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.
Please click here for additional Important Safety Information.
BYDUREON (exenatide extended-release for injectable suspension) should be taken once every 7 days.
The most common side effects with BYDUREON include nausea, diarrhea, headache, vomiting, constipation, itching at injection site, a small bump (nodule) at the injection site, and indigestion. Nausea most commonly happens when first starting BYDUREON, but may become less over time.
You can choose to take your first dose on any day of the week. Then you’ll take it on the same day each week. This is your "dosing day." You can take BYDUREON at any time during your dosing day, with or without food.
Try to select a day and time that best fits into your weekly schedule and is easy to remember. It can help to choose a dosing day that is linked to a regular weekly activity. For example, if you have a favorite TV show you watch on Friday nights, you could plan to take your BYDUREON dose at that time.
If you want to change your dosing day, you can. When changing the dosing day, you can choose any day you want; however, the next dose must be taken at least 3 days after the previous dose. Do not take 2 doses of BYDUREON less than 3 days apart.
Example: How to change your dosing day from Friday to Sunday.
For example, let’s say you want to change your dosing day from Friday to Sunday. Take your BYDUREON on Friday, as scheduled. Because Sunday is less than 3 days from your original dosing day, you should take your next dose of BYDUREON on the following Sunday. (See calendar above.)
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.
If you miss taking BYDUREON on your dosing day, take 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 take your next dose on your regular dosing day. Don’t take 2 doses less than 3 days apart.
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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