Exenatide

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

Exenatide is an injectable medicine for diabetes that helps control blood sugar levels. This medication helps your pancreas produce insulin more effectively. Byetta is a short-acting version of exenatide.

Byetta is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Byetta is not for treating type 1 diabetes.

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

You should not use this medicine if you have severe kidney disease (or you are on dialysis), or if you have slowed digestion or diabetic ketoacidosis.

You should not use this medicine if exenatide has ever caused you to have low platelet levels in your blood.

Stop using this medicine and call your doctor immediately if you have nausea and vomiting with severe pain in your upper stomach that spreads to your back.

You should not use this medicine if you are allergic to exenatide (Bydureon or Byetta), or if you have:

• severe kidney disease (or if you are on dialysis);
• a severe stomach disorder that causes slow digestion;
• a history of low levels of platelets (blood cells that help your blood to clot) while using exenatide; or
• diabetic ketoacidosis (call your doctor for treatment with insulin).

Tell your doctor if you have ever had:

• kidney disease or a history of kidney transplant;
• a stomach disorder that causes slow digestion;
• pancreatitis; or
• gall stones.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications for both the mother and the baby.

Byetta can make birth control pills less effective. If you take birth control pills, take your pill at least 1 hour before your Byetta injection.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Exenatide is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives, itching; rapid heartbeats; difficulty breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Some people using exenatide have had serious or fatal bleeding due to low levels of platelets (blood cells that help your blood to clot). Stop using Byetta and call your doctor right away if you have unusual bleeding or bruising.

This medicine may cause serious side effects. Stop using this medicine and call your doctor immediately if you have:

• 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, nausea, fast heart rate, and feeling anxious or shaky; or
• kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects of exenatide may include:

• indigestion, nausea, vomiting;
• diarrhea, constipation; or
• itching or a small bump where the medicine was injected.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Byetta is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

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

Byetta is usually injected twice a day, before the morning and evening meals. Do not use after eating a meal. You must use Byetta within 60 minutes (1 hour) before eating. Your Byetta doses should be given at least 6 hours apart.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Byetta 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.

Byetta is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Storing unopened (not in use) Byetta: Keep the medicine in its original container. Refrigerate and use until expiration date. Protect from light.

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

Storing opened (in use) Byetta: Store at room temperature and use within 30 days. Protect from heat and bright light. Do not store the injection pen with a needle attached.

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

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 signs of low blood sugar such as headache, hunger, irritability, dizziness, or feeling shaky.

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

Avoid drinking alcohol. It can lower your blood sugar.

If you take the following medicines, make sure to take them at least 1 hour before you use Byetta:

• an antibiotic; or
• birth control pills.

If you take these medicines with food, have them with a meal or snack that is separate from the times you use Byetta.

Exenatide can make it harder for your body to absorb other medicines you take by mouth. Inform your doctor about all your current medicines and any new ones you start or stop using, especially:

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

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