page banner page banner

BYDUREON FAQs

Get answers to some frequently asked questions about BYDUREON, including the BYDUREON Single-dose Tray and the BYDUREON Pen.

Expand All

About BYDUREON

What is the most important information I should know about BYDUREON?

Serious side effects may happen in people who use BYDUREON, including:
  1. Possible thyroid tumors, including cancer. During the drug testing process, the medicine in BYDUREON caused rats to develop tumors of the thyroid gland. Some of these tumors were cancer. It is not known if BYDUREON will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people.

    Before you start using BYDUREON, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2. Do not use BYDUREON if you or any of your family members have medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not use BYDUREON.

    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.

  2. Inflammation of the pancreas (pancreatitis), 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
    • high blood triglyceride levels

    These medical conditions can make you more likely to get pancreatitis. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while using BYDUREON.

    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. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.

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.

Who should not use BYDUREON?

Do not use BYDUREON if:

  • you or any of your family members have a history of medullary thyroid cancer
  • you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body
  • you are allergic to exenatide or any of the ingredients in BYDUREON. Symptoms of a severe allergic reaction may include swelling of your face lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat

Talk to your healthcare provider before using this medicine if you have any of these conditions.

What should I tell my healthcare provider before using BYDUREON?

Before using BYDUREON, tell your healthcare provider if you:
  • have any of the conditions listed in the section "What is the most important information I should know about BYDUREON?"
  • have severe problems with your stomach such as slow emptying of your stomach (gastroparesis) or problems digesting food
  • have or have had kidney problems, or have had a kidney transplant
  • have any other medical conditions
  • are pregnant or are planning to become pregnant. It is not known if BYDUREON may harm your unborn baby. Tell your healthcare provider if you become pregnant while using BYDUREON
  • Pregnancy Registry: A registry has been implemented for women who use BYDUREON during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you use BYDUREON at any time during pregnancy, you may enroll in this registry by calling 1-800-633-9081.
  • are breastfeeding or plan to breastfeed. It is not known if BYDUREON passes into your breast milk. You and your healthcare provider should decide if you will use BYDUREON or breastfeed. You should not do both without talking with your healthcare provider first

Tell your healthcare provider about all of the medicines you use, including prescription and nonprescription medicines, vitamins, and herbal supplements. BYDUREON may affect the way some medicines work and some other medicines may affect the way BYDUREON works.

Tell your healthcare provider if you use other diabetes medicines, especially insulin or sulfonylurea, any medicine taken by mouth, or warfarin sodium (Coumadin®, Jantoven®).

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How can BYDUREON help me?

BYDUREON is clinically proven to significantly lower A1C and help with weight loss.*

BYDUREON is not a weight-loss drug. Individual results may vary.

*

In a 24-week study, adults with type 2 diabetes taking BYDUREON 2 mg with diet and exercise alone or with other diabetes pills, lowered A1C by an average of 1.6% (starting at 8.5%) and additionally reduced weight by an average of 5 pounds (starting at 214 pounds). BYDUREON is not a weight loss product. Individual results may vary.

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.

What if I'm using BYETTA and my doctor prescribes BYDUREON?

If you are using BYETTA and your healthcare provider prescribed BYDUREON, you should follow your healthcare provider's instructions about when to stop using BYETTA and when to start using BYDUREON.

BYETTA is a different form of the same medicine that is in BYDUREON, so do not use BYETTA when you are using BYDUREON. 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.

Expand All

Dosing

How do I change my dosing day?

You only need to use BYDUREON once every 7 days. If you want to change your dosing day, you can. Your new dosing day must be at least 3 days after your last dose. Do not inject 2 doses of BYDUREON less than 3 days apart.

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 below.)

dosing calendar

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.

What should I do if I miss a dose?

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.

Expand All

Side Effects

What are the possible side effects of BYDUREON?

BYDUREON can cause serious side effects, including:
  • See "What is the most important information I should know about BYDUREON?"
  • Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you use BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while you use BYDUREON. Signs and symptoms of low blood sugar may include:
    • shakiness
    • sweating
    • headache
    • irritability
    • drowsiness
    • hunger
    • weakness
    • fast heartbeat
    • dizziness
    • feeling jittery
    • confusion
  • Kidney problems (kidney failure). BYDUREON may cause nausea, vomiting or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure, which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away, or if you cannot drink liquids by mouth
  • Severe allergic reactions. Severe allergic reactions can happen with BYDUREON. Stop using BYDUREON, and get medical help right away if you have any symptom of a severe allergic reaction. See "Who should not use BYDUREON?"
  • 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 surgical intervention. Call your healthcare provider right away if you have any of the following at your injection site:
    • severe pain
    • an open wound
    • swelling
    • a dark scab
    • blisters
The most common side effects of BYDUREON include:
  • nausea
  • diarrhea
  • headache
  • vomiting
  • constipation
  • itching at the injection site
  • a small bump (nodule) at the injection site
  • 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.

Talk to your healthcare provider about any side effect that bothers you or does not go away.

These are not all the side effects of BYDUREON. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Will I experience nausea while using BYDUREON?

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. Stop using BYDUREON and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and does not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.

What is my risk for low blood sugar (hypoglycemia) while using BYDUREON?

Your risk for getting low blood sugar is higher if you use BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while you use BYDUREON.

Signs and symptoms of low blood sugar may include:
  • shakiness
  • sweating
  • confusion
  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heartbeat
  • feeling jittery

Talk with your healthcare provider about how to recognize and treat low blood sugar. Make sure that your family and other people around you know how to recognize and treat low blood sugar.

What if I see or feel a small, raised bump at the injection site?

You may see or feel a small, raised bump within 2 to 4 weeks of injecting BYDUREON. The illustration below shows an average bump size. In clinical studies, the bump went away on its own within 3 to 6 weeks. You may also have more than one bump at once, but this can be expected.

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.

Expand All

Support

Where can I get help with preparing my dose or self-injection?

Call our toll-free support line 24 hours a day, 7 days a week at 1-844-929-3736 to speak with a live BYDUREON Care Partner who can walk you through your injection and answer your questions.

Expand All

BYDUREON Single-dose Tray

How should I use the BYDUREON single-dose tray?

For detailed instructions, see the Instructions for Use that comes with your BYDUREON prescription.

  • Your healthcare provider should teach you how to use BYDUREON before you use it for the first time. If you have any questions or do not understand the instructions, talk with your healthcare provider or pharmacist
  • Pay special attention to mixing BYDUREON well, as shown in the Instructions for Use
  • Use BYDUREON exactly as your healthcare provider tells you to
  • You can use BYDUREON with or without food

How soon do I inject after mixing?

You must use BYDUREON immediately after mixing it. If you do not inject BYDUREON right away, the medicine is more likely to clump and clog the needle.

How do I know when the medicine is mixed well?

Push the plunger down with your thumb and shake hard to mix the medicine. When the medicine is mixed well, it should look cloudy. There should not be any dry powder on the sides or bottom of the vial.

If you do see any dry powder, shake hard while continuing to push down on the plunger with your thumb.

Will the small air bubbles in the syringe harm me?

No, small air bubbles will not harm you or affect your dose. BYDUREON is injected into your skin (subcutaneously). Air bubbles are not a problem with this type of injection.

How do I attach the needle?

hands attaching the needle

First, be sure you have removed the blue cap. Then, twist the needle onto the syringe until snug. To prevent losing medicine, do not push in the plunger while attaching the needle.

How do I remove the needle cover?

hands removing needle

With one hand, hold the syringe near the black dashed Dose Line. With your other hand, hold the needle cover. Pull the needle cover straight off. Do not twist it.

What should I do if the top of the plunger has been pushed past the black dashed Dose Line?

The black dashed Dose Line shows the correct dose. If the top of the plunger has been pushed past the line, you should continue and use the injection. But next time, make sure the plunger matches the black dashed Dose Line so you can be sure to get the proper amount of medicine.

What if the plunger doesn't go down when I try to give myself my injection?

You may have a needle clog if the medicine wasn't mixed well or you did not inject BYDUREON right away. That's OK. That's why there is an extra needle in your tray. Twist off the clogged needle, and twist on the extra needle included in your tray. Then pull off the new needle cover to inject.

Why are there two needles in the tray?

One needle is an extra in case you need it. Do not share your BYDUREON tray with another person even if the needle is changed. Sharing your tray with another person can cause you or someone else to get an infection.

How do I travel with this medication?

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. If needed, you can keep a tray out of the refrigerator for up to 4 weeks at a temperature no higher than 77°F (25°C).

Expand All

BYDUREON Pen

How should I use the BYDUREON Pen?

For detailed instructions, see the Instructions for Use that comes with your BYDUREON Pen prescription.

  • Your healthcare provider should teach you how to use BYDUREON before you use it for the first time. If you have any questions or do not understand the instructions, talk with your healthcare provider or pharmacist
  • Pay special attention to mixing BYDUREON well, as shown in the Instructions for Use
  • Use BYDUREON exactly as your healthcare provider tells you to
  • You can use BYDUREON with or without food

How do I switch from BYETTA to the BYDUREON Pen?

BYETTA should be discontinued upon starting the BYDUREON Pen.

Patients formerly on BYETTA who start BYDUREON may experience transient elevations in blood glucose concentrations, which generally improve within the first 2 weeks after initiation of therapy.

How do I switch from the single-dose tray to the pen?

Based on the directions from your doctor you can finish your supply of BYDUREON single dose tray and at your next scheduled dose of BYDUREON you can utilize the BYDUREON Pen.

Can I still get the single-dose tray?

Yes, your doctor will have to write a prescription specific for the single-dose tray.

What is the needle size of the pen?

23G x 9/32 inch (7 mm)

Is the solution in the BYDUREON Pen the same as in the BYDUREON single-dose tray?

Yes. The main ingredient in both the BYDUREON Pen and the BYDUREON single-dose tray is exenatide. The difference between the two devices is that BYDUREON Pen is pre-assembled (you just need to attach the needle) and has fewer preparation steps than the BYDUREON single-dose tray.

How much time does it take to prepare and inject the BYDUREON Pen and how does it compare to the BYDUREON single-dose tray?

Before using BYDUREON, remember to read the Instructions for Use that comes with each prescription.

The time it takes to prepare and inject will vary by user and device. The BYDUREON Pen needs to warm up to room temperature for about 15 minutes prior to use. However, the pen is pre-filled and has fewer preparation steps than the BYDUREON single-dose tray. With both devices, you need to inject immediately after mixing the medicine and with the BYDUREON Pen, hold the needle in your skin for 10 seconds to assure you get your full dose.

Can I use my pen for more than one dose?

No, the pen is not re-usable. After dosing once, place the entire pen in an appropriate sharps container.

Do I need to tap the BYDUREON Pen 80 times?

You may need to tap the pen 80 times or more to make sure the medicine is well mixed. You should rotate your pen every 10 taps. During the mixing process, hold the pen to the light and look through both sides of the mixing window. The medicine is well mixed when it is uniformly cloudy with no clumps. If you see clumps on the sides or top of the plunger, keep tapping longer and more firmly. The medicine needs to be well mixed to ensure that you get the full dose.

  • Start Saving Today!*

    Activate or request your BYDUREON SavingsRx Card here. *Eligibility Requirements and Terms of Use apply.
    GET STARTED
  • If You're Currently Using BYDUREON

    Register to receive ongoing support, tips, and tools to help you stay on BYDUREON.
    REGISTER NOW
  • SteadySTART Program

    Meet with a Clinical Educator in person and learn how to get started with BYDUREON.
    FIND OUT MORE
close isi

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.

close isi logo
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.

Accept
Back to top
Important Safety Information