Bydureon (Exenatide Extended-Release Injection (Pens))

Use Bydureon as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Do not use if solution changes color.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Do not mix Bydureon in the same syringe with insulin.
• Give this medicine at some other site from where you gave your insulin if you are also getting insulin.
• Wash your hands before and after use.
• Follow the diet and workout plan that your doctor told you about.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• Attach new needle before each dose.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Use right away after mixing.
• Take the same day each week.
• Move site where you give the shot each time.
• Take with or without food.
• Do not use if the solution is leaking or has particles.
• Before giving the shot, let it come to room temperature. Do not heat Bydureon (exenatide extended-release injection (pens)).

What do I do if I miss a dose?

• If it is 3 or more days to the time of your next dose, take the missed dose as soon as you think about it and go back to your normal day.
• If it is 1 or 2 days to the time of your next dose, skip the missed dose and go back to your normal day.
• Do not take 2 doses at the same time or extra doses.

• Store in a refrigerator or at room temperature. If stored at room temperature, throw away any part not used after 28 days.
• Do not freeze.
• Do not use if it has been frozen.
• Protect from light.
• Take off the needle after each shot. Do not store this device with the needle on it.
• Keep the cap on the pen when not in use.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Bydureon is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Bydureon or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Bydureon. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Immediate-release:
-Initial dose: 5 mcg subcutaneously twice a day for at least 1 month
-Maintenance dose: Based on clinical response, may increase to 10 mcg subcutaneously twice a day
-Maximum dose: 10 mcg twice a day
-Administer within the 60-minute period before the morning and evening meals; alternatively, may give before the two main meals of the day provided dosing is 6 hours or more apart; do not administer after a meal.

Extended-release:
-Dose: 2 mg subcutaneously once every seven days; administer at any time of day, with or without meals
-Patients may switch from immediate-release to extended-release, although prior treatment with immediate-release exenatide is not necessary.
-For patients who do switch, discontinue immediate-release exenatide on initiation of extended-release; transient elevations in blood glucose may occur and generally improve within the first 2 weeks of initiation.

Comments:
-For patients concomitantly receiving a sulfonylurea, a lower dose of the sulfonylurea may be required to reduce the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

US BOXED WARNINGS:
-Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether this drug causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of exenatide-extended-release-induced rodent thyroid C-cell tumors has not been determined.
-This drug is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Patients should be counseled regarding the potential risk for MTC and inform them of the symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring for serum calcitonin or using thyroid ultrasounds is of uncertain value for detection of MTC in patients treated with exenatide extended-release.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Administration advice:
-Administer subcutaneously in abdomen, thigh, or upper arm region; do not administer IV or IM
-Never share a pen between patients, even if the needle is changed, as this presents a risk for transmission of blood-borne pathogens

Immediate-release (Byetta(R):
-Administer within 60-minute of the morning and evening meals; alternatively, may give before the two main meals of the day provided dosing is 6 hours or more apart.
-Do not administer after a meal; if a dose is missed, resume with next scheduled dose.
Extended-release (Bydureon(R):
-Administer once every 7 days, at any time of the day and with or without meals.
-Administer dose immediately after it is prepared; do not substitute needles or any other components provided with the tray.
-If a dose is missed, administer as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later; then resume usual dosing schedule of once every 7 days (weekly).
-If a dose is missed and the next regularly scheduled dose is 1 or 2 days later, skip the missed dose and resume with the next regularly scheduled dose.
-If necessary, the day of weekly administration can be changed as long as the last dose was administered 3 or more days before.

Storage requirements:
Immediate-release Pens:
-Unopened (not in use): Store in refrigerator 2C to 8C (36F to 46F), do not freeze, protect from light; discard if frozen
-Opened (in-use): May keep unrefrigerated for up to 30 days after opening; keep away from direct heat and light; temperature should not exceed 25C (77F)); discard 30 days after opening.

Extended-release Trays:
-Store in refrigerator 2C to 8C (36F to 46F), do not freeze, protect from light; discard if frozen
-If needed, the tray may be kept out of the refrigerator at 20C to 25C (68F to 77F) for up to 4 weeks

Reconstitution/preparation techniques: Patients should receive proper training from their healthcare provider prior to first use. See product labeling for specific instructions.

General:
-This drug has not been studied in patients with a history of pancreatitis, consider alternative therapy.
-This drug should not be used to treat patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-This drug is not recommended as a first-line therapy in patients with type 2 diabetes mellitus.
-This drug is not a substitute for insulin.

Monitoring:
-Blood glucose and hemoglobin A1C measurements should be measured periodically to assess efficacy.
-Observe for signs and symptoms of pancreatitis.

Patient advice:
-Patients should be advised to never share a pen with another person, even if the needle is changed; patients should understand that sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens
-Counsel patients to report symptoms of thyroid tumors such as a lump in their neck, persistent hoarseness, dysphagia, or dyspnea.
-Patients should be aware that they may experience a reduction in appetite, food intake, and/or weight loss and there is no need to modify the dose due to these effects; nausea may occur early in therapy and generally resolves.
-Patients should be instructed to seek medical advice during periods of stress, such as fever, trauma, infection, or surgery as medical management of diabetes may change.
-Inform patients that hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.
-Patients should be aware of signs and symptoms of hypoglycemia and how it should be managed; patients should be advised to take precautions to avoid hypoglycemia while driving and using machines.