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How to Use BYDUREON

Before preparing and injecting BYDUREON, first read the Instructions for Use. This is a step-by-step guide that comes with your prescription and includes easy-to-follow pictures of the process. Follow the instructions completely and carefully each time you use BYDUREON.

Explore the tabs below to learn more about where and when to use BYDUREON. You can also learn about proper storage and disposal. If at any time you have questions about your BYDUREON treatment, talk to your healthcare provider.

Inject BYDUREON under the skin (subcutaneously), not into a muscle or a vein. You can administer the injection in your stomach area (abdomen), your thigh, or the back of your upper arms. Each week you can use the same general area of your body. Just be sure not to inject in the exact same place.

You may notice itching or redness at the injection site. Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use BYDUREON. Some of these injection-site reactions have required surgical intervention. Call your healthcare provider right away if you have severe pain, swelling, blisters, an open wound, or a dark scab at your injection site.

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BYDUREON should be used once every 7 days.

Choosing Your Dosing Day

You can choose to inject your first dose on any day of the week. Then you'll inject it on the same day each week. This is your "dosing day." You can inject BYDUREON at any time during your dosing day, with or without food.

Try to select a day and time that best fits into your weekly schedule and is easy to remember. It can help to choose a dosing day that is linked to a regular weekly activity. For example, if you have a favorite TV show you watch on Friday nights, you could plan to inject your BYDUREON dose on Friday.

Changing Your Dosing Day

If you want to change your dosing day, you can. When changing the dosing day, you can choose any day you want; however, the next dose must be injected at least 3 days after the previous dose. Do not inject 2 doses of BYDUREON less than 3 days apart.

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Example: How to change your dosing day from Friday to Sunday.

For example, let's say you want to change your dosing day from Friday to Sunday. Give yourself a dose of BYDUREON on Friday, as scheduled. Because Sunday is less than 3 days from your original dosing day, you should inject your next dose of BYDUREON on the following Sunday (see calendar above).

Once you've selected a dosing day that works for you, try to stay with it. It's not a good idea to change your dosing day often.

Missing an Injection

If you miss an injection of BYDUREON on your dosing day, give yourself an injection as soon as you can, unless your next dosing day is 1 or 2 days away. In that case, wait until your next regular dosing day. Then inject your next dose on your regular dosing day. Don't inject 2 doses less than 3 days apart.

It is important that you carefully follow all storage instructions for BYDUREON.

Storage

  • BYDUREON should be stored in your refrigerator at 36°F to 46°F (2°C to 8°C) and protected from light until prepared for use
  • Do not freeze BYDUREON. Do not use BYDUREON if it has been frozen
  • Do not use BYDUREON past the expiration date
  • Keep BYDUREON, and all medicine, out of reach of children
  • If needed, you can keep the BYDUREON single-dose tray out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks
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Disposal Instructions

Proper disposal of needles is important for your safety and the safety of those around you.

  • Use a biohazard container made specifically for disposing of used injection devices (called a “sharps” container) or a puncture-resistant container to throw out the device with the needle still attached. To avoid a needlestick injury, do not put the cover back on the needle.
  • Throw away all other parts in the trash. You do not have to save them.
  • Check with your healthcare provider or pharmacist for instructions about the right way to dispose of used injection devices. There may be special local or state laws about how to dispose of used injection devices and/or puncture-resistant containers.
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Important Safety Information for BYDUREON® (exenatide extended-release for injectable suspension)

  • POSSIBLE THYROID TUMORS, INCLUDING CANCER: In animal studies, BYDUREON caused rats to develop tumors of the thyroid gland. Some of these tumors were cancer. It is not known if BYDUREON causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. Do not use BYDUREON if you or any of your family members have MTC or if you have Multiple Endocrine Neoplasia syndrome type 2. While using BYDUREON, tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
  • Do not use BYDUREON if you have had an allergic reaction to exenatide or any of the other ingredients in BYDUREON. Severe allergic reactions can happen with BYDUREON. Symptoms of a severe allergic reaction to BYDUREON are severe rash or itching, swelling of your face, lips, and throat that may cause difficulty breathing or swallowing, feeling faint or dizzy, and very rapid heartbeat. If you have any symptoms of a severe allergic reaction, stop using BYDUREON and call your healthcare provider right away.
  • Inflammation of the pancreas (pancreatitis) may happen, which may be severe and lead to death. Before using BYDUREON, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. Stop using BYDUREON and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away, occurs with or without vomiting, or is felt going from your stomach area through to your back. These may be symptoms of pancreatitis.
  • Your risk for getting low blood sugar (hypoglycemia) is higher if you use BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea may need to be lowered while you use BYDUREON. Signs and symptoms of low blood sugar may include shakiness, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.
  • Tell your healthcare provider if you have or had kidney problems or a kidney transplant. BYDUREON may cause nausea, vomiting, or diarrhea, leading to loss of fluids (dehydration). Dehydration may cause kidney failure; this can happen in people who have never had kidney problems before. Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away or if you cannot drink liquids.
  • Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
  • Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use BYDUREON. Some of these injection-site reactions have required surgical intervention. Call your healthcare provider right away if you have severe pain, swelling, blisters, an open wound, or a dark scab at your injection site.
  • The most common side effects with BYDUREON include nausea, diarrhea, headache, vomiting, constipation, itching at injection site, a small bump (nodule) at the injection site, and indigestion. Nausea most commonly happens when first starting BYDUREON, but may become less over time.
  • Before using BYDUREON, tell your doctor about all the medicines you use, as using them with BYDUREON may affect how each medicine works. Tell your healthcare provider if you use other diabetes medicines, especially insulin or a sulfonylurea, or warfarin sodium (Coumadin® or Jantoven®).
  • Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYDUREON will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.

Approved Uses

BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise. BYDUREON is not recommended as the first medication to treat diabetes.

BYDUREON is a long-acting form of the medication in BYETTA® (exenatide) injection so both drugs should not be used together. BYDUREON is not a substitute for insulin and has not been studied in combination with insulin. BYDUREON is not for people with type 1 diabetes or people with diabetic ketoacidosis (a condition caused by very high blood sugar). BYDUREON is not recommended for use in children. It is not known if BYDUREON is safe and effective in people with a history of pancreatitis or severe kidney problems.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Please read the Important Safety Information on this page and tap the ACCEPT button at the bottom to enter the BYDUREON website.

Important Safety Information for BYDUREON® (exenatide extended-release for injectable suspension)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What Is BYDUREON?

BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise. BYDUREON is not recommended as the first medication to treat diabetes.

BYDUREON is a long-acting form of the medication in BYETTA® (exenatide) injection so both drugs should not be used together. BYDUREON is not a substitute for insulin and has not been studied in combination with insulin. BYDUREON is not for people with type 1 diabetes or people with diabetic ketoacidosis (a condition caused by very high blood sugar). BYDUREON is not recommended for use in children. It is not known if BYDUREON is safe and effective in people with a history of pancreatitis or severe kidney problems.

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Important Safety Information