Exenatide

Exenatide

What is Byetta?

Exenatide is an injectable diabetes medication 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 with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Byetta is not suitable for treating type 1 diabetes.

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

Side effects of Byetta

If necessary, get emergency medical helpSigns of an allergic reaction:hives, itching; rapid heartbeat; difficult breathing; dizziness; Swelling of your face, lips, tongue, or throat.

Some patients taking exenatide have experienced serious or fatal bleeding caused by a lack of platelets (blood cells that help blood clot).Stop using Byetta and call your doctor immediately if you experience unusual bleeding or bruising.

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

• Problems with the pancreas or gallbladder – pain in the upper abdomen spreading to the back, nausea and vomiting, fever, fast heartbeat, yellowing of the skin or eyes;

• low blood sugar – headache, hunger, sweating, irritability, dizziness, nausea, fast heartbeat, and feeling anxious or shaking; or

• Kidney problems – little or no urination, painful or difficult urination, swelling of the feet or ankles, tiredness or shortness of breath.

Common side effects of exenatide may include:

• indigestion, nausea, vomiting;

• diarrhea, constipation; or

• Itching or a small bump at the injection site of the medicine.

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

Warnings

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

You should not use this medicine if exenatide has ever caused low blood platelet levels.

Stop using this medication and call your doctor immediately if you experience nausea and vomiting with severe pain in your upper abdomen that spreads to your back.

Before you take this medicine

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 require dialysis);

• a serious stomach disorder that causes slow digestion;

• a history of low levels of platelets (blood cells that help blood clot) while using exenatide; or

• diabetic ketoacidosis (ask your doctor about insulin treatment).

Tell your doctor if you have ever had:

• kidney disease or a history of a kidney transplant;

• a stomach disorder that results in slow digestion;

• pancreatitis; or

• Gallstones.

Follow your doctor's instructions for using this medicineif you are pregnant or become pregnant.Controlling diabetes is very important during pregnancy, and high blood sugar levels can cause complications in both the mother and the baby.

Byetta may cause birth control pills to be less effective. If you are taking birth control pills, take them at least 1 hour before your Byetta injection.

Breastfeeding may not be safe while using this medication. Ask your doctor about any risks.

Exenatide is not approved for use by people under 18 years of age.

How should I use Byetta?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Byetta is injected under the skin. A doctor can teach you how to properly use the medication yourself.

Carefully read and follow all instructions for use that come with your medicine. Ask your doctor or pharmacist if you do not understand all the instructions.

Do not prepare your injection until you are ready to give it. You must give the injection immediately after mixing.

Byetta is usually injected twice daily, before morning and evening meals. Do not use after eating. 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 levels(hypoglycemia)and you feel very hungry, dizzy, irritable, confused, anxious, or shaking. 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 if you have severe hypoglycemia. Make 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 increased urination.

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

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

Never share a hypodermic pen or syringe with another person, even if the needle has been changed. Sharing these devices can spread infections or diseases from one person to another.

Byetta may lower your platelet count for up to 10 weeks after you stop using this medicine. Frequent medical examinations may be necessary while using this medicine and for a short time after you stop using it.

Byetta is just one part of a complete treatment program that may also include diet, exercise, weight control, regular blood glucose testing, and specialized medical care. Follow your doctor's instructions carefully.

Storage unopened (not in use) by Byetta:Store the medicine in the original container. Store in the refrigerator and use until the expiration date. Protect from light.

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

Storage 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 the needle attached.

What happens if I miss a dose?

Skip the missed dose and take the next dose at the regular time. Do not use two doses at the same time.

What happens if I overdose?

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

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

What should I avoid when using Byetta?

You shouldn't mixByettawith insulin in the same syringe.Do not use Byetta with Bydureon.

Avoid alcohol. It can lower your blood sugar.

What other medications affect Byetta?

If you are taking the following medicines, take them at least 1 hour before using Byetta:

• an antibiotic; or

• Birth control pills.

If you take these medicines with food, take them with a meal or snack, separate from the meals with which you take Byetta.

Exenatide can make it harder for your body to absorb other medicines you take by mouth. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping, especially:

• blood pressure medications;

• a diuretic or “water pill”;

• insulin or oral diabetes medications;

• painkillers;

• Lovastatin (Advicor, Altoprev, Mevacor); or

• Warfarin (Coumadin, Jantoven).

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

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Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.