Exenatide


Exenatide (marketed as Byetta)

FDA ALERT [10/2007]: FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases.

Healthcare professionals should instruct patients taking Byetta to seek prompt medical care if they experience unexplained persistent severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.

FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.

This is a summary of the most important information about Byetta. For details, talk to your health care professional.

What is Byetta?

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Byetta is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes. Byetta is used with metformin or another type of antidiabetic medicine called sulfonylureas. It may also be used with a combination of metformin and a sulfonylurea. There are many antidiabetic medicines that contain a sulfonylurea. Ask your healthcare professional or pharmacist if you are not sure if your antidiabetic medicine contains a sulfonylurea.
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Byetta is not a substitute for insulin in patients whose diabetes requires insulin treatment.
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Byetta has not been studied in children.

Who Should Not Use Byetta?

Do not use Byetta if you are allergic to exenatide or any of the other ingredients in Byetta.

What are The Risks?

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Byetta can cause low blood sugar (hypoglycemia) when used with a medicine that contains a sulfonylurea. The dose of your sulfonylurea medicine may need to be reduced while you use Byetta. The signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery. Your healthcare professional should tell you how to treat low blood sugar.
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The most common side effects include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is most common when first starting Byetta, but decreases over time in most patients.

What Should I Tell My Health Care Professional?

Before you start using Byetta, tell your health care professional if you:

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have severe problems with your stomach (gastroparesis) or food digestion.
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have severe kidney disease or you are on dialysis.
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are pregnant or planning to become pregnant.
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are breastfeeding.

Are There Any Interactions With Drugs or Foods?

Byetta can interact with other medicines. Know the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare professional and pharmacist.

Byetta slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Ask your healthcare professional if the time at which you take any of your oral medicines (for example, birth control pills, antibiotics) should be changed.

How Do I Use Byetta?

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See the Pen User Manual for instructions for using the Byetta Pen and injecting Byetta.
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Byetta comes in a prefilled pen. Each pen has 60 doses to provide 30 days of twiceâEUR”aâEUR”day injections. You must do a âEURoeNew Pen Set-UpâEUR (see User Manual) one time only, when starting a new prefilled Byetta Pen. If you do this âEURoeNew Pen Set-UpâEUR before each injection, you will run out of medicine before 30 days.
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Use Byetta exactly as prescribed by your healthcare professional. Your dose may be increased after using Byetta for 30 days. Do not change your dose unless your healthcare professional has told you to change your dose. Your healthcare professional must teach you how to inject Byetta before you use it for the first time.
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Pen needles are not included. Ask your healthcare professional which needle length and gauge is best for you.
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Inject your dose of Byetta under the skin (subcutaneous injection) of your upper leg (thigh), stomach area (abdomen), or upper arm.
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Byetta is injected, twice a day, at any time within the 60 minutes (1 hour) before your morning and evening meals. Do not take Byetta after your meal.
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If you miss a dose of Byetta, skip that dose and take your next dose at the next prescribed time. Do not take an extra dose or increase the amount of your next dose to make up for the one you missed.
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If you use too much Byetta, call your healthcare professional or poison control center right away. You may need medical treatment right away. Too much Byetta can cause nausea, vomiting, dizziness, or symptoms of low blood sugar.


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