Important Safety Information for BYETTA^® injection

Important Safety Information for BYETTA^® injection

• Do not take BYETTA if you have had an allergic reaction to exenatide or any of the other ingredients in BYETTA.

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  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.
• Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
• 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. Stop using BYETTA 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.
• 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; hunger; fast heart beat; dizziness; confusion; anxiety, irritability, or mood change; sweating; feeling jittery; blurred vision; slurred speech.
• Tell your healthcare provider if you have or have 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. Other medicines like BYETTA may cause severe stomach problems. It is not known if BYETTA will cause or worsen stomach problems.
• The most common side effects with BYETTA include nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, indigestion, constipation, and weakness. Nausea is most common when first starting BYETTA, but may decrease over time.
• Before using BYETTA, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, 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.
• Before using BYETTA, tell your healthcare provider if you are pregnant, nursing, or plan to become pregnant or nurse. BYETTA may harm your unborn baby.

Approved Uses

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 is not a substitute for 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).
• It is not known if BYETTA can be used in people with a history of pancreatitis.
• BYETTA should not be used in people who have severe kidney problems.

Approved Uses

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 is not a substitute for 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).
• It is not known if BYETTA can be used in people with a history of pancreatitis.
• BYETTA should not be used in people who have severe kidney problems.

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Please see full Prescribing Information and Medication Guide for BYETTA^® (exenatide) injection 5 mcg and 10 mcg.