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Bydureon

Generic name: exenatide synthetic

What is Bydureon?

  • Bydureon is an injectable prescription medicine that may improve blood sugar (glucose) in adults and children who are 10 years of age and older 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 for use in people with type 1 diabetes.
  • 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 younger than 10 years of age

What is the most important information I should know about Bydureon?

Bydureon may cause serious side effects, including:

  • Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats or mice, Bydureon and medicines that work like Bydureon caused thyroid tumors, including thyroid cancer. It is not known if Bydureon will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
  • 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).

Who should not use Bydureon?

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 have had a severe allergic reaction to exenatide or any of the ingredients in Bydureon. See below for a complete list of ingredients in Bydureon. Symptoms of a severe allergic reaction with Bydureon may include:
    • swelling of your face, lips, tongue, or throat
    • fainting or feeling dizzy
    • problems breathing or swallowing
    • very rapid heartbeat
    • severe rash or itching
  • you have a history of low blood platelet count from using exenatide medicines (drug-induced thrombocytopenia).

What should I tell my healthcare provider before using 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.

Especially tell your healthcare provider if you take:

  • other medicines to treat diabetes, including insulin or sulfonylureas.
  • a water pill (diuretic).
  • a blood pressure medicine.
  • warfarin.
  • a pain medicine.

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 the instructions for use that 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.
  • Caregivers should help children with mixing and injecting Bydureon.
  • 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 not take 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 not mix 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.

What are the possible side effects of Bydureon?

Bydureon may cause serious side effects, including:

  • See "What is the most important information I should know about Bydureon?".
  • inflammation of your pancreas (pancreatitis). Stop using Bydureon and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
  • low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Bydureon with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include:
    • dizziness or light-headedness
    • sweating
    • confusion or drowsiness
    • headache
    • blurred vision
    • slurred speech
    • shakiness
    • fast heartbeat
    • anxiety, irritability, or mood changes
    • hunger
    • weakness
    • feeling jittery
  • kidney problems. In people who have kidney problems, nausea, vomiting and diarrhea, may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. These kidney problems include kidney failure. Dialysis or a kidney transplant may be needed.
    • While taking Bydureon: Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
  • stomach problems. Other medicines like Bydureon may cause severe stomach problems. It is not known if Bydureon causes or worsens stomach problems.
  • serious allergic reactions. Stop using Bydureon, and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing. See “Who should not use Bydureon?
  • low blood platelet count (drug-induced thrombocytopenia). BYDUREON may cause the number of platelets in your blood to be reduced. When your platelet count is too low, your body cannot form blood clots. You could have serious bleeding that could lead to death. Stop using BYDUREON and call your healthcare provider right away if you have unusual bleeding or bruising. Your blood platelet count may continue to be low for about 10 weeks after stopping BYDUREON.
  • injection-site reactions. Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use Bydureon. Some of these injection-site reactions have required surgery. Call your healthcare provider if you have any symptoms of an injection-site reaction, including severe pain, swelling, blisters, an open wound, a dark scab.
  • gallbladder problems. Gallbladder problems have happened in some people who take Bydureon or other medicines like Bydureon. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:
    • pain in your upper stomach (abdomen)
    • yellowing of skin or eyes (jaundice)
    • fever
    • clay-colored stools

The most common side effects of Bydureon may include nausea, diarrhea, headache, vomiting, constipation, itching at the injection site, a small bump (nodule) at the injection site, indigestion.

Nausea is most common when you first start using Bydureon, but decreases over time in most people as their body gets used to the medicine.

Talk to your healthcare provider about any side effect that bothers you or does not go away.

These are not all the possible side effects of Bydureon. For more information, ask your healthcare provider or pharmacist.

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

Keep Bydureon and all medicines out of the reach of children.

General information about the safe and effective use of Bydureon

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Bydureon for a condition for which it was not prescribed. Do not give your Bydureon to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Bydureon that is written for health professionals.

How should I store Bydureon?

How to store your Single-Dose Trays of Bydureon

  • Store your Bydureon trays in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • If needed, you can keep your Bydureon tray out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks.
  • Protect Bydureon from light until you are ready to prepare and use your dose.
  • Do not freeze Bydureon trays.
  • Do not use Bydureon past the expiration date. The expiration date is labeled EXP and can be found on the paper cover of each tray.
  • Keep Bydureon, and all medicines, out of the reach of children.

How to store your Bydureon Pen

  • Store your Bydureon Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Protect pens from light until you are ready to prepare and use your dose.
  • Do not use pens past the expiration date.
  • Do not freeze Bydureon. Do not use Bydureon if it has been frozen.
  • Keep Bydureon in its sealed tray until ready for use.
  • If needed, you can keep your Bydureon Pen out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks.
  • Keep Bydureon Pen, and all medicines, out of the reach of children.

What are the ingredients in Bydureon?

Active Ingredient: exenatide

Inactive Ingredients in powder: polylactide-co-glycolide and sucrose

Inactive Ingredients in liquid (diluent): 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.

For more information about Bydureon call 1-800-236-9933.

Instructions for use for Bydureon

Bydureon (by-DUR-ee-on) Single-Dose Tray

(exenatide extended-release) for injectable suspension

Before using Bydureon, your healthcare provider should show you how to use it the right way.

Read these Instructions for Use before you start using Bydureon SingleDose Tray and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Getting ready

Bydureon Single-Dose Tray is not for self-injection by people who are blind or cannot see well.

Supplies needed to give your Bydureon Single-Dose Tray injection (not all supplies are included):

  • 1 Bydureon Single-Dose Tray that contains:
    • 1 Bydureon vial
    • 1 Syringe
    • 2 Needles
    • 1 Vial connector
  • alcohol swab
  • a clean flat surface
  • sharps container for throwing away used needles, vials, and syringes. See step 4h "Disposing of used Needles and Syringes."

Your guide to your Bydureon Single-Dose Tray

• Single-dose tray

Bydureon single dose tray.

Keep this flap open so you can refer to it as you go through the steps.

Image showing parts of the Bydureon single-dose tray.

Your guide to the parts

  • Single-dose tray

Image showing the insides of the Bydureon single-dose tray.

What is Inside

To take the correct dose, read each page so that you do every step in order.

This step-by-step guide is divided into 4 sections:

  • Getting Started
  • Connecting the Parts
  • Mixing the Medicine and Filling the Syringe
  • Injecting the Medicine

How to store your Single-Dose Trays of Bydureon

  • Store your Bydureon trays in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • If needed, you can keep your Bydureon tray out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks.
  • Protect Bydureon from light until you are ready to prepare and use your dose.
  • Do not freeze Bydureon trays.
  • Do not use Bydureon past the expiration date. The expiration date is labeled EXP and can be found on the paper cover of each tray.
  • Keep Bydureon, and all medicines, out of the reach of children.

1. Getting Started

1a) Take a Single-Dose Tray from the refrigerator.

1b) Wash your hands. Prepare to clean your injection site with soap and water or an alcohol swab prior to injecting your medicine.

Peel back the paper cover to open to open the Bydureon single-dose tray.

  • Peel back the paper cover to open.
  • Remove the syringe. The liquid in the syringe should be clear with no particles in it. It is okay if there are bubbles.
  • Place the needle, vial connector package, vial, and syringe on a clean, flat surface.

Pick up the needle, and twist off the blue cap.

  • Pick up the needle, and twist off the blue cap.
  • Set the covered needle aside. You will use it later.
  • There is a spare needle in the tray if you need it.

Pick up the vial of Bydureon.

  • Pick up the vial.
  • Tap the vial several times against a hard surface to. loosen the powder.

	 Use your thumb to remove the green cap from the Bydureon vial.

  • Use your thumb to remove the green cap.
  • Put the vial aside.

2. Connecting the Parts

Peel off the paper cover on. the vial connector package.

  • Pick up the vial connector package and peel off the paper cover. Do not touch the orange connector inside.

Hold the vial connector package in one hand and the Bydureon vial in the other.

  • Hold the vial connector package.
  • In your other hand, hold the vial.

Press the top of the Bydreon vial firmly into the orange connector.

  • Press the top of the vial firmly into the orange connector.

hen lift the vial with the orange connector now attached out of the clear package.

  • Then lift the vial with the orange connector now attached out of the clear package.

Image showing  Bydrueon vial with orange connector on top.

  • This is what the vial should now look like.
  • Put it aside for later.

Pick up you Bydureon syringe.

  • Pick up the syringe.
  • With your other hand, firmly grasp the 2 gray. squares on the white cap.

Break off the cap with a snap.

  • Break off the cap.
  • Be careful not to push in the plunger.
    It's like snapping a stick.
  • Just like you might break a stick, you are breaking off the cap.

Image of a broken-off cap.

  • This is what the broken-off cap looks like.
  • You will not be using the cap and can throw it away.

Image showing what the syringe for your Bydureon should now look like.

  • This is what the syringe should now look like.

Twisting the orange connector onto the Bydureon syringe.

  • Now, pick up the vial with the orange connector attached.
  • Twist the orange connector onto the syringe until. snug. While twisting, be sure to grasp the orange connector. Do not over tighten.

Bydureon syringe and vial connected with orange connector.

  • This is how the parts should now look when they are connected.
    Syringe and orange connector pictured up close.

3. Mixing the Medicine and Filling the Syringe

Important: During these next steps, you will be mixing the medicine and filling the syringe. After you mix the medicine, you must inject it. You cannot save the mixed medicine to inject at a later time.

Use your thumb to push down on the plunger of your Bydureon until it stops.

  • With your thumb, push down the plunger until it. stops.
  • The plunger may feel like it is springing back a little.
    Keep pushing down on the plunger until you are ready to draw up a dose.
    For steps 3a to 3f, keep pushing down on the plunger with your thumb.

Hold the plunger down and shake hard. Keep shaking until the liquid and powder are mixed well.

  • Hold the plunger down and shake hard. Keep shaking until the liquid and powder are mixed well.
  • The vial will not come off. The orange connector will keep it attached to the syringe.
    Shake like you would a mixture of oil and vinegar for a salad dressing.
    Shake hard like you would shake a bottle of oil-and-vinegar salad dressing.

The Bydureon medicine will look cloudy when mixed well.

  • When the medicine is mixed well, it should look cloudy.

If you can see clumps of powder in the vial it is not mixed well. Keep shaking.

  • If you see clumps of dry powder on the sides or bottom of the vial, the medicine is not mixed well.
  • Shake hard again until well mixed.
  • Keep pushing down on the plunger while shaking.
    If you have any questions or are not sure if your Bydureon is mixed well, call 1-800-236-9933 for help.

Hold the Bydureon vial upside down so that the syringe is pointing up.

  • Now, hold the vial upside down so the syringe is pointing up. Continue to hold the plunger in place with your thumb.

Gently tap the Bydureon vial.

  • Gently tap the vial with the other hand. Continue to hold the plunger in place.
  • The tapping helps the medicine drip down. It is okay if there are bubbles.

To draw up the medicine, pull the plunger down beyond the black dashed dose line.

  • Pull the plunger down beyond the black dashed dose line.
  • This draws the medicine from the vial into the syringe. You may see air bubbles. This is normal.
  • A little bit of liquid may cling to the sides of the vial.

Use one hand to hold the plunger in place so it does not move.

  • With 1 hand, hold the plunger in place so it does not move.

With the other hand, twist the orange connector to release it from the syringe.

  • With the other hand, twist the orange connector to remove it. from the syringe.
  • Be careful not to push in the plunger.

Image showing what your Bydureon syringe should look like when a dose has been drawn up and it's ready to use.

  • This is what the syringe should. now look like.

4. Injecting the Medicine

Twist the needle onto the Bydureon syringe.

  • Pick up the needle. Twist the needle onto the syringe until snug. Do not remove the needle cover yet.

Important: Read the next steps carefully and look closely at the pictures. This helps. you get the correct dose of medicine.

Slowly push in the plunger so the top of the plunger lines up with the black dashed Dose Line.

  • Slowly push in the plunger so the top of the plunger lines up with the black dashed dose line.
  • Then, take your thumb off the plunger.
    Image showing top of plunger line for on Bydureon syringe.

To help ensure you get the correct dose, the top of the plunger must stay lined up with the black dashed dose line as you go through the next steps.

  • The top of the plunger must stay lined up with the black dashed dose line as you go through the next steps. This will help you get the correct dose of medicine.
  • Put aside the syringe with the needle attached.

Important: It is normal to see a few bubbles in the mixture. The bubbles will not harm you or affect your dose.

Image showing areas of the body where Bydureon can be injected - stomach, thigh and back of upper arm.

  • You can inject the medicine in your stomach area (abdomen), your thigh, or the back of your upper arm.
  • Each week you can use the same area of your body but choose a different injection site in that area.
  • Gently clean the site you choose with soap and water or an alcohol swab.

Now, pick up the Bydureon syringe and hold it near the black dashed Dose Line.

  • Now, pick up the syringe and hold it near the black dashed dose line.

Pull the needle cover straight off. Do not twist.

  • Pull the needle cover straight off. Do not twist.
  • Be careful not to push in the plunger.
  • When you remove the cover, you may see 1 or 2 drops of liquid. This is normal.

Insert the Bydureon needle into your skin then push down on the plunger until it stops.

  • Insert the needle into your skin (subcutaneously). To inject your full dose, push down on the plunger with your thumb until it stops.
  • Withdraw the needle.
  • Be sure to use the injection technique recommended by your healthcare provider.

Sharps container.

  • Disposing of used Needles and Syringes:
    • Put your used needles and syringes in a FDAcleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
    • If you do not have a FDA-cleared sharps disposal container, you may use a household container that. is:
      • made of a heavy-duty plastic,
      • can be closed with a tight-fitting, punctureresistant lid, without sharps being able to come out,
      • upright and stable during use,
      • leak-resistant, and
      • properly labeled to warn of hazardous waste inside the container.
    • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

Please keep these Instructions for Use for your next dose.

Common Questions and Answers for your Bydureon Single-Use Tray

1. After I mix the medicine, how long can I wait before taking the injection?

You must take your injection of Bydureon right after mixing it. If you do not inject Bydureon right away, the medicine will start to form small clumps in the syringe. These clumps can clog the needle when you take the injection (see question 7).

2. How do I know that the medicine is mixed well?

When the medicine is mixed well, it should look cloudy. There should not be any dry powder on the sides or bottom of the vial. If you do see any dry powder, shake hard while continuing to push down on the plunger with your thumb. (This question relates to the steps shown above in 3. Mixing the Medicine and Filling the Syringe)

3. I am ready to take the injection. What should I do if I see air bubbles in the syringe?

It is normal for air bubbles to be in the syringe. The air bubbles will not harm you or affect your dose. Bydureon is injected into your skin (subcutaneously). Air bubbles are not a problem with this type of injection. (This question relates to step 3f and step 4c shown above)

4. What should I do if I have trouble attaching the needle?

First, be sure you have removed the blue cap. Then, twist the needle onto the syringe until snug. To prevent losing medicine, do not push in the plunger while attaching the needle. (This question relates to step 4a shown above)

5. What should I do if I have trouble removing the needle cover?

With one hand, hold the syringe near the black dashed dose line. With your other hand, hold the needle cover. Pull the needle cover straight off. Do not twist it. (This question relates to step 4f shown above)

6. I am at step 4c. What should I do if the top of the plunger has been pushed past the black dashed dose line?

The black dashed dose line shows the correct dose. If the top of the plunger has been pushed past the line, you should continue from step 4d and take the injection. Before your next injection in 1 week, carefully review the instructions above to help ensure you get the correct dose.

7. When I inject, what should I do if I cannot push the plunger all the way down?

This means the needle has become clogged. Remove the needle from your skin and replace it with the spare needle from your tray. Then choose a different injection site and finish taking the injection.

To review how to:

  • Remove the blue cap of the needle, see step 1d above.
  • Attach the needle, see step 4a above.
  • Remove the needle cover and give the injection, see from step 4f above.
    If you still cannot push the plunger all the way down, remove the needle from your skin. Use a puncture-resistant container to throw away the syringe with the needle still attached. It is important that you then call 1-800-236-9933.

To help prevent a clogged needle, always mix the medicine very well and inject right after mixing.

Where to learn more about Bydureon

  • Talk with your healthcare provider
  • Read the Medication Guide that came with your Bydureon. The Medication Guide can help answer your questions about Bydureon, such as what it is used for, possible side effects, and when to take Bydureon.
  • Enroll in Bydureon Support for FREE ongoing help managing your diabetes. Visit www.Bydureon.com or call 1-800-236-9933.

Instructions for use revised 07/2021

Bydureon (by-DUR-ee-on) Pen

(exenatide extended-release) for injectable suspension

Image showing parts of a Bydureon pen.

Figure A

Before using Bydureon Pen, your healthcare provider should show you how to use it the right way.

Caregivers should help children with mixing and injecting Bydureon.

Read the Instructions for Use before you start using Bydureon Pen and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Getting ready

Bydureon Pen is not for self-injection by people who are blind or cannot see well.

Supplies needed to give your Bydureon Pen injection (not all supplies are included):

  • 1 Bydureon single-use "Pen" tray that contains:
    • 1 Bydureon Pen
    • 1 custom needle
  • a clean flat surface
  • alcohol swab
  • sharps container for throwing away used needles and Pens. See "Properly dispose of your Pen" at the end of these instructions.

Bydureon pen and tray image.

How should I store Bydureon?

  • Store your Bydureon Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Protect pens from light until you are ready to prepare and use your dose.
  • Do not use pens past the expiration date.
  • Do not freeze Bydureon. Do not use Bydureon if it has been frozen.
  • Keep Bydureon in its sealed tray until ready for use.
  • If needed, you can keep your Bydureon Pen out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks.

Keep Bydureon Pen, and all medicines, out of the reach of children.

Step 1: Prepare your Bydureon Pen

Let your Pen come to room temperature.

  • Remove 1 Pen from the refrigerator and let it stand at room temperature for at least 15 minutes.
  • Do not use a pen past its expiration date.

15 minute symbol.

Wash your hands.
Open the tray.

  • Pull up on the corner tab.
  • Remove the Pen and needle.
    • Do not use your Pen or needle if any parts are broken or missing.

Pull corner of tab to open tray.

Check the liquid in your Pen.

  • Check the liquid inside the inspection window. It should be clear and free of particles. Do not use the Pen if the liquid is colored, has particles, or is not clear. Throw it away and get a new one.
    • You may see bubbles in the liquid, this is normal.

Image of inspection window in your Bydureon Pen.

Peel off the paper tab from the needle cover.

Peel off cover from Bydyreon window like this.

Attach the needle to the Pen.

  • Screw the needle onto the Pen by pushing and twisting clockwise until it is tight. Do not remove the needle cover yet.

Screw the needle on to your Bydureon Pen.

Step 2: Mix your dose

Combine the medicine.

  • While holding the pen straight up, slowly turn the knob. Stop when you hear the click and the green label disappears.

Hold the Bydureon Pen upright and slowly turn the knob until you hear a click and the green label disappears.

Firmly tap your Pen to mix.

  • Hold your Pen by the end with the orange label and tap the Pen firmly against the palm of your hand.
    • Do not twist the white knob.
    • Rotate your Pen every 10 taps.
    • You may need to tap your Pen 80 times or more.

Tapping pen - may need to tap more than 80 times.

Check the Bydureon mix.

  • Hold your Pen up to the light and look through both sides of the mixing window. The solution should have no clumps and be uniformly cloudy (see Figure B).

Image showing Bydureon that is not mixed well and has clumps and is mixed well and has no clumps and is a uniform, cloudy solution.

Figure B

  • To get your full dose, Bydureon must be mixed well.
  • If Bydureon is not mixed well, keep tapping your Pen longer and more firmly until it is mixed well.
  • Do not give your Bydureon injection unless your Bydureon is mixed well.

Stop. Do Not proceed unless your medicine is mixed well.

To get your full dose the medicine must be mixed well. If it is not mixed well, tap longer and more firmly.

Check the Bydureon mix again.

  • Compare both sides of the mixing window to the photos below by holding your Pen against the page. Pay attention to the bottom surface. If you do not see clumps you are ready to inject (see Figure C).

Image showing what your Bydureon Pen will look like when it's not mixed properly and what it will look like when it's ready to inject with a place to compare your pen.

Figure C

If you have any questions or are not sure if your Bydureon is mixed well, call 1-800-236-9933 for help.

Step 3: Inject your dose

Important: After the medicine is mixed well, you must inject your dose right away. You cannot save it for later use.

Choose your injection site.

  • The recommended injection sites for Bydureon are your stomach (abdomen), thigh, or back of the arm.
    • Each week you can use the same area of your body but choose a different injection site in that area.
    • Gently wipe the site you choose with an alcohol swab (not included).

Bydureon injection sites on the body include your stomach, thighs and back of your upper arm.

Twist knob to release injection. button.

  • Hold your Pen with the needle pointing straight up and turn the white knob until the orange label disappears and the injection button is released. Do not push the injection button yet.

Hold your Bydureon Pen with the needle pointing straight up and turn the white knob until the orange label disappears and the injection button is released.

Remove the needle cover.

  • Pull the needle cover straight off. Do not twist the needle cover.
    • You may see a few drops of liquid on the needle or in the cover.

Pull the needle cover straight off your Bydureon Pen. Do not twist the needle cover.

Inject your Bydureon.

  • Insert the needle into your skin.
  • Press the injection button with your thumb until you hear a “click”. Keep holding the button down and slowly count to 10 to get your full dose.

Insert the Bydureon needle into your skin and press the injection button with your thumb until a click is heard then count to 10 to make sure the full dose is delivered.

Properly dispose of your used Pen.

• Put your used needles and Pens in an FDAcleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and Pens in your household trash. See Common Questions and Answers for additional disposal information.

Sharps container.

Common Questions and Answers for your Bydureon Pen

1. How do I know that the Bydureon is mixed well?

The Bydureon is mixed well when the liquid looks cloudy from both sides of the window. You should not see any clumps in the liquid. It may help to hold your Pen up to the light to see in the window. If you see clumps of any size keep tapping your Pen firmly against the palm of your hand until mixed.

2. I am having trouble mixing my dose. What should I do?

Remember, before preparing your dose, leave your Pen out of the refrigerator for at least 15 minutes. This will let your Pen warm up to room temperature. It will be easier to mix Bydureon if your Pen is at room temperature.

Be sure you are holding your Pen at the end with the knob and the orange label. This will help you grip your Pen better and tap it more firmly against your palm.

It may also help to tap the mixing window on both sides against your palm. If you see any clumps, keep tapping.

3. After I mix Bydureon, how long can I wait before taking the injection?

You must inject your dose of Bydureon right after mixing it. If you do not inject your Bydureon right away, small clumps of medicine may form in your Pen and you may not get your full dose.

4. I am ready to inject my dose. What should I do if I see air bubbles in the Pen?

It is normal for air bubbles to be in your Pen. Bydureon is injected into your skin (subcutaneously). Air bubbles will not harm you or affect your dose with this type of injection.

5. What should I do if I cannot push the injection button all the way in when trying to inject my dose?

Check that you have fully screwed on the pen needle. Also be sure you twisted the knob until it stopped, the orange label disappeared, and the injection button appears.

If you still cannot push the button in, this may mean that the needle is clogged. Remove the needle from your skin and replace it with the spare needle from the carton. Review how to attach the needle. Then choose a different injection site and finish taking the injection.

If you still cannot push the button all the way in, remove the needle from your skin. Use a puncture-resistant container to throw away the pen with the needle still attached.

If you have problems giving your Bydureon Pen injection or have any questions call 1-800-236-9933 for more instructions.

6. How do I know if I injected my full dose?

To be sure you get your full dose, press the injection button with your thumb until you hear a "click". After the "click", continue to hold the needle in your skin for 10 seconds. This will allow enough time for you to get your full dose.

7. What if I do not have an FDA-cleared sharps disposal container?

Do not throw away (dispose of) loose needles and Pens in your household trash.

  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without. sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
      When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and Pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal

Instructions for use revised 07/2021.

Source: Food and Drug Administration (FDA). Last updated June 10, 2022.