Exenatide (Injection)

Introduction

Exenatide (ex-EN-a-tide)

Treats type 2 diabetes.

Brand Name(s)

Byetta, Bydureon

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. The shot should be given into your stomach, thigh, or upper arm.
• Bydureon® is given 1 time each week. Byetta® is given 2 times each day. Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.Bydureon® is an extended-release form of Byetta®. Do not use both medicines together.
• Byetta® comes in a prefilled pen that you will use to inject it. Each pen contains enough medicine for 60 doses.
• Bydureon® comes in a tray that contains powder and liquid. Each train contains enough medicine for 1 dose. Use only the needles that come with the tray.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Do not use Byetta® if it looks cloudy or has changed color. Use a new needle each time you inject your medicine.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use Bydureon® immediately once the powder has been dissolved and transferred to the syringe. The mixture should be off-white or cloudy. Use a new needle and syringe each time you inject your medicine.
• Never share medicine pens, needles, or syringes with other people for any reason. There is a risk of infection if needles, pens, or syringes are used by more than one person.
• It is important to follow the special meal plan your doctor gave you. This is necessary for the medicine to work properly. Exercise regularly and test for sugar in your blood or urine as directed.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• Bydureon® patients: Use this medicine as soon as you remember if you miss a dose, as long as your next dose is due at least 3 days later. Skip the missed dose and go back to your regular dosing schedule if your next dose is 1 or 2 days later. Do not use 2 doses of this medicine fewer than 3 days apart.
• Byetta® patients: Do not use this medicine after you eat. Wait until 1 hour before your next meal, and use the medicine at that time. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Bydureon® patients: Store your medicine in the refrigerator, in the original carton, and protect it from light. Do not freeze this medicine, and do not use the medicine if it has been frozen. You may store the unopened medicine in the refrigerator until the expiration date on the package or at room temperature for up to 4 weeks.
• Byetta® patients: Store your new, unused medicine pen in the refrigerator, in the original carton, and protect it from light. Do not freeze this medicine, and do not use the medicine if it has been frozen. You may store the opened medicine pen in the refrigerator or at room temperature for 30 days. Throw away any unused medicine after 30 days.
• Byetta® patients: Remove the needle from the pen before you store the medicine. This prevents medicine from leaking and air bubbles from forming in the pen.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using insulin. You should not use prandial insulin (such as Apidra®, Lantus®) while you use Byetta®.
• Make sure your doctor knows if you use diabetes medicine that you take by mouth (such as chlorpropamide, glimepiride, glipizide, glyburide, nateglinide, repaglinide, tolbutamide, Diabeta®, Glucotrol®, Orinase®, Prandin®, or Starlix®), or a blood thinner (such as warfarin or Coumadin®).
• This medicine may affect how other oral medicines work. Tell your doctor if you also use birth control pills or an antibiotic. These medicines should be taken at least 1 hour before you use exenatide.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding or if you have kidney problems, a thyroid tumor, or a history of pancreas problems. Tell your doctor if you have digestion problems (such as slow stomach emptying or gastroparesis).
• Bydureon® patients: Tell your doctor right away if you have a lump or swelling in your neck or throat and you use extended-release exenatide. Also tell your doctor if you have trouble swallowing or breathing, or if your voice gets hoarse. These could be symptoms of a thyroid tumor.
• Pancreatitis may occur while you use this medicine. Stop using this medicine and check with your doctor right away if you have stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.
• This medicine is only part of a complete program for controlling diabetes. Diet, exercise, and blood sugar control are also important.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, slurred speech, confusion, shakiness, fainting
• Decrease in how much or how often you urinate
• Sudden and severe stomach pain, nausea, vomiting, fever, and lightheadedness
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Mild nausea, constipation, diarrhea, upset stomach, or acid indigestion
• Redness, itching, bump, swelling, or any changes in your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088