IMPORTANT SAFETY INFORMATION: POSSIBLE THYROID TUMORS, INCLUDING CANCER:
In animal studies, BYDUREON caused rats to develop tumors of the thyroid gland. Some of these tumors were cancer. It is not known if BYDUREON causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. Do not take BYDUREON if you or any of your family members have MTC or if you have Multiple Endocrine Neoplasia syndrome type 2. While taking BYDUREON, 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.
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Taken just once a week, BYDUREON (exenatide extended-release for injectable suspension) is continuously released throughout the week, working with your body to help manage your blood sugar levels.
Once-weekly BYDUREON works with your body in the following ways:
Inflammation of the pancreas (pancreatitis) may happen, which may be severe and lead to death. Before taking BYDUREON, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. Stop taking BYDUREON and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away, occurs with or without vomiting, or is felt going from your stomach area through to your back. These may be symptoms of pancreatitis.
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 medication to treat diabetes.
BYDUREON is a long-acting form of the medication in BYETTA® (exenatide) injection so both drugs should not be used together. BYDUREON is not a substitute for insulin and has not been studied in combination with insulin. BYDUREON is not for people with type 1 diabetes or people with diabetic ketoacidosis (a condition caused by very high blood sugar). BYDUREON is not recommended for use in children. It is not known if BYDUREON is safe and effective in people with a history of pancreatitis or severe kidney problems.
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.
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