BYDUREON- exenatide   
Amylin Pharmaceuticals, LLC

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Medication Guide

BYDUREON® (by-DUR-ee-on)
(exenatide extended-release
for injectable suspension)

Read this Medication Guide before you start using BYDUREON and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about BYDUREON?

Serious side effects may happen in people who use BYDUREON, including:

1.
Possible thyroid tumors, including cancer. During the drug testing process, the medicine in BYDUREON caused rats to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if BYDUREON will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people.
  • Before you start using BYDUREON, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2. Do not use BYDUREON if you or any of your family members have medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not use BYDUREON.
  • While using BYDUREON, tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
2.
Inflammation of the pancreas (pancreatitis), which may be severe and lead to death.

Before using BYDUREON, tell your healthcare provider if you have had:
  • pancreatitis
  • stones in your gallbladder (gallstones)
  • a history of alcoholism
  • high blood triglyceride levels

These medical conditions can make you more likely to get pancreatitis. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking BYDUREON.

Stop using BYDUREON and 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. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.

What is BYDUREON?

Who should not use BYDUREON?

Do not use BYDUREON if:

Talk to your healthcare provider before using this medicine if you have any of these conditions.

What should I tell my healthcare provider before using BYDUREON?

Before using BYDUREON, tell your healthcare provider if you:

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BYDUREON may affect the way some medicines work and some other medicines may affect the way BYDUREON works.

Especially tell your healthcare provider if you take:

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use BYDUREON?

For detailed instructions, see the Instructions for Use that comes with your BYDUREON.

What are the possible side effects of BYDUREON?

BYDUREON can cause serious side effects, including:

The most common side effects of BYDUREON include:

Nausea is most common when you first start using BYDUREON, but decreases over time in most people as their body gets used to the medicine.

Talk to your healthcare provider about any side effect that bothers you or does not go away.

These are not all the side effects of BYDUREON. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store BYDUREON?

Keep BYDUREON, and all medicines, out of the reach of children.

General information about safe and effective use of BYDUREON

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BYDUREON for a condition for which it was not prescribed. Do not give your BYDUREON to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about BYDUREON. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about BYDUREON that is written for healthcare professionals.

For more information about BYDUREON, go to www.BYDUREON.com or call 1-877-700-7365.

What are the ingredients in BYDUREON?

Contents of the powder:

Active Ingredient: exenatide

Inactive Ingredients: polylactide-co-glycolide and sucrose

Contents of liquid (diluent):

Inactive Ingredients: carboxymethylcellulose sodium, polysorbate 20, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, water for injection. Sodium hydroxide may be added during manufacture of BYDUREON Pen for pH adjustment.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

BYDUREON is a registered trademark and BYETTA is a registered trademark of the AstraZeneca group of companies. All other marks are the marks of their respective owners.

Revised: 05/2014
 
Amylin Pharmaceuticals, LLC