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Your 1ST Injection

Your healthcare provider should show you how to use BYDUREON before you use it for the first time. Then, when you are ready to administer BYDUREON yourself, the information in this section will help you.

And, remember, if you need help, you can call us 24 hours a day, 7 days a week at 1-844-9BYDPEN (1-844-929-3736) toll-free.

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.

Instructions for Use

We also recommend that you view the videos below before using the BYDUREON Pen or BYDUREON Single-dose Tray.

BYDUREON Step-By-Step Demonstration Videos

BYDUREON PEN VIDEO

SINGLE-DOSE TRAY VIDEO

BYDUREON PEN VIDEO

Watch a step-by-step video on how to use the BYDUREON Pen

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SINGLE-DOSE TRAY VIDEO

Watch a step-by-step video on how to use the BYDUREON Single-dose Tray

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Medication Guide Full Prescribing Information, including Boxed WARNING

Explore this information 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. For assistance, you may also call us toll-free at 1-844-929-3736.

Learn More About Where and When to Use BYDUREON

WHERE TO INJECT BYDUREON

Please note that BYDUREON must be injected right after you mix it.

  • Inject BYDUREON under the skin (subcutaneously), not into a muscle or vein, exactly the way your healthcare provider instructed you to. You can do the injection in your stomach area (abdomen), your thigh, or the back of your upper arms
  • After injecting with the BYDUREON Pen, make sure you hold the needle in your skin for 10 seconds to get the full dose
  • Each week you can use the same general area of your body. Just be sure not to inject in the exact same place

About injection site bumps

After injecting BYDUREON, you may see or feel a small, raised bump at the injection site within 2-4 weeks (see visual below). This is your body reacting to the microspheres (tiny particles) that hold the medicine as it works to dissolve them. These bumps usually do not need medical attention and do not interfere with BYDUREON treatment. They generally go away on average within 4 weeks.

But keep in mind that these more common bumps are different from serious injection-site reactions which have happened in some people who use BYDUREON. Symptoms of a serious injection site reaction include severe pain, swelling, blisters, an open wound, or a dark scab at the injection site. Some of these injection-site reactions have required surgical intervention. Call your healthcare provider right away if you experience any of these reactions.

You may see or feel a small, raised bump within 2 to 4 weeks of injecting BYDUREON. The illustration here shows an average bump size. In clinical studies, the bump went away on its own within 3 to 6 weeks. The image is based on healthcare providers' descriptions from clinical studies.

DOSING DAY

  • BYDUREON should be used once every 7 days
  • Take BYDUREON on the same day each week
  • You can take BYDUREON any time of the day, with or without meals

Choosing your dosing day

You can choose to inject your first dose on any day of the week. Then, you’ll need to 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 that best fits into your weekly schedule and is easy to remember. It can help to choose a dosing day and time 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 nights.

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.

For instance, if you wanted to change your dosing day from Friday to Sunday, you would:

  • Inject your dose of BYDUREON on Friday
  • Wait 7 days until the following Friday
  • Inject your dose again two days later on Sunday
  • Continue to inject your dose of BYDUREON every Sunday after that
When to inject BYDUREON

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, and inject your dose on that day. Don’t inject 2 doses less than 3 days apart.

HOW TO STORE AND DISPOSE OF BYDUREON

Storage

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

  • 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 and the single-dose pen out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks

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

WHERE TO INJECT BYDUREON

Please note that BYDUREON must be injected right after you mix it.

  • Inject BYDUREON under the skin (subcutaneously), not into a muscle or vein, exactly the way your healthcare provider instructed you to. You can inject in your stomach area (abdomen), your thigh, or the back of your upper arms
  • After injecting with the BYDUREON Pen, make sure you hold the needle in your skin for 10 seconds to get the full dose
  • Each week you can use the same general area of your body. Just be sure not to inject in the exact same place

About injection site bumps

After injecting BYDUREON, you may see or feel a small, raised bump at the injection site within 2-4 weeks (see visual below). This is your body reacting to the microspheres (tiny particles) that hold the medicine as it works to dissolve them. These bumps usually do not need medical attention, and do not interfere with BYDUREON treatment. They generally go away on average within 4 weeks.

But keep in mind that these more common bumps are different from serious injection-site reactions which have happened in some people who use BYDUREON. Symptoms of a serious injection site reaction include severe pain, swelling, blisters, an open wound, or a dark scab at the injection site. Some of these injection-site reactions have required surgical intervention. Call your healthcare provider right away if you experience any of these reactions.

Where to inject BYDUREON

The illustration here shows an average bump size. In a clinical study, the bump went away on its own on average within 4 weeks. The image is based on healthcare providers' descriptions from clinical studies.

DOSING DAY

  • BYDUREON should be used once every 7 days
  • Take BYDUREON on the same day each week
  • You can take BYDUREON any time of the day, with or without meals

Choosing your dosing day

You can choose to inject your first dose on any day of the week. Then, you’ll need to 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 that best fits into your weekly schedule and is easy to remember. It can help to choose a dosing day and time 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 nights.

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.

For instance, if you wanted to change your dosing day from Friday to Sunday, you would:

  • Inject your dose of BYDUREON on Friday
  • Wait 7 days until the following Friday
  • Inject your dose again two days later on Sunday
  • Continue to inject your dose of BYDUREON every Sunday after that
When to inject BYDUREON

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, and inject your dose on that day. Don’t inject 2 doses less than 3 days apart.

HOW TO STORE AND DISPOSE OF BYDUREON

Storage

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

  • 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 and the single-dose pen out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks

Disposal instructions

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

How to store BYDUREON
  • 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

BYDUREON SIDE EFFECTS

Learn about possible side effects of BYDUREON.

Learn More

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

  • POSSIBLE THYROID TUMORS, INCLUDING CANCER: 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. In animal studies, BYDUREON and medicines that work like it caused thyroid tumors, including thyroid cancer. It is not known if BYDUREON will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

  • Do not use BYDUREON if you or any of your family members have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

  • Do not use BYDUREON if you have had an allergic reaction to exenatide or any of the other ingredients in BYDUREON.

BYDUREON may cause serious side effects, including:

  • Inflammation of the pancreas (pancreatitis). Stop using BYDUREON and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back

  • Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery

  • Kidney problems (kidney failure). Tell your healthcare provider if you have or had kidney problems. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse

  • Stomach problems. Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems digesting food. Other medicines like BYDUREON may cause severe stomach problems. It is not known if BYDUREON causes or worsens stomach problems

  • Serious allergic reactions. Stop using BYDUREON and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing

  • Injection-site reactions. 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 surgery. Call your healthcare provider if you have any symptoms of injection-site reactions, including severe pain, swelling, blisters, an open wound, or a dark scab

The most common side effects with BYDUREON may include nausea, diarrhea, headache, vomiting, constipation, itching at the injection site, a small bump (nodule) at the injection site, and indigestion. Nausea is most common when you first start using BYDUREON, but decreases over time in most people as their body gets used to the medicine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as taking them with BYDUREON may affect how each medicine works.

Before using BYDUREON, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other diabetes medicines, including insulin or sulfonylureas.

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 for 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 choice of medicine for treating diabetes.

BYDUREON is not a substitute for insulin and is not for people with type 1 diabetes or people with diabetic ketoacidosis.

BYDUREON is a long-acting form of the medication in BYETTA® (exenatide) injection so both drugs should not be used at the same time.

It is not known if BYDUREON can be used in people with a history of pancreatitis or if BYDUREON is safe and effective for use in children.

Please click here for Medication Guide, and click here for Full Prescribing Information.

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.