[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:
Information regarding post-market reports of acute renal failure and insufficiency, highlighting that exenatide should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.
Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of exenatide from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for exenatide if kidney dysfunction is suspected while using the product.
Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with exenatide.
For more information visit the FDA website at: [Web] and [Web].
REMS:
FDA approved a REMS for exenatide to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
EXENATIDE (ex EN a tide) is used to improve blood sugar control in adults with type 2 diabetes. This medicine is usually used with other oral diabetes medicines.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for injection under the skin of your upper leg, stomach area, or upper arm. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take it more often than directed.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
Some medications can hide the warning symptoms of low blood sugar (hypoglycemia). You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. To control your diabetes, you must use this medicine regularly and follow a diet and exercise schedule. Checking and recording your blood sugar and urine ketone levels regularly is important. Use a blood sugar measuring device before you treat high or low blood sugar.
Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure family members know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.
Wear a medical identification bracelet or chain to say you have diabetes, and carry a card that lists all your medications.
Many nonprescription cough and cold products contain sugar or alcohol. These can affect diabetes control or can alter the results of tests used to monitor blood sugar. Avoid alcohol. Avoid products that contain alcohol or sugar.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store unopened pen in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or use if the medicine has been frozen. Protect from light and excessive heat. After you first use the pen, it should be kept at a temperature not to exceed 25 degrees C (77 degrees F). Throw away your used pen after 30 days or after the expiration date, whichever comes first.
Do not store your pen with the needle attached. If the needle is left on, medicine may leak from the pen or air bubbles may form in the cartridge.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
