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

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

This medication guide provides information about the Byetta, an immediate-release brand of exenatide. Bydureon is an extended-release brand of exenatide that is not covered in this medication guide.

You should not use Byetta 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 Byetta has ever caused you to have low platelet levels in your blood.

Stop using this medicine and call your doctor at once if you have nausea and vomiting with severe pain in your upper stomach spreading to your back.

You should not use Byetta together with fast-acting or short-acting insulins. Do not use this medicine together with Bydureon.

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

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 injections 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.

Exenatide can lower your platelet counts for up to 10 weeks after you stop using Byetta. 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) pens: Keep the medicine in its original container. Refrigerate and use until expiration date. Protect from light.

Do not freeze. Throw away the medicine if it has been frozen.

Storing opened (in use) pens: 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.

Usual Adult Dose for Diabetes Type 2:

Immediate-release (Byetta):
Initial dose: 5 mcg subcutaneously twice a day within the 60-minute period before the morning and evening meals
-Maintenance dose: After 1 month, may increase dose to 10 mcg subcutaneously twice a day based on clinical response
-Maximum dose: 10 mcg twice a day
-Alternatively, may give before the two main meals of the day provided dosing is 6 hours or more apart

Comments:
-This drug has not been studied in patients with a history of pancreatitis and therefore, other therapies should be considered in these patients.
-Extended-release exenatide is not recommended as first-line therapy because of the uncertainty of the risk of thyroid C-cell tumors.
-Patients may experience transient (approximately 2 to 4 weeks) elevation in blood sugar when switching from immediate-release exenatide to extended-release.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

You should not use Byetta if you are allergic to exenatide, 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).

To make sure Byetta is safe for you, 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 in both the mother and the baby.

Exenatide 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.

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

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

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

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

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

Some people using exenatide have had serious or fatal bleeding caused by 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.

Stop using Byetta and call your doctor at once 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 Byetta side effects 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.

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

• an antibiotic; or

• birth control pills.

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

Exenatide can make it harder for your body to absorb other medicines you take by mouth. Tell your doctor about all your current medicines and any 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 interact with exenatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.