IMPORTANT SAFETY INFORMATION for BYETTA® (exenatide) injection
- Do not take 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. Symptoms of a severe allergic reaction include severe rash or itching, swelling of your face, lips, and throat that may cause difficulty breathing or swallowing, feeling faint or dizzy and very rapid heartbeat. If you have any symptoms of a severe allergic reaction, stop taking BYETTA and get medical help right away.
- Inflammation of the pancreas (pancreatitis) may happen, 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. Stop taking BYETTA 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 abdomen through to your back. These may be symptoms of pancreatitis.
- Your risk for getting low blood sugar (hypoglycemia) 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. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.
- Tell your healthcare provider if you have or had kidney problems or a kidney transplant. BYETTA may cause new or worse problems with the way your kidneys work. 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.
- 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.
- 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.
- Before using BYETTA, tell your doctor about all the medicines you take, as taking them with BYETTA may affect how each medicine works. Tell your healthcare provider if you take other diabetes medicines, especially insulin or a sulfonylurea, or birth control pills, an antibiotic, warfarin sodium (Coumadin® or Jantoven®), a blood pressure medicine, water pill, pain medicine, or lovastatin (Altoprev®, Mevacor®, or Advicor®). Take your birth control pills or antibiotics at least one hour before injecting BYETTA.
- 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.
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.
WHAT IS BYETTA?
BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise. 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 should not be used in people with type 1 diabetes or people with diabetic ketoacidosis (a condition caused by very high blood sugar). BYETTA is not recommended for use in children. BYETTA has not been studied in people who have pancreatitis. BYETTA should not be used in people who have severe kidney problems.
Please click here for Medication Guide and click here for US Full Prescribing Information for BYETTA (exenatide) injection.