Frequently Asked Questions

Get answers to some frequently asked questions about BYDUREON BCise.

About BYDUREON BCise

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

BYDUREON BCise may cause serious side effects, 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 BCise will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

  • Do not use BYDUREON BCise 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 BCise?

  • BYDUREON BCise 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 BCise is not recommended as the first choice of medicine for treating diabetes

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

  • Do not use BYDUREON, BYDUREON BCise, BYETTA or other medicines containing exenatide together

  • It is not known if BYDUREON BCise can be used in people with a history of pancreatitis

Who should not use BYDUREON BCise?

Do not use BYDUREON BCise 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 BCise. See the Medication Guide for a complete list of ingredients in BYDUREON BCise

What should I tell my healthcare provider before using BYDUREON BCise?

Before using BYDUREON BCise, tell your healthcare provider about all of your medical conditions, including if you:

  • Have or have had problems with your pancreas or kidneys

  • Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food

  • Are pregnant or plan to become pregnant. BYDUREON BCise may harm your unborn baby. Tell your healthcare provider if you become pregnant while using BYDUREON BCise. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant

  • Are breastfeeding or plan to breastfeed. It is not known if BYDUREON BCise passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using BYDUREON BCise

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BYDUREON BCise may affect the way some medicines work and some medicines may affect the way BYDUREON BCise works.

Before using BYDUREON BCise, 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 does one dose of BYDUREON BCise work 7 days?

BYDUREON BCise has convenient once-weekly dosing and an extended-release delivery system. Each dose contains tiny beads that slowly dissolve to continuously release medicine into your body over time, helping your body release its own insulin, when needed, to help lower blood sugar.

After 10 weeks of continued once-weekly dosing, BYDUREON BCise keeps a consistent level of medicine in your body, working for you 7 days a week.

How does BYDUREON BCise work to lower blood sugar?

BYDUREON BCise is not insulin; it is a type 2 diabetes prescription medicine that is slowly released into your body over time, working to help your body release its own insulin when needed to lower blood sugar. This helps lower your blood sugar when you need it.

BYDUREON BCise works with your body to:

  • Help the pancreas release insulin when blood sugar needs to be reduced

  • Prevent the release of a hormone that triggers the liver to make sugar when it’s not needed

  • Slow down how quickly the stomach empties, sending sugar into the bloodstream more slowly

How can BYDUREON BCise help me?

BYDUREON BCise has been proven to help significantly lower A1C along with diet and exercise. Also, although not a weight loss drug, BYDUREON BCise may help you lose some weight.

In one clinical study lasting 28 weeks, BYDUREON BCise lowered A1C by an average of 1.4% from a starting A1C of 8.5% and lowered weight by an average of 3 lb from a starting weight of 213 lb when used alone or with certain oral type 2 diabetes medicines. In a second clinical study, BYDUREON BCise lowered A1C by an average of 1.1% from a starting A1C of 8.4% and lowered weight by an average of 3 lb after 28 weeks from a starting weight of 196 lb when added to metformin. Your results may vary.

How much will BYDUREON BCise lower my A1C?

Because every person is different, it’s impossible to know how well BYDUREON BCise will work in any one person. However, BYDUREON BCise has been proven to help lower A1C in clinical studies along with diet and exercise.

In one clinical study lasting 28 weeks, BYDUREON BCise lowered A1C by an average of 1.4% from a starting A1C of 8.5% and lowered weight by an average of 3 lb from a starting weight of 213 lb when used alone or with certain oral type 2 diabetes medicines. In a second clinical study, BYDUREON BCise lowered A1C by an average of 1.1% from a starting A1C of 8.4% and lowered weight by an average of 3 lb after 28 weeks from a starting weight of 196 lb when added to metformin. Your results may vary.

How long does it take for BYDUREON BCise to lower my blood sugar?

BYDUREON BCise works gradually and continually. As you continue to take your weekly doses, the amount of medicine in your body gradually builds up over 10 weeks until it reaches an optimal level to work in your body. With continued once-weekly dosing, the extended-release delivery system of BYDUREON BCise keeps a consistent level of medicine in your body, ready to work when you need it to help lower your blood sugar.

Remember, you need to continue to take BYDUREON BCise exactly as your doctor or healthcare provider has prescribed it, along with continuing to follow the treatment plan they’ve recommended.

Side Effects

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What are the possible side effects of BYDUREON BCise?

BYDUREON BCise may cause serious side effects, 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 BCise will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

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

  • Inflammation of the pancreas (pancreatitis) Stop using BYDUREON BCise 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 BCise with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Tell your healthcare provider if you take other diabetes medicines. Talk to your healthcare provider about managing low blood sugar. Signs and symptoms of low blood sugar include dizziness or lightheadedness, 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 stomach problems, such as slowed emptying of your stomach (gastroparesis) or problems digesting food. Other medicines like BYDUREON BCise may cause severe stomach problems. It is not known if BYDUREON BCise causes or worsens stomach problems

  • Serious allergic reactions Stop using BYDUREON BCise 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 adverse reactions with BYDUREON BCise include a bump at the injection site and nausea. Other side effects that occur less often include headache, diarrhea, vomiting, injection site itching and redness, dizziness, and constipation. These are not all the possible side effects of BYDUREON BCise. See the Important Safety Information for more information and talk to your healthcare provider if you have any side effects that bother you or do not go away.

Also, talk to your healthcare provider if you have any changes in your medical condition or the medicines you take.

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 BCise?

Nausea is most common when you first start using BYDUREON BCise, but decreases over time in most people as their body gets used to the medicine. In BYDUREON BCise clinical studies, about 1 in 12 people felt nausea.

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

Your risk for getting low blood sugar is higher if you use BYDUREON BCise with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

In clinical studies, serious cases of hypoglycemia occurred in approximately 2% of patients taking BYDUREON BCise, mostly in patients taking a sulfonylurea.

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, or mood changes

  • hunger

  • weakness

  • 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?

Some adults taking BYDUREON BCise can get a small raised bump under their skin at the injection site. This is a normal body response to the tiny beads in BYDUREON BCise that slowly release medicine over time, and the bump usually disappeared in an average of 4 weeks in BYDUREON clinical studies. The illustration below shows an average bump size.

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, or a dark scab.

Illustration showing average bump size from injection

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

Dosing

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How often should I take BYDUREON BCise?

Take BYDUREON BCise just once each week with or without food, on the same day that best fits your busy schedule.

Remember, you need to continue to take BYDUREON BCise exactly as your doctor or healthcare provider has prescribed it, along with continuing to follow the treatment plan they’ve recommended.

How do I change my dosing day?

You only need to use BYDUREON BCise 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 BCise 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 BCise 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 BCise every Sunday after that

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.

How to change your dosing day

What should I do if I miss a dose?

If you miss an injection of BYDUREON BCise 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.

What if I’m using BYDUREON® (exenatide extended-release) and my doctor prescribes BYDUREON BCise?

BYDUREON BCise is a different form of the same medicine, called exenatide extended-release, that is in BYDUREON, so do not use these medicines together.

If you are using BYDUREON or any other exenatide-based product and your healthcare provider prescribes BYDUREON BCise, you should follow your healthcare provider’s instructions about when to stop using BYDUREON and when to start using BYDUREON BCise.

What if I’m using BYETTA® (exenatide) injection and my doctor prescribes BYDUREON BCise?

BYDUREON BCise is a different form of the same medicine, called exenatide, that is in BYETTA, so do not use these medicines together.

If you are using BYETTA or any other exenatide-based product and your healthcare provider prescribes BYDUREON BCise, you should follow your healthcare provider’s instructions about when to stop using BYETTA and when to start using BYDUREON BCise.

When you first change from BYETTA to BYDUREON BCise, your blood sugar levels may be higher than usual and should get better in about 4 weeks.

Using the BYDUREON BCise Device

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How should I use the BYDUREON BCise device?

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

  • Your healthcare provider should teach you how to use BYDUREON BCise 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

  • Use BYDUREON BCise exactly as your healthcare provider tells you to

  • You can take BYDUREON BCise with or without food

You can watch a short instructional video demonstrating how to use the BYDUREON BCise device here.

If you have questions about how to use BYDUREON BCise, you can speak to a nurse by calling 1-844-MY-BCISE (1-844-692-2473) (8 AM to 8 PM ET, Monday through Friday and 10 AM to 6 PM, Saturday and Sunday). You also can speak directly to a nurse through video chat who can demonstrate the injection technique and even watch as you perform your own injection. Click here for more details.*

*AstraZeneca cannot provide medical advice and can only provide information about AstraZeneca medications. Decisions regarding your health and treatment of your condition should be made with your own healthcare provider.

How should I store BYDUREON BCise?

BYDUREON BCise should be stored flat in the refrigerator between 36°F and 46°F (2°C to 8°C).

BYDUREON BCise can be kept at room temperature not to exceed 86°F (30°C) for up to 4 weeks, so you can take your weekly dose where it is most convenient for you.

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

Why should I store my devices flat in the refrigerator?

Devices stored vertically (with the needle up or down) are more difficult to mix. The medicine can still be fully mixed, but it will need to be shaken longer than the recommended 15 seconds.

How long can I keep the BYDUREON BCise device outside the refrigerator?

The device can be kept at room temperature not to exceed 86°F (30°C) for up to 4 weeks, so you can take your weekly dose where it is most convenient for you.

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

Where is the needle on the BYDUREON BCise device?

The needle is attached to the device and covered by the orange cap. When you unscrew the orange cap when taking BYDUREON BCise, a green shield pops up from the device to keep the needle covered until you inject.

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

How do I know if the medicine is fully mixed?

After shaking the device, look through both sides of the window. You should not see any white medicine along the bottom, top, or sides. If you see white medicine, it is unmixed. To mix, shake the device hard until the white medicine is no longer on the bottom, top, or sides. The medicine should look even throughout.

Why do I need to hold the device upright while removing the orange cap?

Holding the device with the orange cap straight up helps prevent the medicine from leaking. It is normal to see a few drops of medicine inside the orange cap after you unscrew it.

Why should I inject my medicine right away after mixing it?

If you do not inject your medicine right away after mixing, the medicine may separate, and you will not get your full dose. You can re-mix your medicine if your device is in the locked position. However, after you unlock it, you must complete the preparation steps right away and inject to get the full dose. You cannot save it for later use.

How do I know I gave myself the full dose of medicine?

To be sure you get your full dose, press and hold the device against your skin. You will feel the needle go into your skin. Hold the needle against your skin for 15 seconds. This will allow enough time for all the medicine to go from the autoinjector to under your skin. After removing the needle, look for the orange rod in the window as a way to tell that the dose has been given. If the orange rod does not appear, contact Customer Service at 1-877-700-7365.

What if I don’t have an FDA-cleared sharps container?

Do not throw away (dispose of) the device in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

  • Made of heavy-duty plastic

  • Can be closed with a tight-fitting, puncture-resistant lid, that won’t let sharps come out

  • Upright and stable during use

  • Leak-resistant

  • Properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and injection devices.

What if the device malfunctions and I cannot unlock it?

Review the Instructions for Use Step 3 to make sure you are following the right instructions, then contact Customer Service, 1-877-700-7365 for help as needed. Do not try to unlock with excessive force or tools.

What if the device malfunctions and I cannot remove the orange cap?

Review the Instructions for Use Step 3 to confirm the order of operations, also confirm that the knob is fully in the unlocked position, then call the Customer Service at 1-877-700-7365 for help as needed. Do not use tools or try to force the cap off.

Can I use my BYDUREON BCise device for more than one dose?

No, the device is not re-usable. After dosing once, place the entire device in an appropriate sharps container. Use a new device for each dose.

Support

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What support is available?

With BYDUREON BCise, you have easy access to a team that provides comprehensive support to help you get the most out of your treatment.

We can:

  • Provide information about our Savings Program for patients whose doctor has prescribed BYDUREON BCise to help manage their type 2 diabetes to help them get headed in a new direction

  • Connect you by phone or via video chat with a live nurse who can assist you with the injection process*

  • Connect you to counselors for answers regarding your prescription insurance coverage, including your co-pay

Simply call us at 1-844-MY-BCISE (1-844-692-2473). We’re available from 8 AM to 8 PM ET, Monday through Friday and 10 AM to 6 PM, Saturday and Sunday.

You can also register to receive important information, helpful tips, and dosing reminders via email and/or text message. Register here.

Visit the BYDUREON BCise Facebook page for news and information about BYDUREON BCise.

Find out more about BYDUREON BCise support services here.

*AstraZeneca cannot provide medical advice and can only provide information about AstraZeneca medications. Decisions regarding your health and treatment of your condition should be made with your own healthcare provider.

AstraZeneca does not file claims or appeals on behalf of patients or healthcare professionals. Coverage or co-pay amounts may change prior to the time of actual prescription fill.

Does BYDUREON BCise have a savings program?

Yes. With the BYDUREON Savings Program, you can pay as low as $0 every month* with your prescription for BYDUREON BCise.

*See eligibility requirements. Restrictions apply.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

BYDUREON BCise may cause serious side effects, 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 BCise will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people

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

  • Inflammation of the pancreas (pancreatitis) Stop using BYDUREON BCise 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 BCise with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Tell your healthcare provider if you take other diabetes medicines. Talk to your healthcare provider about managing low blood sugar. Signs and symptoms of low blood sugar include dizziness or lightheadedness, 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 stomach problems, such as slowed emptying of your stomach (gastroparesis) or problems digesting food. Other medicines like BYDUREON BCise may cause severe stomach problems. It is not known if BYDUREON BCise causes or worsens stomach problems

  • Serious allergic reactions Stop using BYDUREON BCise 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 BCise may include a bump at the injection site and/or nausea. Nausea is most common when you first start using BYDUREON BCise, 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 BCise, tell your healthcare provider if you are pregnant, nursing, or plan to become pregnant or nurse. BYDUREON BCise may harm your unborn baby.

APPROVED USES

  • BYDUREON BCise 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 BCise is not recommended as the first choice of medicine for treating diabetes

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

  • Do not use BYDUREON, BYDUREON BCise, BYETTA or other medicines containing exenatide together

  • It is not known if BYDUREON BCise can be used in people with a history of pancreatitis

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.