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Frequently Asked Questions

ABOUT BYDUREON (exenatide extended-release for injectable suspension)

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 cancers. 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

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 taking 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 take, 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.

Especially tell your healthcare provider if you take 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, along with diet and exercise, may help lower blood sugar levels in adults with type 2 diabetes.

In a 24-week clinical trial of 252 adults with type 2 diabetes, people using BYDUREON:

  • lowered their A1C levels by an average of 1.6% (starting A1C: 8.5%), compared with 0.9% for people taking BYETTA (starting A1C: 8.4%)
  • lowered their before-meal blood sugar levels by an average of 25 mg/dL compared with 5 mg/dL for people taking BYETTA
  • also, lost an average of 5 pounds, compared to an average of 3 pounds for people taking BYETTA

It is important to note that BYDUREON is not a weight-loss medicine, and not all people that use BYDUREON will lose weight.

Follow your healthcare provider's instructions for diet, exercise, how often to test your blood sugar, and when to get your A1C checked. If you see your blood sugar increasing during treatment with BYDUREON, talk to your healthcare provider, because you may need to adjust your current treatment plan.

How should I use BYDUREON?

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

Use BYDUREON exactly as your healthcare provider tells you to.

BYDUREON is a subcutaneous injection taken once every 7 days (weekly) anytime during the day. Inject BYDUREON into your skin exactly the way your healthcare provider told you to. You can take the injection in your stomach area (abdomen), your thigh, or the back of your upper arm. Each week you can use the same area of your body. But be sure to choose a different injection site in that area. You can use BYDUREON with or without food.

Your healthcare provider must teach you how to inject 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.

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

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

BYETTA is a different form of the same medicine that is in BYDUREON, so do not take 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.

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 take 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. Take your BYDUREON on Friday, as scheduled. Because Sunday is less than 3 days from your original dosing day, you should take 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 using BYDUREON on your dosing day, take 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 take your next dose on your regular dosing day. Don’t take 2 doses less than 3 days apart.

HOW DO I PREPARE AND INJECT MY DOSE?

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

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?

How to attach the needle - BYDUREON

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?

How to remove the needle - BYDUREON

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 take 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.

SIDE EFFECTS

What are the possible side effects of BYDUREON?

For serious side effects that may happen in people who use BYDUREON, see "What is the most important information I should know about BYDUREON?"

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 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. If you experience persistent severe abdominal pain, with or without vomiting, this could be a symptom of acute pancreatitis. Promptly discontinue BYDUREON and contact your healthcare provider.

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
  • 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. Your bump may be smaller or larger, but should go 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.

Bump at injection site

SUPPORT

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

Call our toll-free support line during our business hours, 7 days a week, at 1-866-783-1195 to speak with a live BYDUREON specialist who can walk you through your injection and answer your questions.

STORAGE AND HANDLING

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).

Financial Support for the purchase of BYDUREON

WHAT IS BYDUREON® (exenatide extended-release for injectable suspension)?

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.

IMPORTANT SAFETY INFORMATION for BYDUREON

  • 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 take, as taking them with BYDUREON may affect how each medicine works. Tell your healthcare provider if you take 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.

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.

Please click here for Medication Guide, and click here for US Full Prescribing Information for BYDUREON 2 mg, including Boxed WARNING about possible thyroid tumors including thyroid cancer.

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Just Starting BYDUREON?

How to use BYDUREON and Injection Support

  • To view a video or print instructions about how to inject BYDUREON, click here
  • To speak with one of our trained professionals, call 1-866-783-1195 or click here
  • Learn more about our team of Clinical Educators ready to assist you

Questions About BYDUREON Insurance Coverage and Cost?

  • You may be eligible to save on a 28-day supply of BYDUREON. Click here to learn more
  • To check your coverage and co-pay amount for BYDUREON, call Diabetes Access Support
    at 1-800-330-7647

Looking for BYDUREON Product Information?

Get details on how BYDUREON works, possible side effects, and more.

Other Questions?

Visit the FAQ page for answers to some frequently asked questions about BYDUREON.

WHAT IS BYDUREON® (exenatide extended-release for injectable suspension)?

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.

IMPORTANT SAFETY INFORMATION for BYDUREON

  • 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 take, as taking them with BYDUREON may affect how each medicine works. Tell your healthcare provider if you take 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.

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.

Please click here for Medication Guide, and click here for US Full Prescribing Information for BYDUREON 2 mg, including Boxed WARNING about possible thyroid tumors including thyroid cancer.