Special Alerts:
[Posted 10/16/2007] FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking exenatide (Byetta), a drug used to treat adults with type 2 diabetes. An association between exenatide and acute pancreatitis is suspected in some of these cases. Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.
Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking exenatide 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, exenatide should be discontinued. If pancreatitis is confirmed, exenatide should not be restarted unless an alternative etiology is identified. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Byetta and http://www.fda.gov/cder/drug/infopage/exenatide/default.htm.
You must use this medication within 60 minutes (1 hour) before eating a meal. If you miss a dose, use the medication as soon as you remember, but only if you have not yet eaten a meal. If you have already eaten a meal, wait until your next scheduled dose (1 hour before a meal) to use the medicine. Do not use exenatide after eating a meal.
It is important to use exenatide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
To be sure this medication is helping your condition, you will need to check your blood sugar at home. Your blood will also need to be tested by your doctor on a regular basis. Do not miss any scheduled appointments.
Use the exenatide pen for only 30 days and then throw it away, even if it still has medicine in it. Do not use the medicine after the expiration date on the label has passed.
Before using exenatide, tell your doctor if you use any of these oral diabetes medications: acetohexamide (Dymelor), chlorpropamide (Diabinese), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (DiaBeta), tolazamide (Tolinase), tolbutamide (Orinase).
If you are using any type of antibiotic or birth control pill, take these medicines at least 1 hour before you use exenatide.
Exenatide is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently.
Exenatide is used to treat type 2 (non-insulin dependent) diabetes. Other diabetes medicines are sometimes used in combination with exenatide if needed.
Exenatide may also be used for purposes other than those listed in this medication guide.
Before taking exenatide, tell your doctor if you have:
problems with digestion; or
severe stomach disorders (gastroparesis).
If you have any of these conditions, you may need a dose adjustment or special tests to safely use exenatide.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or if you become pregnant during treatment. It is not known whether exenatide passes into breast milk or if it could be harmful to a nursing baby. Do not take exenatide without telling your doctor if you are breast-feeding a baby.![]() |
![]() |
