Exenatide (ex-EN-a-tide)

Treats type 2 diabetes.

Brand Name(s):

BYDUREON BCise, Byetta 10 MCG, Byetta 5 MCG

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. It is injected into your stomach, thigh, or upper arm.
• Bydureon® and Bydureon® BCise® are given 1 time each week. Byetta® is given 2 times each day. Bydureon® and Bydureon® BCise® are extended-release forms of Byetta®. Do not use these medicines together.
• 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.
• 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. Always inject Bydureon® and insulin separately. You may inject these 2 medicines in the same body area but they should not be injected next to each other.
• Allow the Bydureon® BCise® autoinjector to warm to room temperature for 15 minutes before using it. Shake it well for 15 seconds to mix it evenly. The mixture should appear white to off-white or cloudy and does not contain any particles in it.
• Use a new needle and syringe each time you inject your medicine.
• Never share medicine pens, needles, or syringes. There is a risk of infection if needles, pens, or syringes are used by more than one person.
• Drink extra fluids so you will urinate more often and help prevent kidney problems.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  • Bydureon® or Bydureon® BCise®: Use this medicine as soon as you remember, 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 due 1 or 2 days later. Do not use 2 doses of this medicine fewer than 3 days apart.
  • Byetta®: Skip the missed dose and inject your next regular dose. Never inject a missed dose after a meal.
• Storage instructions:
  • Bydureon®: Store your medicine in the refrigerator in its original carton, and protect it from light. Do not freeze. Do not use the medicine if it has been frozen or if the expiration date has passed. You may also store the single-dose trays at room temperature for up to 4 weeks.
  • Bydureon® BCise®: Store the autoinjector flat in the refrigerator in its original carton, and protect it from light. You may also store this medicine at room temperature for up to 4 weeks. Keep it always clean and away from any spills.
  • Byetta®: Store your new, unused medicine pen in the refrigerator in its original carton, and protect it from light. Do not freeze it. You may store the opened medicine pen in the refrigerator or at room temperature for 30 days. Remove the needle from the pen before you store the medicine. This prevents medicine from leaking and air bubbles from forming in the pen. Throw away the pen after you use it for 30 days, even if it still has medicine in it.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

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

• You should not use prandial insulin while you use Byetta®.
• Take antibiotics or birth control pills at least 1 hour before you inject Byetta®.
• Some medicines can affect how exenatide works. Tell your doctor if you are using any of the following:
  • Acetaminophen
  • Blood pressure medicine
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • NSAID pain or arthritis medicine
  • Other diabetes medicine (including insulin, glimepiride, glipizide, glyburide)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, gallstones, digestion problems (including gastroparesis), a thyroid tumor, pancreas problems, or if you had a kidney transplant.
• This medicine may cause the following problems:
  • Increased risk of thyroid tumor
  • Pancreatitis (swelling of the pancreas)
  • Low blood sugar (when used with other diabetes medicine)
  • Low number of platelets in your blood
  • Kidney problems
  • Gallbladder problems
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Decrease in how much or how often you urinate, lower back or side pain, blood in your urine
• Redness, itching, bump, swelling, or any changes in your skin where the shot was given
• Shaking, trembling, sweating, fast or pounding heartbeat, lightheadedness, hunger, confusion
• Sudden and severe stomach pain, nausea, vomiting, fever, yellow eyes or skin
• Unusual bleeding, bruising, or weakness

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

• Headache
• Mild nausea, constipation, diarrhea, or upset stomach
• Tiredness or weakness

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