About Amylin and Lilly

Sharing a commitment to people with diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company created an alliance in 2002 to collaborate on the development and commercialization of unique therapeutic solutions that improve the lives of people with type 2 diabetes.

Amylin Pharmaceuticals, Inc. — Founded in 1987

Committed to improving the lives of people with diabetes
Engaged in the discovery, development, and commercialization of innovative therapies for the treatment of metabolic diseases

Eli Lilly and Company — Founded in 1876

Since 1923, dedicated to providing innovation and technology that lead to improved quality of life for people with diabetes
Recognized as an industry-leading advocate for diabetes awareness, education, and treatment

Amylin: http://www.amylin.com/about/contact-us.php
Lilly: http://www.lilly.com/contact/

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.

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.

Important Safety Information

Precautions:

BYETTA is not a substitute for insulin in insulin-requiring patients. BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Patients should be observed for signs and symptoms of acute pancreatitis (persistent severe abdominal pain which may be accompanied by vomiting). If pancreatitis is suspected, BYETTA and other potentially suspect drugs should be discontinued. Resuming treatment with BYETTA is not recommended if pancreatitis is confirmed and an alternative etiology for the pancreatitis has not been identified.
Patients should be observed for signs and symptoms of hypersensitivity reactions.
BYETTA is not recommended for use in patients with end-stage renal disease, severe renal impairment, or severe gastrointestinal disease.
Patients should be observed for signs of altered renal function, including those who are taking concomitant agents known to affect renal function/hydration status, such as diuretics, ACE inhibitors and NSAIDs, or those experiencing significant vomiting and/or diarrhea, which may lead to dehydration.
Patients receiving BYETTA with a sulfonylurea have an increased risk of hypoglycemia. To reduce the risk of hypoglycemia, clinicians may consider reducing the sulfonylurea dose.

Drug Interactions:

The effect of BYETTA to slow gastric emptying may reduce the extent and rate of absorption of orally administered drugs, so it should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.
Medications that are dependent on threshold concentrations for efficacy, such as contraceptives and antibiotics, should be taken at least 1 hour before BYETTA injection. If such drugs are to be administered with food, they should be taken with a meal or snack when BYETTA is not administered.

Adverse Reactions:

The most common adverse events associated with BYETTA were nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, and dyspepsia.

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

Prescribing Information

Medication Guide

Important Safety Information

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Privacy Statement

02-07-5499-B ©2009 Amylin Pharmaceuticals, Inc. and Lilly USA, LLC.
The BYETTA mark and BYETTA design mark are registered trademarks of Amylin Pharmaceuticals, Inc.
The BYETTA By Your Side mark and design mark are service marks of Amylin Pharmaceuticals, Inc.
All other trademarks are property of their respective owners.
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