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Frequently Asked Questions
You should not use this medicine if you have severe kidney disease (or you are on dialysis), slowed digestion, diabetic ketoacidosis, a personal or family history of thyroid cancer, or if you have a type of cancer called multiple endocrine neoplasia type 2 (MEN 2).
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.
Exenatide is an 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. Bydureon is not for treating type 1 diabetes.
Bydureon may also be used for purposes not listed in this medication guide.
You should not use this medicine if you are allergic to exenatide, or if you have:
- severe kidney disease (or if you are on dialysis);
- a severe stomach disorder that causes slow digestion; or
- diabetic ketoacidosis (call your doctor for treatment with insulin).
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).
Tell your doctor if you have ever had:
- kidney disease, or a kidney transplant;
- problems with digestion;
- pancreatitis or gall stones;
- alcoholism; or
- high triglycerides (a type of fat in blood).
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.
It is not known whether exenatide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Bydureon on the baby.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
Exenatide is not approved for use by anyone younger than 18 years old.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
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. Do not use Bydureon if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.
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. Bydureon 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.
Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.
Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and 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, blurred vision, headache, and tiredness.
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.
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 Bydureon, and throw away the medicine if it has been frozen.
You may also store Bydureon at room temperature for up to 4 weeks.
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.
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 use Bydureon together with insulin. Do not use Bydureon together with Byetta.
Avoid drinking alcohol. It can lower your blood sugar.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:
- pain, itching, warmth, swelling, skin sores, blisters, skin changes, or a hard lump where the injection was given;
- swelling in your neck or throat (enlarged thyroid), hoarse voice, trouble swallowing or breathing;
- pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
- 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 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.
Exenatide 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 affect Bydureon, 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.
Your pharmacist can provide more information about exenatide (Bydureon).
|Brand Name Examples||Supplied As||Strength|
|Bydureon BCise||suspension, extended release||2 mg/0.85 mL|
|Byetta Prefilled Pen||suspension, extended release||2 mg/0.85 mL|
|Generic Examples||Supplied As||Strength|
|exenatide||suspension, extended release||2 mg/0.85 mL|