Exenatide (extended release)

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.

Call your doctor right away if you notice signs of a thyroid tumor, like swelling or a lump in your neck, difficulty swallowing, a hoarse voice, or trouble breathing.

You should not use Bydureon if you are allergic to exenatide, or if you have:

• 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.

Ask a doctor if it is safe to breastfeed while using this medicine.

Not approved for use by anyone younger than 10 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking exenatide have experienced serious or fatal bleeding due to low platelet levels (blood cells that help with clotting). Stop using Bydureon and contact your doctor immediately if you notice unusual bleeding or bruising.

This medicine can cause serious side effects. Stop using it and call your doctor right away if you experience:

• severe ongoing nausea and vomiting;
• pain, warmth, swelling, an open wound or scab, or other skin changes at the injection site;
• 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 issues—pain in your upper stomach that spreads 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 issues—swelling, urinating less, feeling tired or short of breath.

Common side effects of exenatide may include:

• indigestion, nausea, vomiting, diarrhea, constipation;
• headache; or
• itching or a small bump at the injection site.

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

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.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

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.

Store Bydureon in its original container. Refrigerate and use until expiration date. Protect from light.

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

You may also store Bydureon at room temperature for up to 4 weeks.

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 the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Taking too much can lead to severe nausea and vomiting, or symptoms of low blood sugar (headache, hunger, irritability, dizziness, feeling shaky).

You should not mix Bydureon with insulin in the same syringe. Do not use Bydureon along with Byetta.

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.