Exenatide Injection

pronounced as (ex en' a tide)

Brand Name(s): Bydureon®, Bydureon BCISE®, Byetta®

Why is this medicine prescribed?

Exenatide injection is used with diet and exercise to lower blood sugar in certain people with type 2 diabetes (condition in which blood sugar is too high because the body does not make or use insulin normally). Exenatide is in a class of medications called incretin mimetics. It works by stimulating the pancreas to secrete insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy.

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Exenatide injection comes as a solution (liquid) in a prefilled dosing pen to inject subcutaneously (just under the skin). It is injected twice a day no more than 1 hour before meals. It can be injected before morning and evening meals or before two main meals of the day, about 6 hours apart. Do not inject it after meals.

Use exenatide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of exenatide injection and may increase your dose after 1 month.

Exenatide controls diabetes but does not cure it. Continue to use exenatide injection even if you feel well. Do not stop using exenatide injection without talking to your doctor.

You will be shown how to use the injection pen by your doctor or nurse. You will also be given instructions for use with the medicine. This will tell you how to inject it. Read it carefully. Ask your doctor or pharmacist if you have any questions on how to inject the medicine.

You will need to buy needles separately. Ask your doctor or pharmacist what type of needles you will need to inject your medication. Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Dispose of needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture resistant container.

Always look at your exenatide solution before you inject it. It should be as clear, colorless, and free of particles. Do not use exenatide injection if it is colored, cloudy, contains solid particles, or if the expiration date has passed.

Do not mix insulin with exenatide injection to combine into a single injection.

Inject exenatide in thigh, stomach, or upper arm. Never inject exenatide into a vein or muscle.

You will be given the Medication Guide when you begin treatment with exenatide and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

What special precautions should I follow?

Before using exenatide injection,

  • tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using exenatide injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • the following nonprescription product may interact with exenatide injection: acetaminophen. Be sure to let your doctor and pharmacist know that you are taking this medication before you start using exenatide injection. Do not start this medication while using exenatide injection without discussing with your healthcare provider.
  • if you are taking oral contraceptives (birth control pills) or antibiotics, take them at least 1 hour before you use exenatide injection. If you have been told to take these medications with food, take them with a meal or snack at a time when you do not use exenatide i injection.
  • tell your doctor if you have ever had serious bleeding due to thrombocytopenia (a low number of platelets [type of blood cell needed for blood clotting]) after receiving exenatide injection. Your doctor will probably tell you not to use exenatide injection.
  • tell your doctor if you have had a kidney transplant or if you have or have ever had severe stomach problems, including gastroparesis (slowed movement of food from the stomach to the small intestine) or other problems digesting food; pancreatitis (swelling of the pancreas) or other pancreas problems; gallstones (solid deposits that form in the gallbladder) or other gall bladder problems; or kidney disease. Also tell your doctor if you have recently had diarrhea, nausea, or vomiting or if you cannot drink liquids by mouth, which may cause dehydration (loss of a large amount of body fluids).
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using exenatide, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using exenatide injection.

What special dietary instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet.

What should I do if I forget to take a dose?

If you miss a dose of exenatide injection, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222

. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

  • nausea
  • vomiting
  • symptoms of hypoglycemia

What side effects can this medicine cause?

This medication may cause changes in your blood sugar. Signs and symptoms of low blood sugar may include dizziness or lightheadedness, irritability, sweating, hunger, drowsiness, shakiness, weakness, headache, fast heart rate and feeling jittery. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Exenatide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea
  • vomiting
  • diarrhea
  • constipation
  • decreased appetite
  • jittery feeling
  • dizziness
  • heartburn
  • headache
  • weakness

Some side effects can be serious. If you experience any of the following symptoms, stop using exenatide and call your doctor immediately or get emergency medical treatment:

  • ongoing pain that begins in the upper left or middle of the stomach but may spread to the back with or without vomiting
  • hives; rash; itching; swelling of the face, throat, tongue, lips, or eyes; difficulty breathing or swallowing; dizziness or fainting; or rapid heartbeat
  • pain in the right or upper middle stomach area, fever, clay-colored stools, or yellowing of skin or eyes
  • changes in the color or amount of urine
  • urinating more or less often than usual
  • swelling of the arms, hands, feet, ankles, or lower legs
  • unusual bleeding or bruising

Exenatide may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone (

1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it away from light and heat. Store unused exenatide pens in their original carton in the refrigerator, protected from light. Do not freeze. Once in use, exenatide pens can be stored at room temperature (up to 77°F [25°C]) for up to 30 days. Do not store exenatide pens with the needle attached. When traveling, be sure to keep exenatide pens dry.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What other information should I know?

Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to exenatide. Your doctor will also tell you how to check your response to this medication by measuring your blood sugar levels at home. Follow these instructions carefully.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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