Important Safety Information
Prescribing Information
Medication Guide
Select Safety Information
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Outdated term for type 2 diabetes.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.
Text size
Indication

5-mcg Dose
10-mcg Dose
10-mcg Dose

Pen Tutorial

Safety and Storage

What is the most common side effect with use of BYETTA?

The most common side effect with BYETTA is mild-to-moderate nausea, which decreases over time in most patients. Fewer than half of the patients in clinical studies experienced nausea.

What do I need to know about hypoglycemia with BYETTA?

Your risk for getting hypoglycemia (low blood sugar) is higher if you take BYETTA with another medicine that can cause hypoglycemia, such as a sulfonylurea. You should know the symptoms of hypoglycemia and how to manage them.

What are the symptoms of hypoglycemia and how do I manage them?

Ask your healthcare provider for a list of what you can use to treat hypoglycemia. Be sure you always have at least one type of these items with you. If you develop hypoglycemia, act quickly. Check your blood sugar (glucose) and treat your hypoglycemia with one of the items from the list in the table below. Wait 15 to 20 minutes and check your blood sugar again. If your blood sugar is still low and your symptoms of hypoglycemia don't go away, repeat this treatment. After you feel better, be sure to eat your regular meals and snacks as planned to keep your blood sugar from going too low.


Does BYETTA interact with any other medicines I take?

BYETTA can slow down how quickly some medicines taken by mouth get into the bloodstream. For medications that need to be absorbed quickly, like birth control pills or antibiotics, you should take those medicines at least 60 minutes before injecting BYETTA. Make sure your doctor and pharmacist know all the medicines you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements. Ask your pharmacist to help you determine the best times to take your medications.

What if I took or am taking BYETTA while pregnant?

If you are pregnant or planning to become pregnant, you should tell your healthcare provider. It is not known if BYETTA may harm your unborn child. Amylin Pharmaceuticals, Inc. has a registry for women who have taken BYETTA during pregnancy. The purpose of this registry is to collect information about the results of the pregnancy and the health of the child. If you took BYETTA at any time during pregnancy you are encouraged to enroll in the Pregnancy Registry by calling (800) 633-9081, or you can learn more by visiting ExenatidePregnancyRegistry.com.

If I am taking diabetes pills and I forget to take them, should I still take my BYETTA?

If you forget to take your diabetes pills, you should talk with your healthcare provider about the proper use of BYETTA.

What should I do if I'm dining out?

Since you can eat up to an hour after taking your BYETTA injection, you could take your injection at home and then leave for the restaurant. Just make sure you start eating within an hour after taking your BYETTA. So if you take the injection at home at 5:00 pm, you need to start eating at the restaurant anytime before 6:00 pm. You can also take BYETTA with you and give yourself an injection at the restaurant.

How should I store my BYETTA Pen?

How do I store my BYETTA Pen when I am traveling?

After first use, your BYETTA Pen can be kept at a room temperature not to exceed 77°F (25°C). Do not freeze. Do not use BYETTA if it has been frozen. BYETTA should be protected from light.

How do I travel with BYETTA by plane?

Your pen should not be put in your checked baggage but should be kept with you at all times. Due to the frequent changes in airport security, you should contact the Transportation Security Administration (1-866-289-9673 or www.tsa.gov), your airline, or airport for the latest information on carry-on restrictions.

How long can I use my BYETTA Pen?

You can use your BYETTA Pen for up to 30 days after setting up a new pen for first use. After 30 days, throw away the BYETTA Pen, even if it is not completely empty. Mark the date when you first used your pen and the date 30 days later. BYETTA should not be used after the expiration date printed on the pen label.

What is pancreatitis?

Pancreatitis is inflammation of the pancreas. The pancreas releases enzymes to help your body digest food and releases hormones, such as insulin, which help regulate your blood sugar.

What are the symptoms of pancreatitis?

Symptoms of pancreatitis include severe and persistent abdominal pain with or without vomiting. The pain may be felt going from your abdomen through to your back. If you experience severe and persistent abdominal pain you should seek medical care and inform your healthcare provider.

What can cause pancreatitis?

Pancreatitis may be caused by many factors, including gallstones, heavy alcohol use, elevated blood levels of calcium or triglycerides (fat), injury to the abdomen, infection, and some medications. Patients with type 2 diabetes also appear to be at greater risk of developing pancreatitis than the general population (without diabetes).1

1. Noel RA, Braun DK, Patterson RE, Bloomgren G. Increased Risk of Acute Pancreatitis Observed in Patients with Type 2 Diabetes [409-Poster ISPE 2008]

Does BYETTA cause pancreatitis?

It has not been established that BYETTA causes pancreatitis. Some people taking BYETTA have developed pancreatitis.

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.