What to Know About Bydureon (Exenatide Extended-Release)

Bydureon (exenatide) is an injectable medication prescribed to help manage blood sugar levels in people with type 2 diabetes. It belongs to a class of drugs known as GLP-1 RAs (also called incretin mimetics) that work by stimulating secretion of glucagon-like peptide-1 receptor agonist (GLP-1 RA). Bydureon is available in two forms: as an injection to be administered with a syringe and needle and as a pre-loaded pen injector. Bydureon is not available generically.

Uses

Bydureon stimulates the pancreas to secrete insulin when it comes into contact with glucose. Because it is an extended-release medication, it needs to be injected only once a week at any time of day (as opposed to Byetta, which must be injected twice a day according to a strict schedule).

In clinical trials, Bydureon has been found to help to reduce A1C (a measurement of average blood glucose levels over three months) by about 1.6%. Exenatide has been found to have other benefits, including preservation of the function of beta cells, which are responsible for making insulin in the pancreas and promoting weight loss in people with type 2 diabetes.

Off-Label Uses

Although helpful for weight loss, Bydureon is not approved by the Food and Drug Administration (FDA) as a weight-loss drug. However, it has been used for that purpose, although rarely.

Before Taking

Bydureon typically is not prescribed as a first-line treatment for diabetes on its own. If it's used as initial treatment, the drug usually is prescribed alongside metformin and, in some cases, another treatment as well. Clinical guidelines from the American Diabetes Association recommend this approach for patients with high risk factors such as cardiovascular or kidney conditions.

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 FDA, meaning in animal studies it was found to do possible harm to a fetus whose mother was given the drug. For that reason, Bydureon should be taken during pregnancy only if it's clear the benefits will be greater than the potential risks of doing so. Anyone who becomes pregnant while taking Bydureon should let their doctor know right away.

Because Bydureon has not been studied for pediatric use, it should not be prescribed for children or teenagers.

Dosage

According to the manufacturer, the standard dosage for people with type 2 diabetes is one 2-milligram (mg) injection every seven days, on the same day each week, but at any time of day, with or without food. Check your prescription and talk to your doctor to make sure you are taking the right dose for you.

Bydureon is available in the following forms:

• Dual-chamber pen: Four single-dose pens containing 2 mg of exenatide each (a 4-week supply)
• BCise autoinjectors: Four single-dose auto injectors containing 2 mg of exenatide each (a 4-week supply)

How to Take and Store

Bydureon BCise injectors should be stored flat in the refrigerator. Before using one it must be brought to room temperature for 15 minutes and then shaken vigorously up and down for at least 15 seconds with the orange cap pointing up.

Bydureon should be injected subcutaneously (into the fatty tissue just beneath the surface of the skin—not into a muscle or vein). It can be administered at the same sites as insulin—the abdomen (two inches below the belly button), outer thighs, or the backs of the upper arms. The same area can be injected each week, but the exact location should be changed. To ensure you get the full dose, 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 a one or 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, which tend to diminish over time as the body gets used to the medication. Other common, albeit minor, side effects include itching and redness at the 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 and warrant immediate medical care:

• Prolonged GI symptoms: Diarrhea for more than two days or constipation lasting longer 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. If you experience these symptoms, stop taking Bydureon and call your doctor.
• Hypoglycemia: Symptoms of hypoglycemia (low blood glucose) include shaking, headache, sweating, fatigue, or increased heart rate. The risk of this complication increases if Bydureon is taken along with a sulfonylurea or insulin, in which case dosages of these medications may need to be adjusted.
• Acute kidney injury: Taking Bydureon alone or in conjunction with other medications that directly affect the kidneys—especially angiotensin-converting enzyme inhibitors (ACEs), nonsteroidal anti-inflammatory drugs (NSAIDs), and diuretics—may impair the function of this organ. Symptoms include reduced urination, swelling in the legs or ankles, confusion, fatigue, and/or nausea. Discontinuing Bydureon and any additional medications may restore kidney function.
• Immunogenicity: Some people develop antibodies to Bydureon while taking it, which typically is characterized by a worsening glycemic response. If this happens to you, stop taking the drug and consult your doctor.
• Hypersensitivity: Some may also experience severe allergic reactions to exenatide, such as anaphylaxis or angioedema (swelling under the skin).

Warnings and Interactions

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

Even so, Bydureon is contraindicated for people with a personal or family history of medullary thyroid cancer (MTC) as well as for those 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 manufacturer, Bydureon has not been studied with warfarin, but people 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.

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.