Bydureon BCise

In the U.S.

• Bydureon
• BYDUREON BCise
• Byetta

Available Dosage Forms:

• Powder for Suspension, Extended Release
• Solution
• Suspension, Extended Release

Therapeutic Class: Antidiabetic

Pharmacologic Class: Glucagon-Like Peptide-1 Receptor Agonist

Exenatide injection is used together with diet and exercise to treat type 2 diabetes.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of exenatide injection in the pediatric population. Use of Bydureon® BCise™ is not recommended in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of exenatide injection in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving exenatide injection.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Balofloxacin
• Besifloxacin
• Ciprofloxacin
• Enoxacin
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Lanreotide
• Levofloxacin
• Lomefloxacin
• Moxifloxacin
• Nadifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pazufloxacin
• Pefloxacin
• Prulifloxacin
• Rufloxacin
• Sparfloxacin
• Thioctic Acid
• Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Digoxin
• Esmolol
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Labetalol
• Levobunolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propranolol
• Sotalol
• Timolol
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetic ketoacidosis (ketones in the blood) or
• Type 1 diabetes—Should not be used in patients with these conditions. Insulin is needed to control these conditions.

• Gallstones or
• Kidney disease (including kidney transplant) or
• Pancreatitis (inflammation of the pancreas), history of or
• Thyroid tumor—Use with caution. May make these conditions worse.

• Gastroparesis (stomach does not empty food normally) or
• Kidney disease, severe or
• Multiple endocrine neoplasia syndrome type 2 (MEN 2) or
• Stomach or bowel disease, severe or
• Thyroid cancer, history of—Should not be used in patients with these conditions.

This section provides information on the proper use of a number of products that contain exenatide. It may not be specific to BYDUREON BCise. Please read with care.

When you start using this medicine, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. Bydureon® and Bydureon® BCise™ are extended-release forms of Byetta®. If you are changing from Byetta® to Bydureon® or Bydureon® BCise™, you should stop using Byetta®. Do not use these 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 single-dose tray containing: 1 vial of exenatide powder, 1 vial connector, 1 prefilled diluent syringe, and 2 needles. Do not substitute needles or any other components in the tray.

Bydureon® BCise™ is available as a single-dose autoinjector.

This medicine should come with a Medication Guide and a Pen User Manual. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You will be using exenatide at home. Your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected.

This medicine is given as a shot under the skin of your stomach, thighs, or upper arm. 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.

Allow Byetta® to warm to room temperature before you inject it. If the medicine in the pen has changed color, looks cloudy, or if you see particles in it, do not use it.

Use Bydureon® immediately once the powder has been dissolved and transferred to the syringe.

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 sand does not contain any particles in it.

Use a new needle each time you inject your medicine.

Never share medicine pens or single-dose trays with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles, pens, or single-dose trays can result in transmission of infection.

Tell your doctor if you are using birth control pills or an antibiotic. These medicines should be taken at least 1 hour before you use exenatide.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For type 2 diabetes:
  • For injection dosage form (extended-release suspension, Bydureon®):
    • Adults—2 milligrams (mg) injected under the skin once a day, every 7 days, at any time of the day, with or without meals.
    • Children—Use and dose must be determined by your doctor.
  • For injection dosage form (extended-release suspension, Bydureon® BCise™):
    • Adults—2 milligrams (mg) injected under the skin once every 7 days, at any time of the day, with or without meals.
    • Children—Use is not recommended.
  • For injection dosage form (solution, Byetta®):
    • Adults—At first, 5 micrograms (mcg) injected under the skin two times a day at any time within the 60–minute period before the morning and evening meals (or before the two main meals of the day, about 6 hours or more apart). Your doctor may adjust your dose after the first month of therapy to 10 mcg two times a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For patients using Bydureon® or Bydureon® BCise™: If you miss a dose of this medicine, use it as soon as you remember, as long as your next dose is due at least 3 days later. If you miss a dose and the next dose is due 1 or 2 days later, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses of this medicine less than 3 days apart.

For patients using Byetta®: Do not use this medicine after you eat if you forget to use it before the meal. 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.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

For patients using Bydureon®: Store your medicine in the refrigerator, in its original carton, and protect it from light. Do not freeze this medicine, and do not use it 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.

For patients using the Bydureon® BCise™ autoinjector: 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.

For patients using Byetta®:

• 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.
• Remove the needle from the pen before storing Byetta®. This prevents leaking of the remaining medicine and prevents air bubbles from forming in the pen.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Agitation
• bloated or feeling of fullness
• chills
• confusion
• constipation
• cough
• darkened urine
• decreased awareness or responsiveness
• decreased urination or urine output
• depression
• difficulty with swallowing
• dizziness
• dry mouth
• fainting
• fast heartbeat
• fever
• headache
• hives or welts, itching, or skin rash
• hostility
• increase in heart rate
• indigestion
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness
• loss of appetite
• loss of consciousness
• muscle twitching
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid breathing
• rapid weight gain
• seizures
• severe sleepiness
• sunken eyes
• swelling of the face, ankles, or hands
• thirst
• tightness in the chest
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vomiting
• wrinkled skin
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Anxiety
• blurred vision
• cold sweats
• cool, pale skin
• increased hunger
• nervousness
• nightmares
• severe vomiting
• shakiness
• slurred speech

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Belching
• diarrhea
• feeling jittery
• heartburn
• stomach discomfort or upset

• Decreased appetite
• increased sweating
• lack or loss of strength

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• change in taste
• excess air or gas in the stomach or intestines
• loss of taste
• passing gas
• pressure in the stomach
• rash with flat lesions or small raised lesions on the skin
• redness of the skin
• sleepiness or unusual drowsiness
• swelling of the abdomen or stomach area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

This medication guide provides information about the Bydureon brand of exenatide. Byetta is another brand of exenatide that is not covered in this medication guide.

Bydureon BCise is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently. Bydureon is a long-acting form of exenatide.

Bydureon is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Bydureon is not for treating type 1 diabetes.

Bydureon may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have severe kidney disease (or you are on dialysis), slowed digestion, diabetic ketoacidosis, a personal or family history of thyroid cancer, or if you have a type of cancer called multiple endocrine neoplasia type 2 (MEN 2).

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• pain, itching, warmth, swelling, skin sores, blisters, skin changes, or a hard lump where the injection was given;

• swelling in your neck or throat (enlarged thyroid), hoarse voice, trouble swallowing or breathing;

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or

• kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

• indigestion, nausea, vomiting, diarrhea, constipation;

• headache; or

• itching or a small bump where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Bydureon BCise can make it harder for your body to absorb other medicines you take by mouth. Tell your doctor about all your other medicines. Other drugs may affect Bydureon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.