection of BYETTA.

Storage

Prior to first use, BYETTA must be stored refrigerated at 36°F to 46°F (2°C to 8°C). After first use, BYETTA can be kept at a temperature not to exceed 77°F (25°C). Do not freeze. Do not use BYETTA if it has been frozen. BYETTA should be protected from light. The pen should be discarded 30 days after first use, even if some drug remains in the pen.

BYETTA is supplied as a sterile solution for subcutaneous injection containing 250 mcg/mL exenatide. The following packages are available:

5 mcg per dose, 60 doses, 1.2 mL prefilled pen NDC 66780-210-07
10 mcg per dose, 60 doses, 2.4 mL prefilled pen NDC 66780-210-08

Manufactured for Amylin Pharmaceuticals, Inc., San Diego, CA 92121. Marketed by Amylin Pharmaceuticals, Inc. and Eli Lilly and Company. 1-800-868-1190. http://www.BYETTA.com. Literature Revised December 2007. FDA rev date: 1/11/2008

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