exenatide (Bydureon)

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

What is exenatide (Bydureon)?

This medication guide provides information about the Bydureon brand of exenatide. Byetta is another brand of exenatide that is not covered in this medication guide.

Exenatide is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently. Bydureon is a long-acting form of exenatide.

Bydureon is used together with diet and exercise to improve blood sugar control in people with type 2 diabetes mellitus. Bydureon is for use in adults and children at least 10 years old.

Bydureon is not for treating type 1 diabetes.

Bydureon may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using Bydureon?

• multiple endocrine neoplasia type 2 (tumors in your glands);
• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or
• a history of low levels of platelets (blood cells that help your blood to clot) while using exenatide.

Tell your doctor if you have ever had:

• kidney disease, or a kidney transplant;
• a stomach disorder that causes slow digestion;
• pancreatitis; or
• gallbladder disease.

Bydureon has caused thyroid tumors in animal studies. It is not known if this could occur in humans. Ask your doctor about the risk.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

How should I use Bydureon?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Bydureon is injected under the skin.

Ask your doctor or pharmacist if you don't understand how to use an injection. Do not allow a young child to use Bydureon without help from an adult.

Prepare your injection only when you are ready to give it. You must give the injection right away after mixing.

Bydureon is usually injected once every 7 days. You may give the injection with or without food at any time of the day. Follow your doctor's instructions. If you change your weekly dosing day, choose a day that is at least 3 days past your last dose.

Your healthcare provider will show you where to inject Bydureon. Do not inject into the same place two times in a row.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Never share an injection pen or syringe even if you changed the needle. Sharing these devices can pass infections from person to person.

Bydureon can lower your platelet counts for up to 10 weeks after you stop using this medicine. You may need frequent medical tests while using this medicine and for a short time after you stop.

Your treatment may also include diet, exercise, weight control, and special medical care.

Do not freeze Bydureon, and throw away the medicine if it has been frozen.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 3 days. Do not use two doses at one time.

What happens if I overdose?

Overdose can cause severe nausea and vomiting, or signs of low blood sugar (headache, hunger, irritability, dizziness, feeling shaky).

What should I avoid while taking Bydureon?

What are the possible side effects of Bydureon?

• severe ongoing nausea and vomiting;
• pain, warmth, swelling, an open wound or scab, or other skin changes where the injection was given;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• signs of a thyroid tumor --swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath;
• pancreas or gallbladder problems --pain in your upper stomach spreading to your back, nausea and vomiting, fever, fast heart rate, yellowing of your skin or eyes;
• low blood sugar --headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
• kidney problems --swelling, urinating less, feeling tired or short of breath.

Common side effects may include:

• indigestion, nausea, vomiting, diarrhea, constipation;
• headache; or
• itching or a small bump where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Bydureon?

Tell your doctor if you use insulin.

Bydureon can make it harder for your body to absorb other medicines you take by mouth. Tell your doctor about all your other medicines, especially:

• oral diabetes medicine;
• blood pressure medicine;
• warfarin (Coumadin, Jantoven);
• diuretic or "water pill"; or
• a pain medicine.

This list is not complete. Other drugs may affect Bydureon, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about exenatide (Bydureon).