Important Safety Information
Prescribing Information
Medication Guide
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Glossary
A1C
A blood test that measures average blood sugar (glucose) over the past 2 to 3 months.
Glossary
Adult-Onset Diabetes
Outdated term for type 2 diabetes.
Glossary
Alpha Cells
A type of cell in the pancreas that makes and releases a hormone called glucagon.
Glossary
Beta Cells
Cells in the pancreas that make insulin.
Glossary
Blood Sugar
Glucose (sugar) found in the blood and the body's main source of energy. Also called blood glucose.
Glossary
Blood Sugar Level
The amount of glucose (sugar) in a given amount of blood. It is reported as the number of milligrams of glucose in a deciliter of blood, or mg/dL.
Glossary
Blood Sugar Meter
A hand-held machine that tests blood sugar (glucose) levels. A drop of blood, obtained by pricking a finger, is placed on a small strip that is inserted in the meter which measures and displays the blood sugar level.
Glossary
Blood Sugar Monitoring
Checking blood sugar (glucose) levels on a regular basis in order to manage diabetes. A blood sugar meter is needed for frequent blood sugar monitoring.
Glossary
Carbohydrate
One of the three main nutrients in food. Foods that provide carbohydrate include starches, breads, vegetables, fruits, milk products, and sugars.
Glossary
Certified Diabetes Educator (CDE)
A healthcare provider with expertise in diabetes education who has met eligibility requirements and successfully completed a certification exam.
Glossary
Diabetic Ketoacidosis (DKA)
An emergency condition in which extremely high blood sugar levels, along with a severe lack of insulin, result in the breakdown of body fat for energy and an accumulation of ketones in the blood and urine. DKA can cause nausea and vomiting, stomach pain, fruity breath odor, and rapid breathing. Untreated DKA can lead to coma and death.
Glossary
Dose
The amount of a medicine to be taken within a given period.
Glossary
Fat
One of the three main nutrients in food. Foods that provide fat include butter, margarine, salad dressing, oil, nuts, meat, poultry, fish, and some dairy products. Excess calories are stored as body fat, providing the body with a reserve supply of energy.
Glossary
Fixed Dose
A specific, unchanging amount of a medicine.
Glossary
Glucagon
A hormone produced by the alpha cells in the pancreas. Glucagon raises blood sugar (glucose) by releasing glucose from the liver. Glucagon is also available as an injectable drug for the treatment of severe hypoglycemia (low blood sugar).
Glossary
Glucose
The sugar that the body makes from the three elements of food — proteins, fats, and carbohydrates — but mostly from carbohydrates. Glucose is the major source of energy for living cells. Because glucose is carried to each cell through the bloodstream, it is often called "blood glucose" or "blood sugar."
Glossary
Hyperglycemia
Also called high blood sugar. Hyperglycemia can happen when the body does not have enough insulin or when the body can't use insulin properly. Symptoms may include excessive thirst, frequent urination, dry skin, blurred vision, and fatigue.
Glossary
Hypoglycemia
Also called low blood sugar (glucose). Symptoms may include sweating, trembling, hunger, dizziness, moodiness, confusion, and blurred vision.
Glossary
Incretin Mimetic
A class of type 2 diabetes drugs that "mimic" the effects of naturally occurring hormones from the intestines and can help the body make more of its own insulin.
Glossary
Insulin
A hormone produced in the pancreas by beta cells, which is necessary for glucose (sugar) to be able to enter certain cells of the body and be used for energy.
Glossary
Insulin-Dependent Diabetes Mellitus (IDDM)
Outdated term for type 1 diabetes.
Glossary
Insulin Resistance
The body's inability to respond to and use the insulin it produces. Insulin resistance may be linked to obesity, hypertension, and high levels of fat in the blood.
Glossary
Ketones
Chemical substances that are made by the body when fat is used as a fuel source instead of glucose. When ketones build up to a great extent in the body, serious illness or coma can result.
Glossary
Liver
A large organ in the body that has many functions, including the production and storage of glucose (sugar).
Glossary
Non-Insulin–Dependent Diabetes Mellitus (NIDDM)
Outdated term for type 2 diabetes.
Glossary
Metformin
The generic name for an oral anti-diabetic medicine (brand name: Glucophage®) that works by decreasing the amount of glucose that your liver makes on its own. It also works by making the cells in your body more sensitive to the insulin in your body.
Glossary
Pancreas
An organ located behind the lower part of the stomach that produces the hormones insulin and glucagon, and releases them into the bloodstream to help control blood sugar (glucose) levels. The pancreas also produces digestive enzymes.
Glossary
Protein
One of the three main nutrients in food. Foods that provide protein include meat, poultry, fish, cheese, milk, dairy products, eggs, and dried beans. Proteins are also used in the body to build cells, to create insulin and other hormones, and other functions.
Glossary
Sharps Container
A container for disposal of used needles and syringes; often made of hard plastic so that needles cannot poke through.
Glossary
Sulfonylurea
A class of oral medicine for type 2 diabetes that lowers blood sugar (glucose) by helping the pancreas to make more insulin. Examples include Amaryl® (glimepiride), Glucotrol® (glipizide), and Micronase® (glyburide).
Glossary
Thiazolidinedione
A class of oral medicine for type 2 diabetes that lowers blood sugar (glucose) by helping the pancreas to make more insulin. Examples include Amaryl® (glimepiride), Glucotrol® (glipizide), and Micronase® (glyburide).
Glossary
Type 1 Diabetes
A condition characterized by high blood sugar (glucose) levels caused by a lack of insulin production. Type 1 diabetes occurs when the body's immune system destroys the cells in the pancreas that produce insulin. The pancreas then produces little or no insulin. Type 1 diabetes develops most often in young people but can appear in adults and affects 10% of people living with diabetes. People with type 1 diabetes must take insulin daily to sustain life.
Glossary
Type 2 Diabetes
A condition characterized by high blood sugar (glucose) levels caused by either a lack of insulin or the body's inability to use insulin efficiently. Type 2 diabetes develops most often in middle-aged and older adults but can appear in young people, and is the most common form of diabetes.
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Pen Tutorial


Get answers to the most frequently asked questions about BYETTA by choosing a topic below:




BYETTA Basics

Why would my doctor prescribe BYETTA?

Despite your best efforts, type 2 diabetes can progress over time. If you are no longer able to effectively control your blood sugar (glucose), your doctor may decide to prescribe BYETTA.

BYETTA may give your body the extra help it needs to get your blood sugar under control by working in a different way than pills or insulin. BYETTA works in at least four different ways to help you take better control of your type 2 diabetes.

Is BYETTA approved for use as a stand-alone medication?

Yes. BYETTA is approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Previously, it was approved for use only in patients who were also taking other common diabetes medications and had not achieved adequate blood sugar control.

How can BYETTA help me?

BYETTA helps control your blood sugar in at least four different ways:

Through these ways, BYETTA can help improve both your blood sugar levels after meals and your overall blood sugar levels.

With the news about Avandia® (rosiglitazone), I'm concerned about taking it. Can I take BYETTA instead?

Patients should not stop taking any prescribed medications without first discussing the issue with their healthcare provider. Patients who are taking Avandia should talk to their healthcare provider to determine the most appropriate course of action.

BYETTA and Avandia are very different medicines, in two different classes, and work in completely different ways. BYETTA is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes, when used with a diet and exercise program. It can also be used with metformin (Glucophage®); a sulfonylurea like Amaryl® (glimepiride), Glucotrol® (glipizide), and Micronase® (glyburide); or a thiazolidinedione, including Avandia or Actos® (pioglitazone).

BYETTA works in several ways to help you get improved control of your blood sugar and allows most people to lose weight. To find out if BYETTA may be right for you, click here to take a personal assessment. You can print the results and discuss them with your healthcare provider.

How do I take BYETTA?

BYETTA comes in a prefilled injection pen which uses a very small needle. And since the pen device contains pre-measured doses, you don't have to adjust the dose in that pen.

You should inject BYETTA twice daily — once before your morning and evening meals (or before the two main meals of the day, at least 6 hours apart). After each injection, you should eat your meal anytime during the following 60 minutes. To view an interactive tutorial that demonstrates how to use the BYETTA Pen, click here. If you are new to BYETTA and still have questions following review of the tutorial and Frequently Asked Questions, you can also speak with a BYETTA specialist about using the BYETTA Pen by calling 1-800-868-1190.

Will I ever need to change doses?

Your healthcare provider should start you off with a dose of 5 micrograms (mcg) twice a day for at least 30 days, but may decide to increase your dose to 10 mcg based on your individual results.

Is BYETTA like insulin?

Even though it is an injection, BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not recommended to be taken with insulin. BYETTA actually helps your body make more of its own insulin.

How long does it take for BYETTA to begin lowering blood sugar?

Research has shown that BYETTA starts working as soon as the very first dose. So you can see better control of your blood sugar levels on the first day. As you continue to take BYETTA, you should see overall improvements in your A1C (a 3-month average of your blood sugar levels).

Will BYETTA affect my weight?

Patients taking BYETTA may feel less hungry and eat less. In clinical trials, on average, people taking BYETTA with certain diabetes pills lost 5 pounds in 30 weeks, and people taking BYETTA alone lost 8 pounds in 26 weeks (BYETTA is not a weight-loss product).* Some medicines for type 2 diabetes, such as sulfonylureas and insulin, can cause weight gain, while other drugs, such as metformin, do not usually affect weight.

*Compared with those not on BYETTA. Results with 10-mcg dose.

Do I need to do extra blood sugar monitoring while on BYETTA?

You do not need to do extra blood sugar monitoring while on BYETTA. However, self-monitoring of blood sugar is important and will help you and your healthcare provider determine how well your diabetes is controlled. Blood sugar could be checked 2 hours after the start of a meal to see how well BYETTA is working.

Where should my blood sugar levels be?

The American Diabetes Association has guidelines that help you set goals for your blood sugar. Having better control of your blood sugar can have a positive effect on your overall health. Many studies show that the closer you are to these goals, the better chance you have of avoiding complications with your health. Talk with your healthcare provider about what blood sugar levels are right for you.


Is BYETTA covered by insurance?

Coverage for BYETTA varies by insurance plan. Your healthcare provider can contact the Amylin/Lilly Reimbursement Hotline for assistance in verifying insurance coverage or in researching alternative sources of coverage.

Where can I find additional information on the Medicare drug program?

Information on the Medicare drug benefit is available by calling toll-free 1-800-MEDICARE (1-800-633-4227) or by visiting www.medicare.gov.

Is there a patient assistance program if I don't have insurance?

Amylin and Lilly are committed to assisting patients with diabetes in accessing coverage for its product(s). The Patient Assistance Program is available for patients prescribed BYETTA who do not have adequate insurance and/or do not have any other financial assistance and meet the eligibility criteria. In order to be considered for the Patient Assistance Program, patients will need to complete an application form and provide information on financial status.

How do I find out more about BYETTA?

More information on BYETTA is available by calling the Amylin/Lilly Customer Support Center toll-free at 1-800-868-1190. Your doctor, pharmacist, or other healthcare provider can also help you find more information on BYETTA.

How do I contact a diabetes educator?

A diabetes educator can be found in your area by calling the American Association of Diabetes Educators (AADE) at 1-800-TEAMUP4 (1-800-832-6874) or by going online at www.diabeteseducator.org.

Indication

BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program.

BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.

Important Safety Information for BYETTA® (exenatide) injection

  • Serious side effects can happen in people who take BYETTA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking BYETTA, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. 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 and may be felt going from your abdomen through to your back.
  • Your risk for getting low blood sugar is higher if you take BYETTA 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 BYETTA.
  • BYETTA should not be used in people who have severe kidney problems and should be used with caution in people who have had a kidney transplant. BYETTA may cause new or worse problems with kidney function, including kidney failure.
  • Before you use BYETTA, 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.
  • Do not use BYETTA if you have had an allergic reaction to exenatide or any of the other ingredients in BYETTA. Severe allergic reactions can happen with BYETTA. Stop taking BYETTA and get medical help right away.
  • Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYETTA will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.
  • The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly happens when first starting BYETTA, but may become less over time.

Indication

BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program.

BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.

Important Safety Information for BYETTA® (exenatide) injection

  • Serious side effects can happen in people who take BYETTA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking BYETTA, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. 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 and may be felt going from your abdomen through to your back.
  • Your risk for getting low blood sugar is higher if you take BYETTA 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 BYETTA.
  • BYETTA should not be used in people who have severe kidney problems and should be used with caution in people who have had a kidney transplant. BYETTA may cause new or worse problems with kidney function, including kidney failure.
  • Before you use BYETTA, 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.
  • Do not use BYETTA if you have had an allergic reaction to exenatide or any of the other ingredients in BYETTA. Severe allergic reactions can happen with BYETTA. Stop taking BYETTA and get medical help right away.
  • Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYETTA will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.
  • The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly happens when first starting BYETTA, but may become less over time.

These are not all the side effects with BYETTA. Talk to your healthcare provider about any side effect that bothers you or that does not go away.

Please see the BYETTA Prescribing Information and Medication Guide.