Exenatide, Injection

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KEY POINTS

• This medicine is given by injection to treat type 2 diabetes. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause thyroid tumors or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antidiabetic; incretin mimetic

Generic and brand names: exenatide, injection; Bydureon; Byetta

What is this medicine used for?

This medicine is given by injection (shots) to treat type 2 diabetes. It is used along with a diet and exercise program to help maintain the proper amount of sugar in the blood. It is not given to take the place of insulin and should not be used to treat type 1 diabetes.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Gallstones
• Gastrointestinal disease such as slow stomach emptying
• High triglyceride levels in the blood
• Hypoglycemic episodes (low blood sugar)
• Kidney disease
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) (tumors in more than 1 gland in your body)
• Pancreatitis
• Problems with alcohol abuse
• Thyroid problems, including thyroid cancer

Tell your healthcare provider if you get sick or injured, or if you are scheduled to have surgery.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Follow exactly any instructions that are supplied in the medicine package. Talk with your healthcare provider for specific instructions. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18 years.

The shots are given just under the skin in your abdomen, upper arm, or thigh. Do NOT inject this medicine into a vein or muscle. Follow your healthcare provider's instructions carefully.

Byetta is injected up to 1 hour before your 2 main meals each day (at least 6 hours apart). This medicine should not be given after a meal. If you also take medicines such as birth control pills or antibiotics, take them at least 1 hour before you use this medicine. Do not take birth control pills or antibiotics with the same meal or snack when you use this medicine. Take them with a meal or snack when you do NOT take this medicine

Bydureon is injected once every 7 days. Do not take 2 doses of the extended-release medicine less than 3 days apart. You can take Bydureon at any time during the day with or without food. Inject the medicine right after you mix it.

If you switch from Byetta to Bydureon, follow your healthcare provider’s instructions about when to stop taking Byetta and when to start taking Bydureon. Bydureon is a long-acting form of the same medicine in Byetta. Do not use Bydureon and Byetta together. When you first change from Byetta to Bydureon, your blood sugar levels may be higher than usual and should get better in about 2 weeks. Talk with your healthcare provider about this.

If you do not understand how to use the medicine, ask your healthcare provider or pharmacist to demonstrate.

Your healthcare provider may adjust the dose of your other diabetes medicines while you are taking this medicine. Tell your healthcare provider about all the medicines you take.

Do not mix this medicine with insulin. Never share needles, pens, or delivery devices with anyone else.

What if I miss a dose?

If you use Byetta and miss a dose, skip the missed dose and take your next one at the next prescribed time.

If you miss a dose of Bydureon and your next scheduled dose is less than 2 days away, skip the missed dose and take your next one at the next prescribed time.

Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: severe nausea, vomiting, diarrhea, headache, weakness, dizziness, confusion, flushing, irritability, hunger, fast heartbeat, sweating, tremors.

What should I watch out for?

This medicine may cause serious injection site reactions. Call your healthcare provider right away if you have any of these symptoms at your injection site:

• Severe pain or swelling
• Blisters
• An open wound or dark scab

When you start taking this medicine it is likely to cause nausea, gas, bloating, and diarrhea. This is normal and should go away as your body adjusts to the medicine. Follow the diet prescribed by your healthcare provider to reduce these side effects. Call your healthcare provider right away if you have unexplained, severe stomach pain with or without vomiting, or nausea, vomiting, or diarrhea that will not go away, or if you cannot take liquids by mouth. These may be signs of serious side effects.

This medicine may cause thyroid tumors. While taking this medicine, if you develop a lump in the neck, hoarseness, trouble swallowing, or shortness of breath, contact your healthcare provider right away.

Follow the diet and exercise program prescribed by your healthcare provider. Eat regular meals and do not skip meals, even when you travel or are sick. Your dosage of this medicine is based on your food intake. Also, your blood sugar and A1c must be tested regularly. Follow your healthcare provider's advice exactly.

Alcohol may affect your response to medicine and food. Do not drink alcohol unless your healthcare provider approves.

Low blood sugar (hypoglycemia) can happen if you miss or delay meals, drink too much alcohol, use too much of this medicine or too much insulin, or exercise more than usual. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or gels (available in drug stores) is another quick way to treat low blood sugar.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you are a diabetic and need special care.

This medicine may make you dizzy or drowsy. Also, low blood sugar may affect your ability to drive or operate machinery. Do not drive or operate machinery unless you are fully alert and can see clearly.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Symptoms of hypoglycemia (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness); nausea, vomiting, or diarrhea that is severe or does not go away; severe stomach or back pain; trouble urinating or decreased urination; a lump in the neck, hoarseness, trouble swallowing, or shortness of breath.

Other: Mild nausea or vomiting, heartburn, loss of appetite, change in sense of taste, minor weight loss, constipation, diarrhea, gas, bloating, tiredness, dizziness, drowsiness, mild headache, feeling jittery, redness, or pain at the spot where an injection has been given.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Lovastatin (Altoprev)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other diabetes medicines such as chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, nateglinide (Starlix), repaglinide (Prandin), and tolbutamide
• Warfarin (Coumadin)

Do not drink large amounts of alcohol while you are taking this medicine. Talk to your healthcare provider about this.

This medicine may affect the way that your body absorbs other medicines that you take by mouth. Talk with your healthcare provider about this.

If you also take medicines such as birth control pills or antibiotics, take them at least 1 hour before you use this medicine.

Many nonprescription products contain sugar, alcohol, or other ingredients that may interfere with this medicine or increase your blood sugar. Check product labels for warnings for diabetics or ask your healthcare provider or pharmacist for advice.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

If you use Byetta, refrigerate the unused pen but do not freeze it. After first use, you may store the pen at room temperature away from heat and bright light. Do not store the pen with the needle attached. Discard the pen after 30 days, even if some medicine is left in the pen.

If you use Bydureon, refrigerate the medicine but do not freeze it. If needed, you may store a single-dose tray at room temperature for up to 4 weeks. Protect it from heat, high humidity, and bright light.

Put used needles in rigid puncture-resistant containers with lids or caps, such as heavy plastic bleach bottles with screw caps. DO NOT throw needles directly into garbage cans or dumpsters.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.