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BYDUREON FAQs

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

About BYDUREON

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

Serious side effects may happen in people who use BYDUREON, including:

  • 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).

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 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.

Who should not use BYDUREON?

Do not use BYDUREON if:

  • you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • you are allergic to exenatide or any of the ingredients in BYDUREON. See the end of this Medication Guide for a complete list of ingredients in BYDUREON.

What should I tell my healthcare provider before using BYDUREON?

Before using BYDUREON, tell your healthcare provider if you:

  • have or have had problems with your pancreas, kidneys, or liver.
  • have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. It is not known if BYDUREON will harm your unborn baby. Tell your healthcare provider if you become pregnant while using BYDUREON.
  • are breastfeeding or plan to breastfeed. It is not known if BYDUREON passes into your breast milk. You should not use BYDUREON while breastfeeding without first talking with your healthcare provider.

Pregnancy Registry: There is a registry 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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BYDUREON may affect the way some medicines work and some medicines may affect the way BYDUREON 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 medicines to treat diabetes including insulin or sulfonylureas.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when 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 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.

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.

Dosing

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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.)

Changing your dosing day

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.

Side Effects

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What are the possible side effects of BYDUREON?

BYDUREON may cause serious side effects, including:

  • See "What is the most important information I should know about BYDUREON?"
  • inflammation of your 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 lightheadedness
    • blurred vision
    • anxiety, irritability, or mood changes
    • sweating
    • slurred speech
    • hunger
    • confusion or drowsiness
    • shakiness
    • weakness
    • headache
    • fast heartbeat
    • feeling jittery
  •  
  • kidney problems (kidney failure). 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. 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 an injection-site reaction, including severe pain, swelling, blisters, an open wound, a dark scab.

The most common side effects of BYDUREON may 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 possible 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

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, 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 or insulin.

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 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.

Information about small, raised bumps

Support

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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 1-844-9BYDPEN (1-844-929-3736) to speak with a live BYDUREON Care Partner who can walk you through your injection and answer your questions.

 

BYDUREON Single-dose Tray

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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?

Illustration of 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?

Illustration of removing the needle cover

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).

BYDUREON Pen

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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.

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