July 29, 2016
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"The US Food and Drug Administration (FDA) has approved a once-daily oral combination of linagliptin and metformin hydrochloride (Jentadueto XR, Boehringer Ingelheim and Eli Lilly & Co) for treating adults with type 2 diabetes.



How Supplied


Type 2 Diabetes Mellitus

BYETTA (exenatide injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Important Limitations of Use

BYETTA (exenatide injection) is not a substitute for insulin. BYETTA (exenatide injection) should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

The concurrent use of BYETTA (exenatide injection) with insulin has not been studied and cannot be recommended.

Based on postmarketing data BYETTA (exenatide injection) has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. BYETTA (exenatide injection) has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA (exenatide injection) . Other antidiabetic therapies should be considered in patients with a history of pancreatitis.


Recommended Dosing

BYETTA (exenatide injection) should be initiated at 5 mcg 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 (exenatide injection) should not be administered after a meal. Based on clinical response, the dose of BYETTA (exenatide injection) can be increased to 10 mcg twice daily after 1 month of therapy. Initiation with 5 mcg reduces the incidence and severity of gastrointestinal side effects. Each dose should be administered as a subcutaneous (SC) injection in the thigh, abdomen, or upper arm. No data are available on the safety or efficacy of intravenous or intramuscular injection of BYETTA (exenatide injection) .

Use BYETTA (exenatide injection) only if it is clear, colorless and contains no particles.


Dosage Forms And Strengths

BYETTA (exenatide injection) is supplied as a sterile solution for subcutaneous injection containing 250 mcg/mL exenatide in the following packages:

  • 5 mcg per dose, 60 doses, 1.2 mL prefilled pen
  • 10 mcg per dose, 60 doses, 2.4 mL prefilled pen

BYETTA (exenatide injection) 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 66780-212-01

Storage and Handling

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

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 (exenatide injection) .com. Literature Revised September 2010.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/20/2012

How Supplied

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