What to Know About Bydureon (Exenatide)

Diabetes is a progressive disease, meaning that if you've had diabetes for several years and are noticing that your blood sugar control is worsening while still using oral medication as directed, you may need to consider another alternative.

Sometimes adjustments in medication regimens need to be made to help manage blood sugar. Often, people with diabetes can benefit from using an injectable medication (other than insulin) in addition to their pill medications. Non-insulin injectable medicines referred to as glucagon-like peptide-1 receptor agonists (GLP-1 RA) such as Bydureon, Byetta and Victoza, have been shown to help lower after-meal blood sugar and reduce weight.

Bydureon is a long-acting GLP-1 RA, which stimulates insulin secretion when it comes into contact with glucose. The medication is unique from competitors in its class in that it is only dosed once a week via injection, as opposed to once or twice daily, as with Victoza and Byetta.

Bydureon has also been shown to preserve the function of beta cells—the cells responsible for making insulin in the pancreas—and has been proven to promote weight loss by delaying gastric (stomach) emptying and increasing feelings of fullness. Studies have shown that people taking Bydureon drop an average of five pounds by month six of taking the medication and have been shown to sustain the weight loss by year three.

New research by the makers of Bydureon, AstraZeneca, demonstrates that the once-weekly injection of exenatide led to greater average reductions in hemoglobin A1c (around 1.5 percent) than Byetta, a twice-daily injection of exenatide. Patients in both the Bydureon and Byetta groups had similar reductions in average body weight (about 3.3 pounds lost while taking Bydureon and about 4.2 pounds lost while taking Byetta).

Other studies have shown that when compared to insulin, patients using Bydureon often lose more weight–which is also helpful in the long-term management of blood sugar. 

Off-Label Uses

Bydureon is often shown to be helpful for weight loss, but it is not specifically approved as a weight-loss drug. Bydureon should be used in combination with a healthy diet and exercise.

Bydureon is also not a substitute for insulin and should not be used in place of insulin for people with type 1 diabetes or diabetic ketoacidosis. According to the manufacturer, Bydureon has not been studied for use in conjunction with insulin.

Discuss with your healthcare provider if you are a candidate for Bydureon. While clinical trials have shown that treatment with Bydureon can help to reduce A1c by about 1.5 percent, Bydureon is not typically used as a first-line diabetes treatment. Instead, it is most often used as a second or third agent in combination with other diabetes medicines such as metformin or a sulfonylurea.

If you are taking a sulfonylurea, your dose may need to be adjusted to reduce the risk of hypoglycemia.

Precautions and Contraindications

In animal studies, Bydureon caused rats to develop tumors of the thyroid gland. Therefore, Bydureon is contraindicated in patients with a personal or family history of medullary thyroid cancer (MTC) and in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). People with a sensitivity to exenatide or to any product components should also not take Bydureon.

Before taking Bydureon, tell your provider if you have a history of gastrointestinal disease, pancreatitis, gallstones, a history of alcoholism, or high blood triglyceride levels, as Bydureon may not be meant for you. When taking Bydureon, if you experience severe stomach pain that does not go away, you should contact your healthcare provider immediately as this may be a sign of pancreatitis or gastroparesis.

Bydureon is not intended for patients with type 1 diabetes. 

Bydureon should only be used in pregnancy if the potential benefits of use outweigh the potential risks to the fetus.

Bydureon has not been studied in pediatric patients and should not be taken by children or teens.

Other GLP-1 RA drugs similar to Bydureon include:

• Trulicity (dulaglutide)
• Bydureon BCise, Byetta (exenatide)
• Victoza (liraglutide)
• Adlyxin (lixisenatide)
• Ozempic (semaglutide)

According to the manufacturer, the standard dosage for those with type 2 diabetes is one 2 milligram injection every seven days, on the same day each week. Bydureon can be taken at any time of day, with or without food.

Bydureon is available in the following forms:

• Single-dose tray containing 2 mg of exenatide in a single-dose vial
• Single-dose pen containing 2 mg of exenatide

All dosages are according to the drug manufacturer. Check your prescription and talk to your doctor to make sure you are taking the right dose for you.

How to Take and Store

Bydureon is available for use via syringe or injectable pen. The pen may be more comfortable and easier to use than a standard syringe. 

Before dosing with the pen form, the medication must be brought to room temperature for 15 minutes and evenly mixed by shaking the device vigorously up and down for at least 15 seconds with the orange cap pointing up. Follow the complete instructions in the Instructions for Use section of the medication information.

Bydureon should be injected subcutaneously into fatty tissue and not into a muscle or vein. You can inject Bydureon in the same places you would insulin—your abdomen (two inches below your belly button), outer thighs, or the backs of your upper arms. You can use the same area weekly, just try not to use the same exact location. To ensure you get the full dose, make sure you hold the pen at the injection site for a full 15 seconds.

Sometimes people feel itching or redness at the injection site. Call your healthcare provider right away if you have severe pain, swelling, blisters, an open wound, or a dark scab at your injection site. 

If you miss a dose of Bydureon, be sure to administer your missed dose as long as your next regularly scheduled dose is three or more days away. If your missed dose is within one to two days of your next regularly scheduled dose, do not take your missed dose.

Bydureon may cause several side effects, ranging from mild to severe.

Common

Because Bydureon delays gastric emptying, the most common side effects include nausea and vomiting. Nausea commonly happens when first starting the medication and decreases over time when the body gets used the medication. Other common side effects include:

• Headaches
• Stomach upset
• Decreased appetite
• Fatigue
• Diarrhea
• Constipation
• Redness, itchiness, or lump at the injection site

Inform your physician of any worrisome side effects, especially prolonged diarrhea or constipation.

Severe

The following severe reactions are unlikely but may occur when using Bydureon. Contact your physician immediately if you are experiencing any of the conditions below:

• Acute pancreatitis: Symptoms of pancreatitis include persistent, severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting. This may be a sign of the development of acute pancreatitis, in which case the medication should be stopped, you should consult your doctor and not restart taking Bydureon if pancreatitis is confirmed.
• Hypoglycemia: Symptoms of hypoglycemia include shaking, headache, sweating, fatigue, or increased heart rate. Hypoglycemia risks increase if Bydureon is used in conjunction with sulfonylureas or insulin. Consult your physician if you are experiencing hypoglycemia, as dosages of each of your medications may need to be adjusted.
• Acute kidney injury: Taking Bydureon alone or in conjunction with other medications with direct action on the kidneys—especially angiotensin-converting enzyme inhibitors (ACEs), nonsteroidal anti-inflammatory drugs (NSAIDs), and diuretics—may impair renal function. Symptoms of kidney injury include reduced urination, swelling in legs/ankles, confusion, fatigue, and/or nausea. Discontinuing Bydureon and any additional medications may restore kidney function.
• Immunogenicity: Some patients may develop antibodies to exenatide after taking, usually associated with a worsening glycemic response. If you experience a worsening of your glycemic control, cease taking Bydureon and consult your doctor.
• Hypersensitivity: Some may also experience severe allergic reactions to exenatide, such as anaphylaxis or angioedema (swelling under the skin).
• Injection site reactions: A small number of cases of abscess, cellulitis (infection of the cellulite layer or necrosis (tissue death) at the injection site. Surgical treatment may be necessary: consult your physician.

Because Bydureon slows gastric emptying, it has the potential to reduce the rate of absorption of orally administered drugs, for example, acetaminophen. According to the manufacturers, Bydureon has not been studied with Warfarin, but those taking Warfarin in conjunction with Bydureon should have their INR levels checked more frequently in case of potential interaction.

If used simultaneously with insulin or sulfonylureas, the dosage of those drugs may need to be reduced to account for the action of Bydureon.

Bydureon comes with an FDA-mandated black box warning about the risk of thyroid-C cell tumors inherent in taking the drug as a result of animal studies. It is not currently known if taking Bydureon will result in thyroid cancer in humans.

Don't drink alcohol or use recreational drugs while taking Bydureon, as they have the potential to reduce your blood sugar and cause hypoglycemia.

Consult your healthcare provider before stopping Bydureon, as you may need a weaning schedule to prevent blood glucose management repercussions.