Bydureon Pen

Exenatide is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently. Bydureon is an extended-release form of exenatide.

Bydureon is used to treat type 2 diabetes. Other diabetes medicines are sometimes used in combination with Bydureon if needed.

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.

Bydureon may also be used for purposes not listed in this medication guide.

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 (cancer that can affect the thyroid, parathyroid, and adrenal glands).

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.

Do not use Bydureon to treat type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). You should not use Bydureon if you have severe kidney disease (or if you are on dialysis), of if you have a severe stomach disorder that causes slow digestion.

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 (cancer that can affect the thyroid, parathyroid, and adrenal glands).

To make sure this medicine is safe for you, tell your doctor if you have:

• kidney disease or a history of kidney transplant;
• problems with digestion;
• a history of pancreatitis or gall stones;
• a history of alcoholism; or
• a history of 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 this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether exenatide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Bydureon.

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 medication 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;
• swelling, weight gain, feeling short of breath, little or no urinating;
• drowsiness, confusion, mood changes, increased thirst, diarrhea;
• dull pain in your middle or lower back;
• severe pain in your upper stomach spreading to your back, vomiting; or
• low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery).

Common side effects may include:

• upset stomach, nausea, vomiting, diarrhea, constipation;
• headache; or
• weight loss.

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.

You should not use Bydureon together with insulin. Do not use Bydureon together with Byetta.

Avoid drinking alcohol. It can lower your blood sugar.

Exenatide can make it harder for your body to absorb other medicines you take by mouth. Tell your doctor about all medicines you use, and those you start or stop using. Other drugs may interact with Bydureon, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Bydureon is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Bydureon is usually injected once every 7 days. Unlike Byetta, 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 Bydureon on your new dosing day if it has been less than 3 days since your last dose.

Bydureon is a powder medicine that must be mixed with a liquid (diluent) before using it. You must give the injection right away after mixing. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Use a different place on your stomach, thigh, or upper arm each time you inject Bydureon. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop using Bydureon for a short time if you become ill. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting. Do not change your medication dose or schedule without your doctor's advice.

Store unused Bydureon powder in the refrigerator, protected from light. Do not freeze, and throw away any medicine that has become frozen.

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

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

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

Overdose can cause severe hypoglycemia (extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure).

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 extra medicine to make up the missed dose.