BYDUREON (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

BYDUREON (exenatide extended-release for injectable suspension) for once every seven days (weekly) subcutaneous administration is supplied in cartons of 4 single-dose trays for use (NDC 66780-219-04).

Each single-dose tray contains:

  • One vial containing 2 mg exenatide (as a white to off-white powder)
  • One prefilled syringe delivering 0.65 mL diluent
  • One vial connector
  • Two custom needles (23G, 5/16″) specific to this delivery system (one is a spare needle)

Do not substitute needles or any other components in the tray.

16.2 Storage and Handling

  • BYDUREON should be stored in the refrigerator at 36˚Fto 46˚F (2˚C to 8˚C), up to the expiration date or until preparing for use. BYDUREON should not be used past the expiration date. The expiration date can be found on the carton and the cover of the single-dose tray.
  • Do not freeze the BYDUREON tray. Do not use BYDUREON if it has been frozen. Protect from light.
  • Each single-dose tray can be kept at room temperature not to exceed 77°F (25˚C) [see USP Controlled Room Temperature] for no more than a total of 4 weeks, if needed.
  • Use the diluent only if it is clear and free of particulate matter.
  • After suspension, the mixture should be white to off-white and cloudy.
  • BYDUREON must be administered immediately after the exenatide powder is suspended in the diluent and transferred to the syringe.
  • Use a puncture-resistant container to discard the syringe with the needle still attached. Do not reuse or share needles or syringes.
  • Keep out of the reach of children.

17 PATIENT COUNSELING INFORMATION

Inform patients about the potential risks and benefits of BYDUREON and of alternative modes of therapy. Also inform patients about the importance of diabetes self-management practices, such as regular physical activity, adhering to meal planning, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications.

17.1 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 is unknown. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia or dyspnea) [see Warnings and Precautions (5.1)].

17.2 Risk of Pancreatitis

Inform patients treated with BYDUREON of the potential risk for pancreatitis. Explain that persistent severe abdominal pain that may radiate to the back and which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to promptly discontinue BYDUREON and contact their healthcare provider if persistent severe abdominal pain occurs [see Warnings and Precautions (5.2)].

17.3 Risk of Hypoglycemia

The risk of hypoglycemia is increased when BYDUREON is used in combination with an agent that induces hypoglycemia, such as a sulfonylurea [see Warnings and Precautions (5.3)]. Explain the symptoms, treatment, and conditions that predispose to the development of hypoglycemia. While the patient’s usual instructions for hypoglycemia management do not need to be changed, these instructions should be reviewed and reinforced when initiating BYDUREON therapy, particularly when concomitantly administered with a sulfonylurea [see Warnings and Precautions (5.3)].

17.4 Risk of Renal Impairment

Inform patients treated with BYDUREON of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs [see Warnings and Precautions (5.4)].

17.5 Risk of Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of exenatide. If symptoms of hypersensitivity reactions occur, patients must stop taking BYDUREON and seek medical advice promptly [see Warnings and Precautions (5.7)].

17.6 Use in Pregnancy

Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant [see Use in Specific Populations (8.1)].

17.7 Instructions

Each dose of BYDUREON should be administered as a subcutaneous injection at any time on the dosing day, with or without meals. Patients should be informed that the day of once every seven days (weekly) administration can be changed if necessary as long as the last dose was administered 3 or more days before. If a dose is missed, it should be administered as soon as noticed, provided the next regularly scheduled dose is due at least three days later. Thereafter, patients can resume their usual once every seven days (weekly) dosing schedule. If a dose is missed and the next regularly scheduled dose is due in one or two days, the patient should not administer the missed dose and instead resume BYDUREON with the next regularly scheduled dose. [see Dosage and Administration (2.1)].

Counsel patients that they should never share a BYDUREON single-dose tray with another person, even if the needle is changed. Sharing of the single-dose trays or needles between patients may pose a risk of transmission of infection.

If a patient is currently taking BYETTA, it should be discontinued upon starting BYDUREON. Patients formerly on BYETTA who start BYDUREON may experience transient elevations in blood glucose concentrations, which generally improve within the first two weeks after initiation of therapy [see Dosage and Administration (2.3) and Clinical Studies (14.2) ].

Treatment with BYDUREON may also result in nausea, particularly upon initiation of therapy [see Adverse Reactions (6)].

Inform patients about the importance of proper storage of BYDUREON, injection technique, and dosing [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)].

The patient should read the BYDUREON Medication Guide and the Instructions for Use before starting BYDUREON therapy and review them each time the prescription is refilled.

Manufactured by Amylin Pharmaceuticals, Inc., San Diego, CA 92121

1-877-700-7365

http://www.bydureon.com

Literature Revised January 2012

BYDUREON is a trademark of Amylin Pharmaceuticals, Inc.

U.S. Patent Nos. 5,424,286, 6,858,576, 6,872,700, 6,956,026, 7,456,254, 6,479,065, 6,495,164, 6,667,061, 6,824,822, 7,223,440, 7,563,871 and 7,612,176.

© 2012 Amylin Pharmaceuticals, Inc. All rights reserved.
832001-JJ

Medication Guide
BYDUREON™ (by-DUR-ee-on)
(exenatide extended-release
for injectable suspension)

Read this Medication Guide and Instructions for Use before you start using BYDUREON and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have questions about BYDUREON after reading this information, ask your healthcare provider or pharmacist.

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

Serious side effects may happen in people who take BYDUREON, including:

1.
Possible thyroid tumors, including cancer. During the drug testing process, the medicine in BYDUREON caused rats to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if BYDUREON will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people.
  • Before you start taking BYDUREON, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2. Do not take BYDUREON if you or any of your family members have medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not take BYDUREON.
  • While taking BYDUREON, 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.
2.
Inflammation of the pancreas (pancreatitis), which may be severe and lead to death.
Before taking BYDUREON, tell your healthcare provider if you have had:

  • pancreatitis
  • stones in your gallbladder (gallstones)
  • a history of alcoholism
  • high blood triglyceride levels
These medical conditions can make you more likely to get pancreatitis. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking BYDUREON.

Stop taking BYDUREON and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.

What is BYDUREON?

  • 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 a long-acting form of the medication contained in BYETTA. Do not use BYDUREON and BYETTA together.
  • BYDUREON is not recommended as the first choice of medication for treating diabetes.
  • BYDUREON is not insulin.
  • It is not known if BYDUREON is safe and effective when used with insulin.
  • BYDUREON is not for use in people with type 1 diabetes or people with a condition caused by very high blood sugar (diabetic ketoacidosis).
  • It is not known if BYDUREON is safe and effective in children. BYDUREON is not recommended for use in children.
  • It is not known if BYDUREON is safe and effective in people who have a history of pancreatitis.
  • BYDUREON has not been studied in people who have severe kidney problems.

Who should not use BYDUREON?

Do not use BYDUREON if:

  • you or any of your family members have a history of medullary thyroid cancer.
  • you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body.
  • you are allergic to exenatide or any of the ingredients in BYDUREON. See the end of this Medication Guide for a complete list of ingredients in BYDUREON. Symptoms of a severe allergic reaction may include:
    • swelling of your face, lips, tongue, or throat
    • problems breathing or swallowing
    • severe rash or itching
    • fainting or feeling dizzy
    • very rapid heartbeat

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

What should I tell my healthcare provider before using BYDUREON?

Before using BYDUREON, tell your healthcare provider if you:

  • have any of the conditions listed in the section “What is the most important information I should know about BYDUREON?”
  • have severe problems with your stomach such as slow emptying of your stomach (gastroparesis) or problems digesting food.
  • have or have had kidney problems, or have had a kidney transplant.
  • have any other medical conditions.
  • are pregnant or are planning to become pregnant. It is not known if BYDUREON may harm your unborn baby. Tell your healthcare provider if you become pregnant while taking BYDUREON.
  • Pregnancy Registry: Amylin Pharmaceuticals, Inc. has a registry for women who take BYDUREON during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you take BYDUREON at any time during pregnancy, you may enroll in this registry by calling 1-800-633-9081.
  • are breastfeeding or plan to breastfeed. It is not known if BYDUREON passes into your breast milk. You and your healthcare provider should decide if you will take BYDUREON or breastfeed. You should not do both without talking with your healthcare provider first.

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

Especially tell your healthcare provider if you take:

  • other diabetes medicines, especially insulin or a sulfonylurea
  • any medicine taken by mouth
  • warfarin sodium (Coumadin® , Jantoven®)

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

How should I use BYDUREON?

For detailed instructions, see the Instructions for Use that comes with your BYDUREON.

  • Use BYDUREON exactly as your healthcare provider tells you to.
  • BYDUREON is injected once every seven days (weekly) any time during the day.
  • BYDUREON is a subcutaneous injection. Inject BYDUREON into your skin exactly the way your healthcare provider told you to. You can take the injection 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 be sure to choose a different injection site in that area.
  • You can take BYDUREON with or without food.
  • If you miss a dose of BYDUREON, it should be taken as soon as you remember, provided the next regularly scheduled dose is due at least three days later.
  • If you miss a dose of BYDUREON and the next regularly scheduled dose is due one or two days later, do not take the missed dose but take BYDUREON on the next regularly scheduled day.
  • Do not take 2 doses of BYDUREON less than 3 days apart.
  • If you want to change your dosing day, you can. Your new dosing day must be at least 3 days after your last dose.
  • Your healthcare provider must teach you how to inject BYDUREON before you use it for the first time. If you have any questions or do not understand the instructions, talk with your healthcare provider or pharmacist.
  • BYDUREON must be injected right after you mix it.
  • If you are taking BYETTA and your healthcare provider prescribed BYDUREON, you should follow your healthcare provider’s instructions about when to stop taking BYETTA and when to start taking BYDUREON. BYETTA is a different form of the same medicine that is in BYDUREON, so do not take BYETTA when you are taking BYDUREON. When you first change from BYETTA to BYDUREON, your blood sugar levels may be higher than usual and should get better in about 2 weeks.
  • Inject your dose of BYDUREON under the skin (subcutaneous injection), as you are told to by your healthcare provider. Do not inject BYDUREON into a vein or muscle.
  • Do not share your BYDUREON tray with another person even if the needle is changed. Sharing your tray with another person can cause you or someone else to get an infection.
  • Follow your healthcare provider’s instructions for diet, exercise, how often to test your blood sugar, and when to get your HbA1c checked. If you see your blood sugar increasing during treatment with BYDUREON, talk to your healthcare provider because you may need to adjust your current treatment plan for your diabetes.
  • Talk to your healthcare provider about how to manage high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia), and how to recognize problems that can happen with your diabetes.

What are the possible side effects of BYDUREON?

BYDUREON can cause serious side effects, including:

  • See “What is the most important information I should know about BYDUREON?”
  • Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while you use BYDUREON. Signs and symptoms of low blood sugar may include:
    • shakiness
    • sweating
    • headache
    • drowsiness
    • weakness
    • dizziness
    • confusion
    • irritability
    • hunger
    • fast heartbeat
    • feeling jittery

Talk with your healthcare provider about how to recognize and treat low blood sugar. Make sure that your family and other people around you a lot know how to recognize and treat low blood sugar.

  • Kidney problems (kidney failure). BYDUREON may cause nausea, vomiting or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure, which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away, or if you cannot drink liquids by mouth.
  • Severe allergic reactions. Severe allergic reactions can happen with BYDUREON. Stop taking BYDUREON, and get medical help right away if you have any symptom of a severe allergic reaction. See “Who should not take BYDUREON?”

The most common side effects of BYDUREON 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 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.

How should I store BYDUREON?

  • Store BYDUREON in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Do not use BYDUREON past the expiration date. The expiration date is labeled EXP and can be found on the paper cover of the single-dose tray.
  • Do not freeze BYDUREON trays. Do not use BYDUREON if it has been frozen.
  • Protect BYDUREON from light until you are ready to prepare and use your dose.
  • 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.
  • See the Instructions for Use for information about how to throw away your used BYDUREON parts.

Keep BYDUREON, and all medicines, out of the reach of children.

General information about 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.

This Medication Guide summarizes the most important information about BYDUREON. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about BYDUREON that is written for healthcare professionals.

For more information about BYDUREON, go to www.BYDUREON.com or call 1-877-700-7365.

What are the ingredients in BYDUREON?

Contents of vial:

Active ingredient: exenatide

Inactive ingredients: polylactide-co-glycolide and sucrose.

Contents of liquid (diluent) in syringe:

Inactive ingredients: carboxymethylcellulose sodium, polysorbate 20, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, water for injection.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: January 2012

Manufactured by Amylin Pharmaceuticals, Inc., San Diego, CA 92121.

BYDUREON is a trademark and BYETTA is a registered trademark of Amylin Pharmaceuticals, Inc. All other marks are the marks of their respective owners.

© 2012 Amylin Pharmaceuticals, Inc.

All rights reserved.

833001-FF

logo

Instructions for Use

Read the BYDUREON Medication Guide for important safety information.

Your Step-by-Step Guide

CAUTION: Keep guide and medicine out of the reach of children.

If you have questions about taking BYDUREON™(exenatide extended-release for injectable suspension)

  • Refer to the Common Questions and Answers on pages 32 to 36
  • Call 1- 877-700-7365
  • Visit www.BYDUREON.com
IMPORTANT:
Read this Instructions for Use before you start using BYDUREON 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.

Consider marking your calendar to remind yourself to take your injection once every seven days (weekly).

Your guide to the parts

  • Single-dose tray
figure: single dose tray
(click image for full-size original)

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

figure: parts guide
(click image for full-size original)

Your guide to the parts

figure: single dose tray contents
(click image for full-size original)

What’s 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:

1
Getting Started
2
Connecting the Parts
3
Mixing the Medicine and Filling the Syringe
4
Injecting the Medicine
?
For Common Questions and Answers, see page 32.

How to store your single-dose trays of BYDUREON

  • Store your BYDUREON 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

Helpful Hints
  • Try to be patient. It can take time to get used to giving yourself injections
  • Set aside enough time to complete all the steps without stopping
  • As you do the steps, it can be helpful to read the directions aloud
1a
Take a single-dose tray from the refrigerator. You will also need a puncture-resistant container with a lid to hold used needles and syringes. This is not included in the tray. You may use a red biohazard container, a hard plastic container (such as an empty detergent bottle), or a metal container (such as an empty coffee can). Ask your healthcare provider how to safely throw away used needles and the container. There may be state and local laws about this. Do not throw the container in your household trash or try to recycle it.
1b
Wash your hands. Prepare to clean your injection site with soap and water or an alcohol swab prior to injecting your medicine.
figure: peel back cover

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.

fig1d

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.

fig1e

Pick up the vial.

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

fig1f

Use your thumb to remove the green cap.

Put the vial aside.

2 Connecting the Parts

fig2a

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

fig2b

Hold the vial connector package.

In your other hand, hold the vial.

fig2c

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

fig2d

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

fig2e

This is what the vial should now look like.

Put it aside for later.

fig2f

Pick up the syringe.

With your other hand, firmly grasp the 2 gray squares on the white cap.

fig2g

Break off the cap.

Be careful not to push in the plunger.

figure: break off cap

Just like you might break a stick, you are breaking off the cap.

fig2h

This is what the broken-off cap looks like.

You will not be using the cap and can throw it away.

fig2i

This is what the syringe should now look like.

fig2j

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 overtighten.

fig2k

This is how the parts should now look when they are connected.

figure: parts

3 Mixing the Medicine and Filling the Syringe

IMPORTANT:
During these next steps, you will be mixing the medicine and filling the syringe. Once you mix the medicine, you must inject it. You cannot save the mixed medicine to inject at a later time.
fig 3a

With your thumb, push down the plunger until it stops.

The plunger may feel like it is springing back a little.

figure: push down

For steps 3a to 3f, keep pushing down on the plunger with your thumb.

fig3b

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 hard like you would shake a bottle of oil-and-vinegar salad dressing.

figure: shake hardfig3c

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

fig3d

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.

fig3e

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

fig3f

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.

fig3g

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.

fig3h

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

fig3i

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

Be careful not to push in the plunger.

fig3j

This is what the syringe should now look like.

4 Injecting the Medicine

fig4a

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.
fig4b

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.

figure: top of plungerfig4c

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.
fig4d

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 be sure to choose a different injection site in that area. Clean the injection site prior to injecting the medicine (with soap and water or an alcohol swab).

fig4e

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

fig4f

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.

fig4g

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.

fig4h

Use the puncture-resistant container to throw away the syringe with the needle still attached. To avoid a needlestick injury, do not put the cover back on the needle.

Throw away all other parts in the trash. You do not have to save them. Each single-dose tray has a new supply of parts to use for your next dose of BYDUREON.

Please keep this Instructions for Use for your next dose.

Common Questions and Answers

If your question is about: If your question is about:
How soon to inject after mixing 1
Mixing the medicine 2
Air bubbles in syringe 3
Attaching the needle 4
Removing the needle cover 5
Plunger not lining up with black dashed Dose Line 6
Being unable to push the plunger down when injecting 7
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 on pages 18 through 20.)
3.
I”m 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 shown on page 21 and step 4c shown on page 27.).
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 on page 25.)
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 on page 29.)
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 on pages 17 through 31.
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 page 9
  • Attach the needle, see page 25
  • Remove the needle cover and give the injection, see pages 29 and 30

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 1-877-700-7365.
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 1-877-700-7365.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: January 2012

BYDUREON ™ is a trademark of Amylin Pharmaceuticals, Inc. © 2012 Amylin Pharmaceuticals, Inc. All rights reserved.
935001-FF

PRINCIPAL DISPLAY PANEL — 2 mg Vial Carton

NDC 66780-219-04
Rx Only

Once-weekly
Bydureon™

exenatide extended-release
for injectable suspension

2 mg/vial

Subcutaneous use only.

Dispense the enclosed Medication Guide to each patient.

Total quantity: 4 single-dose trays

Each tray includes supplies to deliver a 2 mg dose.

Use 1 tray every week.

Store refrigerated: 36°F to 46°F (2°C to 8°C). Do not freeze.

Not a child-resistant container.

Keep out of reach of children.

Principal Display Panel -- 2 mg Vial Carton
(click image for full-size original)
BYDUREON exenatide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66780-219
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66780-219-04 4 TRAY (TRAY) in 1 CARTON contains a TRAY
1 1 KIT (KIT) in 1 TRAY This package is contained within the CARTON (66780-219-04)
2 NDC:66780-219-02 1 TRAY (TRAY) in 1 CARTON contains a TRAY
2 1 KIT (KIT) in 1 TRAY This package is contained within the CARTON (66780-219-02)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 0.65 mL
Part 2 1 SYRINGE, GLASS 0.65 mL
Part 1 of 2
BYDUREON exenatide injection, powder, for suspension
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
exenatide (exenatide) exenatide 2 mg in 0.65 mL
Inactive Ingredients
Ingredient Name Strength
poly(dl-lactic-co-glycolic acid), (50:50; 63000 mw)
sucrose
Packaging
# Item Code Package Description Multilevel Packaging
1 0.65 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022200 01/27/2012
Part 2 of 2
DILUENT diluent injection, solution
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
carboxymethylcellulose sodium
sodium chloride
polysorbate 20
sodium phosphate, monobasic, monohydrate
sodium phosphate, dibasic, heptahydrate
water
Packaging
# Item Code Package Description Multilevel Packaging
1 0.65 mL in 1 SYRINGE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022200 01/27/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022200 01/27/2012
Labeler — Amylin Pharmaceuticals, Inc. (196877526)

Revised: 01/2012 Amylin Pharmaceuticals, Inc.

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