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Exenatide Solution for injection

It is used to improve blood sugar control in adults with type 2 diabetes

Generic Name: exenatide  |  Brand Name: Bydureon

Brand Names: Byetta, Bydureon

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[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 However, FDA later rescinded REMS requirements.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]).

What is this medicine?

EXENATIDE (ex EN a tide) is used to improve blood sugar control in adults with type 2 diabetes. This medicine may be used with other oral diabetes medicines.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • history of pancreatitis
  • kidney disease or if you are on dialysis
  • stomach problems
  • an unusual or allergic reaction to exenatide, medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

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 special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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:
  • gatifloxacin

This medicine may also interact with the following medications:

  • acetaminophen
  • birth control pills
  • digoxin
  • lisinopril
  • lovastatin
  • sulfonylureas
  • warfarin

Many medications may cause changes in blood sugar, these include:

  • alcohol containing beverages
  • aspirin and aspirin-like drugs
  • chloramphenicol
  • chromium
  • diuretics
  • female hormones, such as estrogens or progestins, birth control pills
  • heart medicines
  • isoniazid
  • male hormones or anabolic steroids
  • medications for weight loss
  • medicines for allergies, asthma, cold, or cough
  • medicines for mental problems
  • medicines called MAO inhibitors - Nardil, Parnate, Marplan, Eldepryl
  • niacin
  • NSAIDS, such as ibuprofen
  • pentamidine
  • phenytoin
  • probenecid
  • quinolone antibiotics such as ciprofloxacin, levofloxacin, ofloxacin
  • some herbal dietary supplements
  • steroid medicines such as prednisone or cortisone
  • thyroid hormones

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:

  • beta-blockers, often used for high blood pressure or heart problems (examples include atenolol, metoprolol, propranolol)
  • clonidine
  • guanethidine
  • reserpine


Last Updated: February 03, 2012
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