Exenatide Extended-Release Injection (Bydureon BCise)

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

• If you have an allergy to exenatide or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Acidic blood problem, type 1 diabetes, pancreas swelling, or stomach or bowel problems.
• If you have kidney problems.
• If you are using insulin.
• If you are using another drug that has the same drug in it.
• If the patient is a child. This medicine is not approved for use in children.

This is not a list of all drugs or health problems that interact with exenatide extended-release injection.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take exenatide extended-release injection. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Wear disease medical alert ID (identification).
• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• Check your blood sugar as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with exenatide extended-release injection.
• It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
• Talk with your doctor before you drink alcohol.
• Do not share with another person even if the needle has been changed. Sharing your tray or pen may pass infections from one person to another. This includes infections you may not know you have.
• Kidney problems have happened with this medicine. Some people have needed dialysis or a kidney transplant. Talk with the doctor.
• Very bad skin problems have happened where the shot was given. Sometimes surgery was needed for these skin problems. Talk with the doctor.
• If you are 65 or older, use exenatide extended-release injection with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Dizziness or passing out.
• Very bad headache.
• Very bad irritation where the shot was given.
• Area that feels hard, blisters, dark scab, lumps, open wound, pain, swelling, or other very bad skin irritation where the shot was given.
• Low blood sugar can happen. The chance of low blood sugar may be raised when this medicine is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
• Very bad and sometimes deadly pancreas problems (pancreatitis) have happened with exenatide extended-release injection. Call your doctor right away if you have very bad stomach pain, very bad back pain, or very upset stomach or throwing up.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Headache.
• Small bump where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.