What to Know About Bydureon (Exenatide Extended-Release)

Bydureon (exenatide) is used to help manage blood sugar levels in people with type 2 diabetes. It is a type of injectable medication that stimulates insulin secretion called a glucagon-like peptide-1 receptor agonist (GLP-1 RA). Bydureon is available in two forms: as a syringe and as a pen injector. Bydureon is not currently available generically.

Uses

Diabetes is a progressive disease, and sometimes adjustments in medication regimens need to be made to help manage blood sugar as time goes on. Often, people with diabetes can benefit from using an injectable medication (other than insulin) in addition to their pill medications. Non-insulin injectable medicines such as Bydureon as well as Byetta and Victoza (drugs with same active ingredient) 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. Because it is an extended-release medication, it must be injected only once a week at any time of day—as opposed to Byetta, a short-acting form of exenatide, which must be injected twice a day on a strict schedule.

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 11 pounds by month six of taking the medication.

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 1.6%) than Byetta. 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 for those who don't have diabetes. 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.

Before Taking

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 1.6%, 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 such as Glimepiride (amaryl).

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

Precautions and Contraindications

Before taking Bydureon, tell your provider if you have a history of gastrointestinal disease, pancreatitis, gallstones, alcoholism, or high blood triglyceride levels.

Bydureon is not intended for patients with type 1 diabetes. 

Bydureon is considered a Category C medication by the Food and Drug Administration, which means that animal studies have shown possible harm to a fetus when the mother takes this drug. Bydureon should only be used in pregnancy if the potential benefits of use outweigh the potential risks to the fetus. If you become pregnant while taking Bydureon, talk to your doctor.

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)

Dosage

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:

• Dual-chamber pen: carton contains 4 single-dose pens containing 2 mg of exenatide each (a 4-week supply)
• BCise autoinjectors: carton contains 4 single-dose autoinjectors with 2mg exenatide each (a 4-week supply)

The BCise autoinjector is the newest model—ask your doctor about switching from the dual-chamber pen to the BCise. The BCise may be more comfortable and easier to use.

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 BCise should be stored flat in your refrigerator. Before dosing with the BCise, 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.

If you miss a dose of Bydureon, you can take it as long as your next 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.

Side Effects

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

Common

Because Bydureon delays the flow of food from the stomach, 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 to the medication. 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. 

Other common side effects include:

• Headaches
• Decreased appetite
• Fatigue
• Diarrhea
• Constipation

Severe

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

• Prolonged diarrhea or constipation: Having symptoms of diarrhea for more than two days or symptoms of constipation lasting more than three days.
• Acute pancreatitis: Symptoms of pancreatitis (inflammation of the pancreas) 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 Bydureon 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) have been seen at the injection site when using Bydureon. Surgical treatment may be necessary: Consult your physician.

Warnings and Interactions

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.

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.

Bydureon slows the rate at which food is emptied from the stomach, and so any medications taken by mouth, such as Tylenol (acetaminophen), may not be absorbed as quickly as they should. 

According to the manufacturers, Bydureon has not been studied with warfarin, but those taking warfarin in conjunction with Bydureon should have their international normalized ratio (INR) levels checked more frequently (a test measuring blood clotting time) 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.

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.