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Welcome Healthcare Professionals

Byetta Emblem

BYETTA (exenatide) injection is the first FDA-approved incretin mimetic for the treatment of patients with type 2 diabetes. 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.

BYETTA gives your patients a chance at success by lowering A1C with weight loss*

A treatment strategy that aims for A1C management along with modest weight loss is recommended by guidelines of:

  • American Diabetes Association (ADA)4
  • American Association of Clinical Endocrinologists (AACE)5
  • American Heart Association (AHA)6

When it's time to do something different for your patients with type 2 diabetes who are not at goal...

It's time for BYETTA

Learn more about BYETTA, including efficacy and safety information.

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

†SDI data, March 2009.

Indication

BYETTA 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 is not a substitute for insulin. BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
  • The concurrent use of BYETTA with insulin has not been studied and cannot be recommended.
  • BYETTA has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Important Safety Information for BYETTA® (exenatide) injection

Contraindications

  • BYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.

Warnings and Precautions

  • Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, BYETTA should be discontinued promptly. BYETTA should not be restarted if pancreatitis is confirmed.
  • The risk of hypoglycemia is increased when BYETTA is used in combination with a sulfonylurea. Clinicians may consider reducing the sulfonylurea dose.
  • There have been postmarketing reports of renal impairment sometimes requiring hemodialysis and kidney transplantation. BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with renal transplantation. Caution should be applied when initiating BYETTA or escalating the dose of BYETTA in patients with moderate renal failure.
  • Use of BYETTA is not recommended in patients with severe gastrointestinal disease (e.g., gastroparesis).
  • There have been postmarketing reports of hypersensitivity reactions (e.g., anaphylaxis and angioedema). If hypersensitivity reaction occurs, the patient should discontinue BYETTA and other suspect medications and promptly seek medical advice.

Adverse Reactions

  • The most common (≥5%) adverse reactions occurring more frequently than placebo in clinical trials were nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, and dyspepsia. Nausea usually decreases over time.

Drug Interactions

  • There have been postmarketing reports of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin and BYETTA. Monitor INR frequently until stable upon initiation or alteration of BYETTA therapy.

Use in Specific Populations

  • Based on animal data, BYETTA may cause fetal harm. BYETTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Caution should be exercised when BYETTA is administered to a nursing woman.

For complete safety profile and other important prescribing considerations, see the Prescribing Information and Medication Guide.

References

  1. American Diabetes Association. Economic costs of diabetes in the U.S. in 2007. Diabetes Care. 2008;31(3):596-615.
  2. Resnick HE, Foster GL, Bardsley J, et al. Achievement of American Diabetes Association clinical practice recommendations among U.S. adults with diabetes, 1999-2002: the National Health and Nutrition Examination Survey. Diabetes Care. 2006;29(3):531-537.
  3. Bays HE, Chapman RH, Grandy S; for the SHIELD Investigators' Group. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61(5):737-747.
  4. American Diabetes Association. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007; (30 suppl 1):S48-S65.
  5. Jellinger PS, Davidson JA, Blonde L, et al; for the ACE/AACE Diabetes Road Map Task Force. Road maps to achieve glycemic control in type 2 diabetes mellitus: ACE/AACE Diabetes Road Map Task Force. Endocr Pract. 2007;13(3):261-268.
  6. Buse JB, Ginsberg HN, Bakris GL, et al. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Diabetes Care. 2007;30(1):162-172.

Welcome Healthcare Professionals

Byetta Emblem

BYETTA (exenatide) injection is the first FDA-approved incretin mimetic for the treatment of patients with type 2 diabetes. 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.

BYETTA gives your patients a chance at success by lowering A1C with weight loss*

A treatment strategy that aims for A1C management along with modest weight loss is recommended by guidelines of:

  • American Diabetes Association (ADA)5
  • American Association of Clinical Endocrinologists (AACE)6
  • American Heart Association (AHA)7

When it's time to do something different for your patients with type 2 diabetes who are not at goal...

It's time for BYETTA

Learn more about BYETTA, including efficacy and safety information.

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

†SDI data, March 2009.

Indication

BYETTA 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 is not a substitute for insulin. BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
  • The concurrent use of BYETTA with insulin has not been studied and cannot be recommended.
  • BYETTA has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Important Safety Information for BYETTA® (exenatide) injection

Contraindications

  • BYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.

Warnings and Precautions

  • Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, BYETTA should be discontinued promptly. BYETTA should not be restarted if pancreatitis is confirmed.
  • The risk of hypoglycemia is increased when BYETTA is used in combination with a sulfonylurea. Clinicians may consider reducing the sulfonylurea dose.
  • There have been postmarketing reports of renal impairment sometimes requiring hemodialysis and kidney transplantation. BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with renal transplantation. Caution should be applied when initiating BYETTA or escalating the dose of BYETTA in patients with moderate renal failure.
  • Use of BYETTA is not recommended in patients with severe gastrointestinal disease (e.g., gastroparesis).
  • There have been postmarketing reports of hypersensitivity reactions (e.g., anaphylaxis and angioedema). If hypersensitivity reaction occurs, the patient should discontinue BYETTA and other suspect medications and promptly seek medical advice.

Adverse Reactions

  • The most common (≥5%) adverse reactions occurring more frequently than placebo in clinical trials were nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, and dyspepsia. Nausea usually decreases over time.

Drug Interactions

  • There have been postmarketing reports of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin and BYETTA. Monitor INR frequently until stable upon initiation or alteration of BYETTA therapy.

Use in Specific Populations

  • Based on animal data, BYETTA may cause fetal harm. BYETTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Caution should be exercised when BYETTA is administered to a nursing woman.

For complete safety profile and other important prescribing considerations, see the Prescribing Information and Medication Guide.

References

  1. American Diabetes Association. Economic costs of diabetes in the U.S. in 2007. Diabetes Care. 2008;31(3):596-615.
  2. Resnick HE, Foster GL, Bardsley J, et al. Achievement of American Diabetes Association clinical practice recommendations among U.S. adults with diabetes, 1999-2002: the National Health and Nutrition Examination Survey. Diabetes Care. 2006;29(3):531-537.
  3. Bays HE, Chapman RH, Grandy S; for the SHIELD Investigators' Group. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61(5):737-747.
  4. 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.
  5. American Diabetes Association. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007; (30 suppl 1):S48-S65.
  6. Jellinger PS, Davidson JA, Blonde L, et al; for the ACE/AACE Diabetes Road Map Task Force. Road maps to achieve glycemic control in type 2 diabetes mellitus: ACE/AACE Diabetes Road Map Task Force. Endocr Pract. 2007;13(3):261-268.
  7. Buse JB, Ginsberg HN, Bakris GL, et al. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Diabetes Care. 2007;30(1):162-172.

Welcome Healthcare Professionals

Byetta Emblem

BYETTA (exenatide) injection is the first FDA-approved incretin mimetic for the treatment of patients with type 2 diabetes. 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.

BYETTA gives your patients a chance at success by lowering A1C with weight loss*

A treatment strategy that aims for A1C management along with modest weight loss is recommended by guidelines of:

  • American Diabetes Association (ADA)6
  • American Association of Clinical Endocrinologists (AACE)7
  • American Heart Association (AHA)8

When it's time to do something different for your patients with type 2 diabetes who are not at goal...

It's time for BYETTA

Learn more about BYETTA, including efficacy and safety information.

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

†SDI data, March 2009.

Indication

BYETTA 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 is not a substitute for insulin. BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
  • The concurrent use of BYETTA with insulin has not been studied and cannot be recommended.
  • BYETTA has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Important Safety Information for BYETTA® (exenatide) injection

Contraindications

  • BYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.

Warnings and Precautions

  • Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, BYETTA should be discontinued promptly. BYETTA should not be restarted if pancreatitis is confirmed.
  • The risk of hypoglycemia is increased when BYETTA is used in combination with a sulfonylurea. Clinicians may consider reducing the sulfonylurea dose.
  • There have been postmarketing reports of renal impairment sometimes requiring hemodialysis and kidney transplantation. BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with renal transplantation. Caution should be applied when initiating BYETTA or escalating the dose of BYETTA in patients with moderate renal failure.
  • Use of BYETTA is not recommended in patients with severe gastrointestinal disease (e.g., gastroparesis).
  • There have been postmarketing reports of hypersensitivity reactions (e.g., anaphylaxis and angioedema). If hypersensitivity reaction occurs, the patient should discontinue BYETTA and other suspect medications and promptly seek medical advice.

Adverse Reactions

  • The most common (≥5%) adverse reactions occurring more frequently than placebo in clinical trials were nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, and dyspepsia. Nausea usually decreases over time.

Drug Interactions

  • There have been postmarketing reports of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin and BYETTA. Monitor INR frequently until stable upon initiation or alteration of BYETTA therapy.

Use in Specific Populations

  • Based on animal data, BYETTA may cause fetal harm. BYETTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Caution should be exercised when BYETTA is administered to a nursing woman.

For complete safety profile and other important prescribing considerations, see the Prescribing Information and Medication Guide.

References

  1. American Diabetes Association. Economic costs of diabetes in the U.S. in 2007. Diabetes Care. 2008;31(3):596-615.
  2. Resnick HE, Foster GL, Bardsley J, et al. Achievement of American Diabetes Association clinical practice recommendations among U.S. adults with diabetes, 1999-2002: the National Health and Nutrition Examination Survey. Diabetes Care. 2006;29(3):531-537.
  3. Bays HE, Chapman RH, Grandy S; for the SHIELD Investigators' Group. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61(5):737-747.
  4. 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.
  5. 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.
  6. American Diabetes Association. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007; (30 suppl 1):S48-S65.
  7. Jellinger PS, Davidson JA, Blonde L, et al; for the ACE/AACE Diabetes Road Map Task Force. Road maps to achieve glycemic control in type 2 diabetes mellitus: ACE/AACE Diabetes Road Map Task Force. Endocr Pract. 2007;13(3):261-268.
  8. Buse JB, Ginsberg HN, Bakris GL, et al. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Diabetes Care. 2007;30(1):162-172.
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Byetta

BYETTA is now approved for use as monotherapy

Information about the monotherapy indication will appear on this website in the near future. For more information, click the links below:

Indication
BYETTA 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 is not a substitute for insulin. BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
  • The concurrent use of BYETTA with insulin has not been studied and cannot be recommended.
  • BYETTA has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Important Safety Information for BYETTA® (exenatide) injection

Contraindications

  • BYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.

Warnings and Precautions

  • Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, BYETTA should be discontinued promptly. BYETTA should not be restarted if pancreatitis is confirmed.
  • The risk of hypoglycemia is increased when BYETTA is used in combination with a sulfonylurea. Clinicians may consider reducing the sulfonylurea dose.
  • There have been postmarketing reports of renal impairment sometimes requiring hemodialysis and kidney transplantation. BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with renal transplantation. Caution should be applied when initiating BYETTA or escalating the dose of BYETTA in patients with moderate renal failure.
  • Use of BYETTA is not recommended in patients with severe gastrointestinal disease (e.g., gastroparesis).
  • There have been postmarketing reports of hypersensitivity reactions (e.g., anaphylaxis and angioedema). If hypersensitivity reaction occurs, the patient should discontinue BYETTA and other suspect medications and promptly seek medical advice.

Adverse Reactions:

  • The most common (≥5%) adverse reactions occurring more frequently than placebo in clinical trials were nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, and dyspepsia. Nausea usually decreases over time.

Drug Interactions

  • There have been postmarketing reports of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin and BYETTA. Monitor INR frequently until stable upon initiation or alteration of BYETTA therapy.

Use in Specific Populations

  • Based on animal data, BYETTA may cause fetal harm. BYETTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Caution should be exercised when BYETTA is administered to a nursing woman.

For complete safety profile and other important prescribing considerations, see the Prescribing Information and Medication Guide.