Generic name: exenatide (ex EN a tide)
Brand name: Bydureon BCise, Bydureon Pen, Bydureon Tray
Drug class: Incretin mimetics
Bydureon (exenatide) is an extended release injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently. Bydureon is a long-acting form of exenatide.
Bydureon is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. This medicine is not for treating type 1 diabetes.
This medication guide provides information about the Bydureon brand of exenatide. Byetta is another brand of exenatide that is not covered in this medication guide.
Warnings
You should not use Bydureon 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.
You should not use Bydureon if exenatide has ever caused you to have low platelet levels in your blood.
Stop using Bydureon 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 exenatide to treat type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
Bydureon 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.
Before taking this medicine
You should not use Bydureon if you have a personal or family history of thyroid cancer, or if you have multiple endocrine neoplasia type 2 (MEN 2, a cancer that can affect the thyroid, parathyroid, and adrenal glands).
You also should not use Bydureon if you are allergic to exenatide, or if you have:
- a personal or family history of thyroid cancer;
- multiple endocrine neoplasia type 2 (MEN 2, a cancer that can affect the thyroid, parathyroid, and adrenal glands); or
- a history of low levels of platelets (blood cells that help your blood to clot) while using exenatide;.
To make sure Bydureon is safe for you, tell your doctor if you have ever had:
- kidney disease, or a kidney transplant;
- a stomach disorder that causes slow digestion;
- pancreatitis; or
- gall stones.
In animal studies, Bydureon caused thyroid tumors. However, very high doses are used in animal studies. It is not known whether these effects would occur in people using doses recommended for human use. Ask your doctor about your personal risk.
Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
Bydureon is not approved for use by anyone younger than 18 years old.
How should I use Bydureon?
Use Bydureon exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Bydureon is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.
Prepare your injection only when you are ready to give it. You must give the injection right away after mixing.
Bydureon is usually injected once every 7 days. This medicine can be used with or without food and given at any time of the day. Follow your doctor's instructions. You may change your weekly dosing day, but do not inject on your new dosing day if it has been less than 3 days since your last dose.
Your care provider will show you the best places on your body to inject Bydureon. Use a different place each time you give an injection. Do not inject into the same place two times in a row.
You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).
Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.
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.
Bydureon is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
Store Bydureon in its original container. Refrigerate and use until expiration date. Protect from light.
Do not freeze. Throw away the medicine if it has been frozen.
You may also store this medicine at room temperature for up to 4 weeks.
Dosing information
Usual Adult Dose for Diabetes Type 2:
Extended-release (Bydureon; Bydureon BCISE):
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.
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 3 days away. Do not use two doses at one time.
What happens if I overdose?
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).
What to avoid
You should not mix Bydureon with insulin in the same syringe. Do not use Bydureon together with Byetta.
Avoid drinking alcohol. It can lower your blood sugar.
Bydureon side effects
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 Bydureon 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 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;
- swelling in your neck or throat (enlarged thyroid), hoarse voice, trouble swallowing or breathing;
- 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 - little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.
Common Bydureon side effects 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.
What other drugs will affect Bydureon?
Tell your doctor if you use insulin or oral diabetes medicine.
Bydureon can make it harder for your body to absorb other medicines you take by mouth. Tell your doctor about all your other medicines. Other drugs may interact with exenatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.