exenatide (Byetta)

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Pronunciation: ex EN a tide

Brand: Byetta Prefilled Pen

What is the most important information I should know about Byetta?

You should not use this medicine if you have severe kidney disease (or you are on dialysis), or if you have slowed digestion or diabetic ketoacidosis.

You should not use Byetta together with fast-acting or short-acting insulins. Do not use Byetta together with Bydureon.

Stop using this medicine and call your doctor at once if you have nausea and vomiting with severe pain in your upper stomach spreading to your back.

What is Byetta?

This medication guide provides information about the Byetta brand of exenatide. Bydureon 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. Byetta is a short-acting form of exenatide.

Byetta is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Byetta is not for treating type 1 diabetes.

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

What should I discuss with my healthcare provider before using Byetta?

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).

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).

It is not known whether exenatide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Byetta can make birth control pills less effective. If you take birth control pills, take your pill at least 1 hour before your Byetta injection.

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 Byetta on the baby.

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 Byetta.

Exenatide is not approved for use by anyone younger than 18 years old.

How should I use Byetta?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

Byetta is usually injected twice a day, before the morning and evening meals. You must use Byetta within 60 minutes (1 hour) before eating. Your Byetta doses should be given at least 6 hours apart. Do not use Byetta after eating a meal.

Byetta comes in a prefilled injection pen with a "Pen User Manual" showing instructions for using the pen and injecting the medicine. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Never share an injection pen, cartridge, 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.

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 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.

Byetta 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.

Storing unopened (not in use) Byetta: Keep the medicine in its original container. Refrigerate and use until expiration date. Protect from light.

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

Storing opened (in use) Byetta: Store at room temperature and use within 30 days. Protect from heat and bright light. Do not store the injection pen with a needle attached.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Use the missed dose as soon as you remember, but only if you have not yet eaten a meal. Skip the missed dose if you have already eaten a meal, or if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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 should I avoid while using Byetta?

You should not use Byetta together with a fast-acting or short-acting insulin, such as insulin aspart (NovoLOG), insulin glulisine (Apidra), insulin lispro (HumaLOG), or regular insulin (HumuLIN R, NovoLIN R, and others). Do not use Byetta together with Bydureon.

Avoid drinking alcohol. It can lower your blood sugar.

If you take any type of antibiotic, take it at least 1 hour before you use Byetta.

What are the possible side effects of Byetta?

Get emergency medical help if you have signs of an allergic reaction: hives, itching; rapid heartbeats; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • 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, nausea, 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:

  • heartburn, nausea, vomiting, diarrhea, constipation;
  • headache, dizziness;
  • weakness; or
  • feeling jittery.

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 Byetta?

Exenatide can make it harder for your body to absorb other medicines you take by mouth. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an antibiotic;
  • birth control pills;
  • blood pressure medicine;
  • a diuretic or "water pill";
  • insulin or oral diabetes medicine;
  • pain medicine;
  • lovastatin (Advicor, Altoprev, Mevacor); or
  • warfarin (Coumadin, Jantoven).

This list is not complete. Other drugs may interact with Byetta, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about exenatide (Byetta).

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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