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Safety
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.
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.
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
It has not been established that BYETTA causes pancreatitis. Some people taking
BYETTA have developed pancreatitis.
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 or insulin. You should know the symptoms of hypoglycemia
and how to 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.
- Before taking BYETTA, tell your healthcare provider if you have or have had
kidney problems, or have had a kidney transplant.
- BYETTA may cause new or worse problems with kidney function, including kidney
failure. Dialysis or kidney transplant may be needed.
- While taking BYETTA, call your healthcare provider right away if you have
nausea, vomiting, or diarrhea that will not go away, or if you cannot take liquids
by mouth. You may be at increased risk for kidney problems.
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.
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.
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 .
If you forget to take your diabetes pills, you should talk with your healthcare
provider about the proper use of BYETTA.
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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 can be used with Lantus® (insulin glargine), which is a long-acting insulin, but should not be taken with short- and/or rapid-acting 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 or insulin. The dose of your sulfonylurea or insulin 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, feeling jittery, dizziness, headache, acid stomach, constipation, and weakness. 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.
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