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| Other drug names: | A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 |
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[Posted 11/02/2009] FDA notified healthcare professionals of revisions to the prescribing information for exenatide (Byetta) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Exenatide, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using exenatide. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Labeling changes include:
[UPDATED 08/18/2008] Since issuing Information for Healthcare Professionals (http://www.fda.gov/Drugs) in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases. Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch, http://www.fda.gov/Safety/MedWatch and http://www.fda.gov/Safety/MedWatch. |
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Exenatide is used in combination with metformin, a sulfonylurea, or a thiazolidinedione medication to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Exenatide is in a class of medications called incretin mimetics. It works by stimulating the pancreas to secrete insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Exenatide also slows the emptying of the stomach and causes a decrease in appetite. Exenatide is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). Exenatide is not used instead of insulin to treat people with diabetes who need insulin.
Exenatide comes as a solution (liquid) in a prefilled dosing pen to inject subcutaneously (under the skin). It is usually injected twice a day within 60 minutes before the morning and evening meals. Exenatide should not be injected after meals. Your doctor will probably start you on a low dose of exenatide and may switch you to a pen with a higher dose of medication if your blood sugar control has not improved after you have used exenatide for 1 month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use exenatide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Exenatide controls diabetes but does not cure it. Continue to use exenatide even if you feel well. Do not stop using exenatide without talking to your doctor.
Exenatide comes in prefilled dosing pens that contain enough medication for 60 doses (two doses a day for 1 month). You will need to buy needles separately. Ask your doctor or pharmacist what type of needles you will need to inject your medication. Be sure to read and understand the manufacturer's instructions for injecting exenatide using the pen. Also make sure you know how and when to set up a new pen. Ask your doctor or pharmacist to show you how to use the pen. Follow the directions carefully. Never remove the cartridge from the pen or attempt to add any other type of medication to the cartridge.
Always look at your exenatide solution before you inject it. It should be as clear, colorless, and fluid as water. Do not use exenatide if it is colored, cloudy, thickened, or contains solid particles, or if the expiration date on the bottle has passed.
Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Throw away needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture resistant container.
Exenatide can be administered in the thigh (upper leg), abdomen (stomach), or upper arm. Use a different site for each injection, about 1 inch (2.5 centimeters) away from the previous injection but in the same general area (for example, the thigh). Use all available sites in the same general area before switching to a different area (for example, the upper arm). Do not use the same injection site more often than once every month.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Before using exenatide injection,
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet.
Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using exenatide.
Skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.
You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:
If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.
Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar) :
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of the these symptoms:
Exenatide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
Exenatide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Store unused exenatide pens in their original carton in the refrigerator protected from light. Once in use, store exenatide pens at room temperature (up to 77 °F [25 °C]) protected from light. Do not freeze. Do not use exenatide if it has been frozen. Do not store exenatide pens with the needle attached. Keep exenatide pens out of the reach of children.
When traveling, be sure to keep exenatide pens dry. Unused pens should be refrigerated or at a cold temperature between 36 to 46 °F (2 to 8 °C). Pens that are in use can be stored at room temperature up to 77 °F (25 °C) (not in a car glove compartment or other hot place).
Make a note of the date you first use an exenatide pen, and throw away the pen after 30 days, even if there is some solution left in the pen. Throw away any exenatide pens that are outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to exenatide. Your doctor will also tell you how to check your response to this medication by measuring your blood or urine sugar levels at home. Follow these instructions carefully.
See your dentist twice yearly; see your eye doctor regularly; get your blood pressure checked regularly.
Keep yourself and your clothes clean. Wash cuts, scrapes, and other wounds quickly, and do not let them get infected. Wear medical alert identification (a bracelet or tag) that says you have diabetes.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Last Revised - 11/01/2009
AHFS® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
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Page last updated: 18 November 2009 |