IMPORTANT SAFETY INFORMATION for BYDUREON® (exenatide extended-release) for injectable suspension
IMPORTANT SAFETY INFORMATION
POSSIBLE THYROID TUMORS, INCLUDING CANCER: 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. In animal studies, BYDUREON and medicines that work like it caused thyroid tumors, including thyroid cancer. It is not known if BYDUREON will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use BYDUREON if you or any of your family members have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Do not use BYDUREON if you have had an allergic reaction to exenatide or any of the other
ingredients in BYDUREON.
BYDUREON may cause serious side effects, including:
Inflammation of the pancreas (pancreatitis). Stop using BYDUREON and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or lightheadedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery
Kidney problems (kidney failure). Tell your healthcare provider if you have or had kidney problems. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse
Stomach problems. Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems digesting food. Other medicines like BYDUREON may cause severe stomach problems. It is not known if BYDUREON causes or worsens stomach problems
Serious allergic reactions. Stop using BYDUREON and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing
Injection-site reactions. Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use BYDUREON. Some of these injection-site reactions have required surgery. Call your healthcare provider if you have any symptoms of injection-site reactions, including severe pain, swelling, blisters, an open wound, or a dark scab
The most common side effects with BYDUREON may include nausea, diarrhea, headache, vomiting, constipation, itching at the injection site, a small bump (nodule) at the injection site, and indigestion. Nausea is most common when you first start using BYDUREON, but decreases over time in most people as their body gets used to the medicine.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as taking them with BYDUREON may affect how each medicine works.
Before using BYDUREON, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other diabetes medicines, including insulin or sulfonylureas.
Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYDUREON will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.
APPROVED USES for BYDUREON
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 choice of medicine for treating diabetes.
BYDUREON is not a substitute for insulin and is not for people with type 1 diabetes or people with diabetic ketoacidosis.
BYDUREON is a long-acting form of the medication in BYETTA® (exenatide) injection so both drugs should not be used at the same time.
It is not known if BYDUREON can be used in people with a history of pancreatitis or if BYDUREON is safe and effective for use in children.
Please click here for Medication Guide, and click here for Full Prescribing Information for BYDUREON 2 mg, including Boxed WARNING about possible thyroid tumors including thyroid cancer.