Exenatide Injection

Exenatide extended-release injection (Bydureon BCISE) may increase the risk that you will develop tumors of the thyroid gland, including medullary thyroid carcinoma (MTC; a type of thyroid cancer). Laboratory animals who were given exenatide extended-release injection developed tumors, but it is not known if this medication increases the risk of tumors in humans. Tell your doctor if you or anyone in your family has or has ever had MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2; condition that causes tumors in more than one gland in the body). If so, your doctor will probably tell you not to use exenatide extended-release injection. If you experience any of the following symptoms, call your doctor immediately: a lump or swelling in the neck; hoarseness; difficulty swallowing; or shortness of breath.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to exenatide.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with exenatide injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using exenatide injection.

Exenatide is used along with diet and exercise 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) in adults (Byetta) and in adults and children 10 years of age and older (Bydureon BCISE). 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.

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Exenatide immediate-release (Byetta^®) comes as a solution (liquid) in a prefilled dosing pen to inject subcutaneously (just under the skin). Exenatide extended-release (long-acting) (Bydureon^® BCISE) comes as a suspension (liquid) in a prefilled autoinjector to inject subcutaneously. Exenatide immediate-release solution is usually injected twice a day within 60 minutes before the morning and evening meals (or the two main meals of the day, approximately 6 hours apart). Do not inject it after meals. Your doctor will probably start you on a low dose of exenatide immediate-release injection 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. Exenatide extended-release suspension is injected once weekly at any time of day without regard to meals. Use exenatide extended-release on the same day each week at any time of day. You may change the day of the week that you use exenatide extended-release suspension if it has been 3 or more days since you used your last dose. 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 products exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

If you are changing from exenatide immediate-release solution to exenatide extended-release suspension, your glucose (sugar) levels may temporarily increase for 2 to 4 weeks after this change.

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.

Be sure to read and understand the manufacturer's instructions for injecting exenatide injection products. Ask your doctor or pharmacist to show you how to use the pen or autoinjector. Follow these directions carefully.

If you are using exenatide immediate-release (Byetta^®) prefilled dosing pens, you will need to buy needles separately. Ask your doctor or pharmacist what type of needles you will need to inject your medication. Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Dispose of needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture resistant container.

Always look at your exenatide immediate-release solution before you inject it. It should be as clear, colorless, and free of particles. Do not use exenatide immediated-release injection if it is colored, cloudy, contains solid particles, or if the expiration date has passed.

Remove the exenatide extended-release (Bydureon BCISE^®) prefilled autoinjector from the refrigerator and allow it warm to room temperature for 15 minutes before you inject the medication. Mix the prefilled autoinjector by shaking vigorously for at least 15 seconds before use.

Always look at your exenatide extended-release suspension before you inject it. After shaking for 15 seconds, it should white to off-white and cloudy. Do not use if it is discolored, contains solid particles, or if the expiration date has passed.

Do not mix insulin with exenatide products to combine into a single injection.

Exenatide injection products can be administered in the thigh (upper leg), abdomen (stomach), or upper arm. Never inject exenatide into a vein or muscle. Change (rotate) the injection site within the chosen area with each dose of the exenatide extended-release suspension.

You can inject extended release exenatide and insulin in the same general area of the body, but the injections should not be given right next to each other.

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

Before using exenatide injection,

• tell your doctor and pharmacist if you are allergic to exenatide, any other medications, or any of the ingredients in exenatide injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using exenatide injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription product may interact with exenatide: acetaminophen. Be sure to let your doctor and pharmacist know that you are taking this medication before you start using exenatide. Do not start this medication while using exenatide without discussing with your healthcare provider.
• if you are taking oral contraceptives (birth control pills) or antibiotics, take them at least 1 hour before you use exenatide immediate-release solution 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 immediate-release solution injection.
• tell your doctor if you have ever had serious bleeding due to thrombocytopenia (a low number of platelets [type of blood cell needed for blood clotting]) after receiving exenatide products. Your doctor will probably tell you not to use exenatide products.
• tell your doctor if you have had a kidney transplant or if you have or have ever had severe stomach problems, including gastroparesis (slowed movement of food from the stomach to the small intestine) or other problems digesting food; pancreatitis (swelling of the pancreas) or other pancreas problems; gallstones (solid deposits that form in the gallbladder) or other gall bladder problems; high level of triglycerides (fats) in the blood; or liver or kidney disease. Also tell your doctor if you have recently had diarrhea, nausea, or vomiting or if you cannot drink liquids by mouth, which may cause dehydration (loss of a large amount of body fluids).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using exenatide, call your doctor.

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

If you miss a dose of exenatide immediate-release injection (Byetta^®), skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

If you miss a dose of exenatide extended-release injection (Bydureon BCISE^®), use the missed dose as soon as you remember it and then continue your regular weekly schedule. However, if there are less than 3 days (72 hours) until your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

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.

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

• nausea
• vomiting
• diarrhea
• constipation
• decreased appetite
• jittery feeling
• dizziness
• heartburn
• headache
• weakness
• sweating

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNINGS section, stop using exenatide and call your doctor immediately or get emergency medical treatment: :

• ongoing pain that begins in the upper left or middle of the stomach but may spread to the back with or without vomiting
• hives
• rash
• itching
• swelling of the face, throat, tongue, lips, or eyes
• dizziness or fainting
• rapid heartbeat
• difficulty breathing or swallowing
• injection-site pain, swelling, blisters, itching, or nodules
• pain in the right or upper middle stomach area, nausea, vomiting, fever, or yellowing of skin or eyes
• changes in the color or amount of urine
• urinating more or less often than usual
• swelling of the arms, hands, feet, ankles, or lower legs
• unusual bleeding or bruising

Exenatide may cause other side effects. Call your doctor if you have any unusual problems while using 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Store unused exenatide immediate-release pens in their original carton in the refrigerator, protected from light. Do not freeze. Once in use, exenatide immediate-release pens can be stored at room temperature (up to 77°F [25°C]) for up to 30 days. Do not store exenatide pens with the needle attached. When traveling, be sure to keep exenatide immediate-release pens dry.

Store exenatide extended-release autoinjectors flat in the refrigerator in the original carton and protected from light. If needed, exenatide extended-release autoinjectors can be stored at room temperature (up to 80°F [30°C]) for a total of 4 weeks.

Keep exenatide pens and autoinjectors out of the reach of children.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea
• vomiting
• symptoms of hypoglycemia

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.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Bydureon^®¶
• Bydureon BCISE^®
• Byetta^®