Exenatide Injection (patient information)

Why this medication is prescribed

Exenatide is used in combination with metformin, a sulfonylurea, or a thiazolidinedione medication to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Exenatide is in a class of medications called incretin mimetics. It works by stimulating the pancreas to secrete insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Exenatide also slows the emptying of the stomach and causes a decrease in appetite. Exenatide is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood). Exenatide is not used instead of insulin to treat people with diabetes who need insulin.

How this medication should be used

Exenatide comes as a solution (liquid) in a prefilled dosing pen to inject subcutaneously (under the skin). It is usually injected twice a day within 60 minutes before the morning and evening meals. Exenatide should not be injected after meals. Your doctor will probably start you on a low dose of exenatide and may switch you to a pen with a higher dose of medication if your blood sugar control has not improved after you have used exenatide for 1 month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use exenatide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Exenatide controls diabetes but does not cure it. Continue to use exenatide even if you feel well. Do not stop using exenatide without talking to your doctor.

Exenatide comes in prefilled dosing pens that contain enough medication for 60 doses (two doses a day for 1 month). You will need to buy needles separately. Ask your doctor or pharmacist what type of needles you will need to inject your medication. Be sure to read and understand the manufacturer's instructions for injecting exenatide using the pen. Also make sure you know how and when to set up a new pen. Ask your doctor or pharmacist to show you how to use the pen. Follow the directions carefully. Never remove the cartridge from the pen or attempt to add any other type of medication to the cartridge.

Always look at your exenatide solution before you inject it. It should be as clear, colorless, and fluid as water. Do not use exenatide if it is colored, cloudy, thickened, or contains solid particles, or if the expiration date on the bottle has passed.

Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Throw away needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture resistant container.

Exenatide can be administered in the thigh (upper leg), abdomen (stomach), or upper arm. Use a different site for each injection, about 1 inch away from the previous injection but in the same general area (for example, the thigh). Use all available sites in the same general area before switching to a different area (for example, the upper arm). Do not use the same injection site more often than once every month.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before using exenatide injection:

• tell your doctor and pharmacist if you are allergic to exenatide or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention warfarin (Coumadin).
• if you are taking oral contraceptives (birth control pills) or antibiotics, take them at least 1 hour before exenatide injection. If you have been told to take these medications with food, take them with a meal or snack at a time when you do not use exenatide.
• tell your doctor if you have or have ever had severe stomach problems or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using exenatide, call your doctor.
• you should know that when exenatide is used in combination with a sulfonylurea medication, it may increase the risk of hypoglycemia (low blood sugar). Ask your doctor or pharmacist if you are not sure if the antidiabetic medication that you are taking is a sulfonylurea. Your doctor may lower your dose of sulfonylurea while you are using exenatide.
• you should know that exenatide may cause weight loss and a decrease in appetite.

Special dietary instructions

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet.

Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using exenatide.

What to do if you forget a dose

Skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

Side effects

Minor side effects

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:

• shakiness
• dizziness or lightheadedness
• sweating
• nervousness or irritability
• sudden changes in behavior or mood
• headache
• numbness or tingling around the mouth
• weakness
• pale skin
• hunger
• clumsy or jerky movements

If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.

• confusion
• seizures
• loss of consciousness

Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar) :

• extreme thirst
• frequent urination
• extreme hunger
• weakness
• blurred vision

If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of the these symptoms:

• dry mouth
• upset stomach and vomiting
• shortness of breath
• breath that smells fruity
• decreased consciousness

Exenatide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• upset stomach
• vomiting
• diarrhea
• jittery feeling
• dizziness
• headache
• weakness
• acid stomach

Severe side effects

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• severe stomach pain
• hives
• skin rash
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness

Exenatide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Store unused exenatide pens in their original carton in the refrigerator protected from light. Once in use, store exenatide pens at room temperature (up to 77° F) protected from light. Do not freeze. Do not use exenatide if it has been frozen. Do not store exenatide pens with the needle attached. Keep exenatide pens out of the reach of children.

When traveling, be sure to keep exenatide pens dry. Unused pens should be refrigerated or at a cold temperature between 36 to 46°F;. pens that are in use can be stored at room temperature up to 77°F (not in a car glove compartment or other hot place).

Make a note of the date you first use an exenatide pen, and throw away the pen after 30 days, even if there is some solution left in the pen. Throw away any exenatide pens that are outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• severe upset stomach
• severe vomiting
• dizziness
• symptoms of hypoglycemia (See "What Side Effects can this medication cause?")

other information

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to exenatide. Your doctor will also tell you how to check your response to this medication by measuring your blood or urine sugar levels at home. Follow these instructions carefully.

See your dentist twice yearly; see your eye doctor regularly; get your blood pressure checked regularly.

Keep yourself and your clothes clean. Wash cuts, scrapes, and other wounds quickly, and do not let them get infected. Wear medical alert identification (a bracelet or tag) that says you have diabetes.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Byetta®