Bydureon BCise is an extended release injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently.

Bydureon BCise is used together with diet and exercise to improve blood sugar control in people with type 2 diabetes mellitus. Bydureon BCise is for use in adults and children at least 10 years old.

Bydureon BCise is not for treating type 1 diabetes.

This medication guide provides information about Bydureon, the long acting form of exenatide. Byetta is another brand of exenatide that is not covered in this medication guide.

Bydureon Pen was discontinued in March 2021. Bydureon BCise Pen is still available. The Bydureon BCise product is an auto-injector that does not need to be mixed. It has a pre-attached hidden needle and contains the same active ingredient as Bydureon pen.

You should not use Bydureon BCise if you have a personal or family history of thyroid cancer, if you have multiple endocrine neoplasia type 2 (MEN 2, a cancer that can affect the thyroid, parathyroid, and adrenal glands), or if you have ever had low platelets while using exenatide.

Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

You should not use Bydureon BCise if exenatide has ever caused you to have low platelet levels in your blood.

Stop using Bydureon BCise and call your doctor at once if you have severe pain in your upper stomach spreading to your back, with nausea, vomiting, and a fast heart rate. These could be symptoms of pancreatitis.

Do not use this medicine to treat type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Bydureon BCise is an extended-release form of exenatide administered as an injection once every seven days. The dose can be administered at any time of day, with or without meals. Follow your doctor's instructions.

Use Bydureon BCise exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Bydureon BCise is injected under the skin.

Ask your doctor or pharmacist if you don't understand how to use an injection. Do not allow a young child to use this medicine without help from an adult.

Bydureon BCise is usually injected once every 7 days. You may give the injection with or without food at any time of the day. Follow your doctor's instructions. If you change your weekly dosing day, choose a day that is at least 3 days past your last dose.

Your healthcare provider will show you where to inject Bydureon. Do not inject into the same place two times in a row.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Never share an injection pen or syringe even if you changed the needle. Sharing these devices can pass infections from person to person.

Bydureon can lower your platelet counts for up to 10 weeks after you stop using this medicine. You may need frequent medical tests while using this medicine and for a short time after you stop.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store this medicine in its original container. Refrigerate and use until expiration date. Protect from light.

Do not freeze and throw away the medicine if it has been frozen.

You may also store Bydureon BCise at room temperature for up to 4 weeks.

Usual Adult Dose of Bydureon BCisefor Diabetes Type 2:

Extended-release: Initial dose - 2 mg subcutaneously once every 7 days (weekly)
-May administer any time of day, with or without meals; see dose adjustments for information on missed doses and changing administration day
-Prior treatment with immediate-release product is not required; for patients who do switch, discontinue immediate-release at initiation of extended-release; transient blood glucose elevations may occur for approximately 2 to 4 weeks after switch
-Switching extended-release products may be done at next regularly scheduled dose

Comments:
-This drug has not been studied in patients with a history of pancreatitis and therefore, other therapies should be considered in these patients.
-Extended-release exenatide is not recommended as first-line therapy because of the uncertainty of the risk of thyroid C-cell tumors.
-Patients may experience transient (approximately 2 to 4 weeks) elevation in blood sugar when switching from immediate-release exenatide to extended-release.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Usual Pediatric Dose for Diabetes Type 2:

10 years and older:
Extended-release: 2 mg subcutaneously once every 7 days (weekly)
-May administer any time of day, with or without meals; see dose adjustments for information on missed doses and changing administration day

Comments:
-Extended-release exenatide is not recommended as first-line therapy because of the uncertainty of the risk of thyroid C-cell tumors.
-This drug is not indicated for use in patients with type 1 diabetes.
-This drug has not been studied in patients with a history of pancreatitis and therefore, other therapies should be considered in these patients.

Use: As an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years and older with type 2 diabetes mellitus.

You should not use Bydureon if you are allergic to exenatide, or if you have:

• multiple endocrine neoplasia type 2 (tumors in your glands);

• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or

• a history of low levels of platelets (blood cells that help your blood to clot) while using exenatide.

To make sure Bydureon BCise is safe for you, tell your doctor if you have::

• kidney disease, or a kidney transplant;

• a stomach disorder that causes slow digestion;

• pancreatitis; or

• gallbladder disease.

Bydureon has caused thyroid tumors in animal studies. It is not known if this could occur in humans. Ask your doctor about the risk.

Follow your doctor's instructions about using Bydureon BCise if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

Ask a doctor if it is safe to breastfeed while using this medicine.

Bydureon is not approved for use by anyone younger than 10 years old.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 3 days. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause severe nausea and vomiting, or signs of low blood sugar (headache, hunger, irritability, dizziness, feeling shaky).

You should not mix Bydureon with insulin in the same syringe. Do not use Bydureon together with Byetta.

Get emergency medical help if you have signs of an allergic reaction to Bydureon: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people using exenatide have had serious or fatal bleeding caused by low levels of platelets (blood cells that help your blood to clot). Stop using Bydureon and call your doctor right away if you have unusual bleeding or bruising.

Stop using Bydureon BCise and call your doctor at once if you have:

• severe ongoing nausea and vomiting;

• pain, warmth, swelling, an open wound or scab, or other skin changes where the injection was given;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• signs of a thyroid tumor - swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath;

• pancreas or gallbladder problems - pain in your upper stomach spreading to your back, nausea and vomiting, fever, fast heart rate, yellowing of your skin or eyes;

• low blood sugar - headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or

• kidney problems - swelling, urinating less, feeling tired or short of breath.

Common Bydureon side effects may include:

• indigestion, nausea, vomiting, diarrhea, constipation;

• headache; or

• itching or a small bump where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor if you use insulin.

Exenatide can make it harder for your body to absorb other medicines you take by mouth. Tell your doctor about all your other medicines, especially:

• oral diabetes medicine;

• blood pressure medicine;

• warfarin (Coumadin, Jantoven);

• diuretic or "water pill"; or

• a pain medicine.

This list is not complete. Other drugs may interact with exenatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.