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BYETTA® (EXENATIDE) INJECTION

BYETTA® (exenatide) injection is a first-in-class type 2 diabetes therapy offering powerful, sustained A1C reductions with potential weight loss.

ABOUT BYETTA

BYETTA is the first FDA-approved agent in a class of diabetes therapies called GLP-1 receptor agonist. BYETTA is an injectable medication that exhibits many of the same glucoregulatory actions of GLP-1 (glucagon-like peptide-1), a naturally occurring incretin hormone.

GLP-1 stimulates the body’s ability to produce insulin in response to elevated levels of blood sugar; inhibits the release of a hormone called glucagon following meals; slows the rate at which nutrients are absorbed into the bloodstream; and enhances the feeling of fullness at meals to reduce the appetite.

BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program.

BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.

BYETTA is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials.

Clinical data from three important clinical studies with BYETTA underscore the combination of glucose control with potential weight loss. Highlights include:
  • At 30 weeks in an open-label, active-controlled comparator trial (N = 147), BYETTA delivered powerful A1C reductions of 1.5% with weight loss.1
  • After 3 years in an open-label extension of registration trials (N = 217), most patients using BYETTA sustained glycemic control with weight loss:2
    • 78% had A1C improvement (average 1% reduction from baseline of 8.2%).  
    • 84% had weight loss (average of 11.8 pounds from baseline of 219 pounds).  
  • Up to 4X more patients reached an A1C ≤7% when BYETTA was added compared to patients on oral therapy alone (metformin or a thiazolidinedione ± metformin).3,4 
  • Sustained glucose control and progressive weight loss in patients using BYETTA for three years.
  • A blood glucose lowering effect comparable to insulin glargine—often with weight loss instead of weight gain—and a decrease in hypoglycemia compared with insulin glargine.

Important Safety Information for BYETTA® (exenatide) injection

  • Serious side effects can happen in people who take BYETTA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking BYETTA, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. Call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may happen with or without vomiting and may be felt going from your abdomen through to your back.
  • Your risk for getting low blood sugar is higher if you take BYETTA with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while you use BYETTA.
  • BYETTA should not be used in people who have severe kidney problems and should be used with caution in people who have had a kidney transplant. BYETTA may cause new or worse problems with kidney function, including kidney failure.
  • Before you use BYETTA, tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
  • Do not use BYETTA if you have had an allergic reaction to exenatide or any of the other ingredients in BYETTA. Severe allergic reactions can happen with BYETTA. Stop taking BYETTA and get medical help right away.
  • Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYETTA will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.
  • The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly happens when first starting BYETTA, but may become less over time.

These are not all the side effects with BYETTA. Talk to your healthcare provider about any side effect that bothers you or that does not go away.

Healthcare professionals and people with diabetes may obtain more information, including the complete prescribing information and patient Medication Guide, at www.BYETTA.com.

References

1 Data on file, Amylin Pharmaceuticals, Inc. and Lilly USA, LLC.

2 Klonoff DC, Buse JB, Nielsen LL, et al. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008;24(1):275-286.

3 DeFronzo RA, Ratner RE, Han J, et al. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005;28(5):1092-1100.

4 Zinman B, Hoogwerf BJ, Duran Garcia S, et al. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007;146(7):477-485.