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BYDUREON- exenatide injection, suspension, extended releaseBYDUREON- exenatide kit


  1. Patient Information
  2. Do Not Use Bydureon If:
  3. Before Using Bydureon, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  4. How Should I Use Bydureon?
  5. Your Dose Of Bydureon And Other Diabetes Medicines May Need To Change Because Of:
  6. Active Ingredient:
  7. Inactive Ingredients:
  8. Manufactured For:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Risk of Thyroid C-cell Tumors

Inform patients that exenatide extended-release causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to theirphysician [

BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise.
BYDUREON is not recommended as the first choice of medicine for treating diabetes
BYDUREON is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
It is not known if BYDUREON can be used with mealtime insulin.
BYDUREON and BYDUREON BCise are long-acting forms of the medicine in BYETTA (exenatide). BYDUREON should not be used at the same time as BYETTA or BYDUREON BCise.
It is not known if BYDUREON can be used in people who have had pancreatitis.
It is not known if BYDUREON is safe and effective for use in children.

Do Not Use Bydureon If: 

you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
you are allergic to exenatide or any of the ingredients in BYDUREON.

Before Using Bydureon, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

have or have had problems with your pancreas or kidneys.
have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
are pregnant or plan to become pregnant. BYDUREON may harm your unborn baby. Tell your healthcare provider if you become pregnant while using BYDUREON. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
are breastfeeding or plan to breastfeed. It is not known if BYDUREON passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using BYDUREON.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BYDUREON may affect the way some medicines work and some medicines may affect the way BYDUREON works.

Before using BYDUREON, talk to your healthcare provider about low blood sugar and how to manage it.Tell your healthcare provider if you are taking other medicines to treat diabetes including insulin or sulfonylureas.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How Should I Use Bydureon? 

Read theInstructions for Usethat comes with BYDUREON.
Use BYDUREON exactly as your healthcare provider tells you to.
BYDUREON should be injected right away after you prepare your dose.
Your healthcare provider should show you how to use BYDUREON before you use it for the first time.
BYDUREON is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject BYDUREON into a muscle (intramuscularly) or vein (intravenously).
Use BYDUREON 1 time each week on the same day each week at any time of the day.
BYDUREON may be taken with or without food.
If you miss a dose of BYDUREON, take the missed dose as soon as possible if there are at least 3 days (72 hours) until your next scheduled dose. If there are less than 3 days remaining, skip the missed dose and take your next dose on the regularly scheduled day.Do nottake 2 doses of BYDUREON within 3 days of each other.
You may change the day of the week as long as your last dose was given 3 or more days before.
Do notmix insulin and BYDUREON together in the same injection.
You may give an injection of BYDUREON and insulin in the same body area (such as, your stomach area), but not right next to each other.
Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
Do not share your BYDUREON pen, prefilled syringe, or needles with another person.You may give another person an infection or get an infection from them.

Your Dose Of Bydureon And Other Diabetes Medicines May Need To Change Because Of: 

change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

Active Ingredient: 

exenatide

Inactive Ingredients: 

carboxymethylcellulose sodium, polysorbate 20, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, water for injection. Sodium hydroxide may be added during manufacture of BYDUREON Pen for pH adjustment.

BYDUREON is a registered trademark and BYETTA is a registered trademark of the AstraZeneca group of companies. All other marks are the marks of their respective owners.

Manufactured For: 

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

By:

Amylin Ohio LLC

West Chester, OH 45071

For more information about BYDUREON, go towww.BYDUREON.comor call 1-877-700-7365.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: February 2019



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