BYETTA is supplied as a sterile solution for subcutaneous injection containing 250 mcg/mL exenatide in the following packages:

• 5 mcg per dose, 60 doses, 1.2 mL prefilled pen
• 10 mcg per dose, 60 doses, 2.4 mL prefilled pen

In a clinical study of BYETTA, three patients with type 2 diabetes each experienced a single overdose of 100 mcg SC (10 times the maximum recommended dose). Effects of the overdoses included severe nausea, severe vomiting, and rapidly declining blood glucose concentrations. One of the three patients experienced severe hypoglycemia requiring parenteral glucose administration. The three patients recovered without complication. In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.

BYETTA (exenatide) is a synthetic peptide that was originally identified in the lizard Heloderma suspectum. Exenatide differs in chemical structure and pharmacological action from insulin, sulfonylureas (including D-phenylalanine derivatives and meglitinides), biguanides, thiazolidinediones, alpha-glucosidase inhibitors, amylinomimetics and dipeptidyl peptidase-4 inhibitors.

Exenatide is a 39-amino acid peptide amide. Exenatide has the empirical formula C184H282N50O60S and molecular weight of 4186.6 Daltons. The amino acid sequence for exenatide is shown below.

H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2

BYETTA is supplied for SC injection as a sterile, preserved isotonic solution in a glass cartridge that has been assembled in a pen-injector (pen). Each milliliter (mL) contains 250 micrograms (mcg) synthetic exenatide, 2.2 mg metacresol as an antimicrobial preservative, mannitol as a tonicity-adjusting agent, and glacial acetic acid and sodium acetate trihydrate in water for injection as a buffering solution at pH 4.5. Two prefilled pens are available to deliver unit doses of 5 mcg or 10 mcg. Each prefilled pen will deliver 60 doses to provide for 30 days of twice daily administration (BID).

BYETTA has been studied as monotherapy and in combination with metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, a combination of metformin and a thiazolidinedione, or in combination with insulin glargine with or without metformin and/or thiazolidinedione.

Patients should be advised that BYETTA pens are never to be shared with another patient.

Patients should be informed of the potential risks and benefits of BYETTA and of alternative modes of therapy. Patients should also be fully informed about self-management practices, including the importance of proper storage of BYETTA, injection technique, timing of dosage of BYETTA and concomitant oral drugs, adherence to meal planning, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications.

Manufactured for Amylin Pharmaceuticals, Inc., San Diego, CA 92121
1-800-868-1190

http://www.BYETTA.com

This product and its use are covered by US Patent Nos. 5,424,286, 6,858,576, 6,872,700, 6,902,744, 6,956,026, 7,297,761, 7,521,423, 7,741,269, and other patents pending.

Literature Revised December 2011

BYETTA is a registered trademark of Amylin Pharmaceuticals, Inc.

© 2005, 2011 Amylin Pharmaceuticals, Inc. All rights reserved.
822017-AA

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

Medication Guide

BYETTA® (bye-A-tuh)
(exenatide)
Injection

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

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

Serious side effects can happen in people who take BYETTA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death.

Before taking BYETTA, 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 in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking BYETTA.

While taking BYETTA:

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. These may be symptoms of pancreatitis.

What is BYETTA?

• BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program.
• BYETTA is not insulin.
• You should not take BYETTA instead of insulin.
• The use of BYETTA with short acting insulin is not recommended.
• The use of BYETTA with rapid acting insulin is not recommended.
• BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.
• It is not known if BYETTA is safe and effective in children.
• BYETTA has not been studied in people who have pancreatitis.
• BYETTA should not be used in people who have severe kidney problems.

Who should not use BYETTA?

Do not use BYETTA if:

• you have had an allergic reaction to exenatide or any of the other ingredients in BYETTA. See the end of this Medication Guide for a complete list of ingredients in BYETTA.

Symptoms of a severe allergic reaction with BYETTA may include:

What should I tell my healthcare provider before using BYETTA?

Before taking BYETTA, tell your healthcare provider if you:

• have or have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels.
• have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
• have or have had kidney problems, or have had a kidney transplant.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if BYETTA will harm your unborn baby.

   

  Pregnancy Registry: Amylin Pharmaceuticals, Inc. has a registry for women who take BYETTA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you take BYETTA at any time during pregnancy you may enroll in this registry by calling (800) 633-9081.

• are breastfeeding or plan to breast-feed. It is not known if BYETTA passes into your breast milk. You and your healthcare provider should decide if you will take BYETTA or breast-feed. You should not do both without talking with your healthcare provider first.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. BYETTA slows stomach emptying and can affect medicines that need to pass through the stomach quickly. BYETTA may affect the way some medicines work and some other medicines may affect the way BYETTA works.

Especially tell your healthcare provider if you take:

• Other anti-diabetes medicines, especially sulfonylurea medicines or insulin.
• birth control pills that are taken by mouth (oral contraceptives). BYETTA may lower the amount of the medicine in your blood from your birth control pills and they may not work as well to prevent pregnancy. Take your birth control pills at least one hour before your injection of BYETTA. If you must take your birth control pills with food, take it with a meal or snack where you do not also take BYETTA.
• an antibiotic. Take antibiotic medicines at least one hour before taking BYETTA. If you must take your antibiotic with food, take it with a meal or snack where you do not also take BYETTA.
• warfarin sodium (Coumadin®, Jantoven®).
• a blood pressure medicine.
• a water pill (diuretic).
• a pain medicine.
• lovastatin (Altoprev®, Mevacor®, Advicor®).

Ask your healthcare provider if you are not sure if your medicine is listed above.

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

How should I use BYETTA?

See the Pen User Manual that comes with BYETTA for instructions for using the BYETTA Pen and injecting BYETTA.

• Your healthcare provider may prescribe BYETTA alone or with certain other medicines to help control your blood sugar.
• BYETTA comes in a prefilled pen.
• Use BYETTA exactly as prescribed by your healthcare provider. Do not change your dose unless your healthcare provider has told you to change your dose.
• Your healthcare provider must teach you how to inject BYETTA before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider or pharmacist.
• Pen needles are not included. You may need a prescription to purchase pen needles from your pharmacist. Ask your healthcare provider which needle length and gauge is best for you.
• Inject your dose of BYETTA under the skin (subcutaneous injection) of your upper leg (thigh), stomach area (abdomen), or upper arm as instructed by your healthcare provider. Do not inject into a vein or muscle.
• Do not mix BYETTA and insulin in the same syringe or vial even if you take them at the same time.
• BYETTA is injected two times each day, at any time within the 60 minutes (1 hour) before your morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). Do not take BYETTA after your meal.
• If you miss a dose of BYETTA, skip that dose and take your next dose at the next prescribed time. Do not take an extra dose or increase the amount of your next dose to make up for a missed dose.
• If you use too much BYETTA, call your healthcare provider or poison control center right away. Too much BYETTA can cause your blood sugar to drop quickly and you may have symptoms of low blood sugar. You may need medical treatment right away. Too much BYETTA can also cause severe nausea and vomiting.
• Follow your healthcare provider's instructions for diet, exercise, and how often to test your blood sugar. If you see your blood sugar increasing during treatment with BYETTA, 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.
• Never share your BYETTA pen with another person. You may give an infection to them, or get an infection from them, and BYETTA may harm them.

What are the possible side effects of BYETTA?

BYETTA can cause serious side effects.

See "What is the most important information I should know about BYETTA?"

It is not known whether BYETTA, or other anti-diabetes medications, increase your risk of a heart attack or stroke.

• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take BYETTA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea or insulin medicine may need to be lowered while you use BYETTA. Signs and symptoms of low blood sugar may include:

  headache drowsiness weakness dizziness confusion

  irritability hunger fast heart beat sweating feeling jittery

Talk with your healthcare provider about how to treat low blood sugar.

• Kidney problems. BYETTA may cause new or worse problems with kidney function, including kidney failure. Dialysis or kidney transplant may be needed.
  • While taking BYETTA:
    Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away, or if you cannot take liquids by mouth. You may be at increased risk for kidney problems.
• Severe allergic reactions. Severe allergic reactions can happen with BYETTA. Stop taking BYETTA, and get medical help right away if you have any symptom of a severe allergic reaction. See "Who should not take BYETTA?"

The most common side effects with BYETTA include:

• nausea. Nausea most commonly happens when first starting BYETTA, but may become less over time.
• vomiting.
• diarrhea.
• feeling jittery.
• dizziness.
• headache.
• acid stomach.
• constipation.
• weakness.

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

These are not all the side effects with BYETTA.

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 BYETTA?

• Store your new, unused BYETTA Pen in the original carton in a refrigerator at 36°F to 46°F (2°C to 8ºC).
• After first use, keep your BYETTA Pen at a temperature cooler than 77°F (25°C).
• Do not freeze your BYETTA Pen. Do not use BYETTA if it has been frozen.
• Protect BYETTA from light.
• Use a BYETTA Pen for only 30 days. Throw away a used BYETTA Pen after 30 days, even if there is some medicine left in the pen.
• Do not use BYETTA after the expiration date printed on the label.
• Do not store the BYETTA Pen with the needle attached. If the needle is left on, medicine may leak from the BYETTA Pen or air bubbles may form in the cartridge.
• See the BYETTA Pen User Manual for instructions about the right way to throw away your BYETTA Pen.
• Keep your BYETTA Pen, pen needles, and all medicines out of the reach of children.

General information about BYETTA

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

This Medication Guide includes the most important information you should know about using BYETTA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about BYETTA that is written for health professionals.

For more information about BYETTA, go to http://www.BYETTA.com or call BYETTA Customer Service at 1-800-868-1190.

What are the ingredients in BYETTA?

Active Ingredient: exenatide

Inactive Ingredients: metacresol, mannitol, glacial acetic acid, and sodium acetate trihydrate in water for injection.

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

Revised December 2011

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

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

© 2005, 2011 Amylin Pharmaceuticals, Inc. All rights reserved. 823015-AA

5 mcg PEN USER MANUAL

Section 1
 
Read this section completely before you begin. Then, move on to Section 2–Getting Started.

WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN

PEN USER MANUAL

Read these instructions carefully BEFORE using your BYETTA Pen. For complete dosing and safety information, also read the BYETTA Medication Guide that comes with the BYETTA Pen carton.

It is important that you use your pen correctly. Failure to follow these instructions completely may result in a wrong dose, a broken pen or an infection.

These instructions do not take the place of talking with your healthcare provider about your medical condition or your treatment. If you are having problems using your BYETTA Pen, call toll free 800-868-1190.

IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN

• Each BYETTA Pen contains enough medicine for injection two times each day for 30 days. You do not have to measure any doses, the pen measures each dose for you.
• Do not transfer the medicine in the BYETTA Pen to a syringe or vial.
• Do not mix BYETTA and insulin in the same syringe or vial even if you take them at the same time.
• If any part of your pen appears broken or damaged, do not use the pen.
• This BYETTA Pen is not recommended for use by people who are blind or have vision problems without the help of a person trained in the proper use of the pen.
• Follow the injection method explained to you by your healthcare provider.
• Follow Section 2 only to set up a new pen before first use.
• Section 3 of this manual should be used for every injection.

ABOUT PEN NEEDLES

What kinds of needles can be used with my BYETTA Pen?

• Pen needles are not included with your pen. You may need a prescription to get them from your pharmacist.
• Use 29 (thin), 30, or 31 (thinner) gauge disposable pen needles with your BYETTA Pen. Ask your healthcare provider which needle gauge and length is best for you.

Do I use a new needle for each injection?

• Yes. Do not reuse needles.
• Remove the needle from the pen immediately after you complete each injection. This will help prevent leakage of BYETTA, keep out air bubbles, reduce needle clogs, and decrease the risk of infection.
• Do not push the injection button on your pen unless a needle is attached to the pen.

How do I throw away my needles?

• Do not throw away the pen with a needle attached.
• Place used needles in a closeable, puncture-resistant container. You may use a sharps container (such as a red biohazard container), a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). Ask your healthcare provider for instructions on the right way to throw away (dispose of) your used pens and the container. There may be state and local laws about how you should throw away used pens and needles.
• Do not throw the disposal container in the household trash. Do not recycle.
• Always keep the puncture-proof container out of reach of children.

Never share your BYETTA pen or needles with another person. You may give an infection to them, or get an infection from them, and BYETTA may harm them.

STORING YOUR BYETTA PEN

How do I store my BYETTA Pen?

• Prior to first use, store your unused BYETTA Pen in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C).
• After first use, your BYETTA Pen can be kept at a temperature not to exceed 77°F (25°C).
• Do not freeze. Do not use BYETTA if it has been frozen. BYETTA should be protected from light.
• When carrying the pen away from home, store the pen at a temperature between 36°F to 77°F (2°C to 25°C) and keep dry.
• Do not store the pen with the needle attached. If the needle is left on the pen, BYETTA may leak from the pen and air bubbles may form in the cartridge.

Keep your pen and needles out of the reach of children.

How long can I use a BYETTA Pen?

• You can use your BYETTA Pen for up to 30 days after setting up a new pen for first use. After 30 days, throw away the BYETTA Pen, even if it is not completely empty.
• Mark the date when you first used your pen and the date 30 days later in the spaces below:

Date of First Use                      Date to Throw Away Pen                 

• BYETTA should not be used after the expiration date printed on the pen label.

How do I clean my BYETTA Pen?

• Wipe the outside of the pen with a clean, damp cloth.
• White particles may appear on the outside tip of the cartridge during normal use. You may remove them with an alcohol wipe or alcohol swab.

See the complete BYETTA Medication Guide
that comes with BYETTA. For more information,
call toll free 800-868-1190 or visit www.BYETTA.com

Section 2
 
Read and follow the directions in this section only after you've read Section 1—What You Need To Know About Your BYETTA Pen.

GETTING STARTED

Set up your new pen just before you use it the first time. For routine use, do not repeat this one-time-only new pen setup. If you do, you will run out of BYETTA before 30 days of use.

ONE-TIME-ONLY NEW PEN SETUP
STEP A Check the Pen
		Note: A small air bubble in the cartridge is normal.
Wash hands prior to use. Check pen label to make sure it is your 5 mcg pen. Pull off the blue pen cap.	Check BYETTA in the cartridge. The liquid should be clear, colorless, and free of particles. If not, do not use.
STEP B Attach the Needle
Remove paper tab from outer needle shield. Push outer needle shield containing the needle straight onto the pen, then screw needle on until secure.	Pull off outer needle shield. Do not throw away.	Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal.
STEP C Dial the Dose
Check that the is in the dose window. If not, turn dose knob away from you (clockwise) until it stops and the is in the dose window.	Pull dose knob out until it stops and the is in the dose window.	Turn dose knob away from you until it stops at . Make sure that the 5 with the line under it is in the center of the dose window.
Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in Section 4 of this user manual.
STEP D Prepare the Pen
Point the needle of the pen up and away from you.	PUSH & HOLD Use thumb to firmly push injection button in until it stops, then continue holding the injection button in while slowly counting to 5. If you do not see a stream or several drops come from the needle tip, repeat Steps C & D.	Pen preparation is complete when the is in the center of the dose window AND you have seen a stream or several drops come from the needle tip.
Note: If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of this user manual.
STEP E Complete New Pen Setup
Turn dose knob away from you until it stops and the is in the dose window.	For routine use, do not repeat this one-time-only new pen setup. If you do, you will run out of BYETTA before 30 days of use.	You are now ready for your first dose of BYETTA. Go to Section 3, Step 3, for instructions on how to inject your first routine dose.
Note: If you cannot turn the dose knob, see Commonly Asked Questions, number 7, in Section 4 of user manual.

Section 3
Now that you have done the one-time-only new pen setup, follow Section 3 for all of your injections.
ROUTINE USE
STEP 1 Check the Pen
Wash hands prior to use. Check pen label to make sure it is your 5 mcg pen. Pull off the blue pen cap.	Check BYETTA in the cartridge. The liquid should be clear, colorless, and free of particles. If it is not, do not use.	Note: A small air bubble will not harm you or affect your dose.
STEP 2 Attach the Needle
Remove paper tab from outer needle shield. Push outer needle shield containing the needle straight onto pen, then screw needle on until secure.	Pull off outer needle shield. Do not throw away.	Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal.
STEP 3 Dial the Dose
Check that the is in the dose window. If not, turn dose knob away from you (clockwise) until it stops and the is in the dose window.	Pull dose knob out until it stops and the is in the dose window.	Turn dose knob away from you until it stops at . Make sure that the 5 with the line under it is in the center of the dose window.
Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in Section 4 of this user manual.
STEP 4 Inject the Dose
Grip pen firmly. Insert needle into skin using the under-the-skin (subcutaneous) injection method explained by your healthcare provider.	PUSH & HOLD Use thumb to firmly push injection button in until it stops. Continue holding in the injection button while slowly counting to 5 to get a full dose. Remove needle from skin.	Injection is complete when the is in the center of the dose window. The pen is now ready to reset.
Note: If you see several drops of BYETTA leaking from the needle after the injection, you may not have received a complete dose. See Commonly Asked Questions, number 4, in Section 4 of this user manual.
STEP 5 Reset the Pen
	Turn dose knob away from you until it stops and the is in the dose window.	Note: If you cannot turn the dose knob, or if your pen leaks, your full dose has not been delivered. See Commonly Asked Questions, numbers 4 and 7, in Section 4 of this user manual.
STEP 6 Remove and Dispose of the Needle
Carefully put the outer needle shield back over the needle. Remove the needle after each injection.	Unscrew the needle.	Throw away needles in a puncture-resistant container or as recommended by your healthcare provider.
STEP 7 Store Pen for Next Dose

• Replace Blue Pen Cap on pen before storage.
• Store your BYETTA Pen at a temperature between 36°F to 77°F (2°C to 25°C). (See Storing Your BYETTA Pen in Section 1 of this user manual for complete storage information.)
• When it is time for your next routine dose, go to Section 3, Step 1, and repeat Steps 1–7.

Section 4

COMMONLY ASKED QUESTIONS

1. Do I need to do the One-Time-Only New Pen Setup before every dose?

• No. The One-Time-Only New Pen Setup is done only once, just before each new pen is used for the first time.
• The purpose of the setup is to make sure that your BYETTA Pen is ready to use for the next 30 days.
• If you repeat the One-Time-Only New Pen Setup before each routine dose, you will not have enough BYETTA for 30 days. The small amount of BYETTA used in the new pen setup will not affect the 30-day supply of BYETTA.

2. Why are there air bubbles in the cartridge?

• A small air bubble is normal. It will not harm you or affect your dose.
• If the pen is stored with a needle attached, air bubbles may form in the cartridge. Do not store the pen with the needle attached.

3. What should I do if BYETTA does not come out of the needle tip after four tries during One-Time-Only New Pen Setup?

• Carefully put the outer needle shield back over the needle. Remove the needle by unscrewing it. Throw away the needle properly.
• Attach a new needle and repeat One-Time-Only New Pen Setup, Steps B–E, in Section 2 of this user manual. Once you see several drops or a stream of liquid coming out of the tip of the needle, the setup is complete.

4. Why do I see BYETTA leaking from my needle after I have finished my injection?

It is normal for a single drop to remain on the tip of your needle after your injection is complete. If you see more than one drop:

• You may not have received your full dose. Do not inject another dose. Talk with your healthcare provider about what to do about a partial dose.
• To make sure that you get your full dose, when you take your injections, firmly push and hold the injection button in and slowly count to 5 (see Section 3, Step 4: Inject the Dose).

5. How can I tell when the injection is complete?

The injection is complete when:

• You have firmly pushed the injection button in all the way until it stops
  and
• You have slowly counted to 5 while you are still holding the injection button in and the needle is still in your skin
  and

• The is in the center of the dose window.

If you hear a click sound from your BYETTA Pen, ignore it. You must follow all the steps listed above to make sure your injection is complete.

6. Where should I inject BYETTA?

Inject BYETTA into your abdomen, thigh, or upper arm using the injection method explained to you by your healthcare provider.

7. What if I cannot pull, turn, or push the dose knob?

 

Check the symbol in the dose window. Follow the steps next to the matching symbol.

 

If is in the dose window:

• Pull the dose knob out until appears.

 

If is in the dose window and the dose knob will not turn:

• The cartridge in your BYETTA Pen may not have enough medicine to deliver a full dose. A small amount of BYETTA will always stay in the cartridge. If the cartridge contains a small amount and the dose knob will not turn, your pen does not have enough BYETTA and will not deliver any more doses. Obtain a new BYETTA Pen.

 

If and part of are in the dose window and the dose knob cannot be pushed in:

• The dose knob was not turned all the way. Continue turning the dose knob away from you until is in the center of the dose window.

 

If part of and part of are in the dose window and the dose knob cannot be pushed in:

• The needle may be clogged, bent, or incorrectly attached.
• Attach a new needle. Make sure needle is on straight and screwed on all the way.
• Firmly push the injection button in all the way. BYETTA should come from needle tip.

 

If is in the dose window and the dose knob will not turn:

• The injection button was not pushed in all the way and a complete dose was not delivered. Talk with your healthcare provider about what to do about a partial dose.
• Follow these steps to reset your pen for your next injection:

  –

  Firmly push the injection button in all the way until it stops. Keep holding the injection button in and slowly count to 5. Then release the injection button and turn the dose knob away from you until appears in the dose window.

  –

  If you cannot turn the dose knob, the needle may be clogged. Replace the needle and repeat the step above.

• For your next dose, be sure to firmly push and hold the injection button in and slowly count to 5 before removing needle from skin.

Manufactured for Amylin Pharmaceuticals, Inc., San Diego, CA 92121. All rights reserved. BYETTA is a registered trademark of Amylin Pharmaceuticals, Inc.
© 2007, 2011 Amylin Pharmaceuticals, Inc.
Literature revised December 2011
825001-08
PV 5017 UCP

10 mcg PEN USER MANUAL

Section 1
 
Read this section completely before you begin. Then, move on to Section 2—Getting Started.

WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN

Byetta® exenatide injection   250 mcg/mL, 2.4 mL   10 mcg

PEN USER MANUAL

PEN USER MANUAL

Read these instructions carefully BEFORE using your BYETTA Pen. For complete dosing and safety information, also read the BYETTA Medication Guide that comes with the BYETTA Pen carton.

It is important that you use your pen correctly. Failure to follow these instructions completely may result in a wrong dose, a broken pen or an infection.

These instructions do not take the place of talking with your healthcare provider about your medical condition or your treatment. If you are having problems using your BYETTA Pen, call toll free 800-868-1190.

IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN

• Each BYETTA Pen contains enough medicine for injection two times each day for 30 days. You do not have to measure any doses, the pen measures each dose for you.
• Do not transfer the medicine in the BYETTA Pen to a syringe or vial.
• Do not mix BYETTA and insulin in the same syringe or vial even if you take them at the same time.
• If any part of your pen appears broken or damaged, do not use the pen.
• This BYETTA Pen is not recommended for use by people who are blind or have vision problems without the help of a person trained in the proper use of the pen.
• Follow the injection method explained to you by your healthcare provider.
• Follow Section 2 only to set up a new pen before first use.
• Section 3 of this manual should be used for every injection.

ABOUT PEN NEEDLES

What kinds of needles can be used with my BYETTA Pen?

• Pen needles are not included with your pen. You may need a prescription to get them from your pharmacist.
• Use 29 (thin), 30, or 31 (thinner) gauge disposable pen needles with your BYETTA Pen. Ask your healthcare provider which needle gauge and length is best for you.

Do I use a new needle for each injection?

• Yes. Do not reuse needles.
• Remove the needle from the pen immediately after you complete each injection. This will help prevent leakage of BYETTA, keep out air bubbles, reduce needle clogs, and decrease the risk of infection.
• Do not push the injection button on your pen unless a needle is attached to the pen.

How do I throw away my needles?

• Do not throw away the pen with a needle attached.
• Place used needles in a closeable, puncture-resistant container. You may use a sharps container (such as a red biohazard container), a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). Ask your healthcare provider for instructions on the right way to throw away (dispose of) your used pens and the container. There may be state and local laws about how you should throw away used pens and needles.
• Do not throw the disposal container in the household trash. Do not recycle.
• Always keep the puncture-proof container out of reach of children.

Never share your BYETTA pen or needles with another person. You may give an infection to them, or get an infection from them, and BYETTA may harm them.

STORING YOUR BYETTA PEN

How do I store my BYETTA Pen?

• Prior to first use, store your unused BYETTA Pen in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C).
• After first use, your BYETTA Pen can be kept at a temperature not to exceed 77°F (25°C).
• Do not freeze. Do not use BYETTA if it has been frozen. BYETTA should be protected from light.
• When carrying the pen away from home, store the pen at a temperature between 36°F to 77°F (2°C to 25°C) and keep dry.
• Do not store the pen with the needle attached. If the needle is left on the pen, BYETTA may leak from the pen and air bubbles may form in the cartridge.

Keep your pen and needles out of the reach of children.

How long can I use a BYETTA Pen?

• You can use your BYETTA Pen for up to 30 days after setting up a new pen for first use. After 30 days, throw away the BYETTA Pen, even if it is not completely empty.
• Mark the date when you first used your pen and the date 30 days later in the spaces below:

Date of First Use                       Date to Throw Away Pen                 

• BYETTA should not be used after the expiration date printed on the pen label.

How do I clean my BYETTA Pen?

• Wipe the outside of the pen with a clean, damp cloth.
• White particles may appear on the outside tip of the cartridge during normal use. You may remove them with an alcohol wipe or alcohol swab.

See the complete BYETTA Medication Guide
that comes with BYETTA. For more information,
call toll free 800-868-1190 or visit www.BYETTA.com

Section 2
 
Read and follow the directions in this section only after you've read Section 1—What You Need To Know About Your BYETTA Pen.

GETTING STARTED

Set up your new pen just before you use it the first time. For routine use, do not repeat this one-time-only new pen setup. If you do, you will run out of BYETTA before 30 days of use.

ONE-TIME-ONLY NEW PEN SETUP
STEP A Check the Pen
		Note: A small air bubble in the cartridge is normal.
Wash hands prior to use. Check pen label to make sure it is your 10 mcg pen. Pull off the blue pen cap.	Check BYETTA in the cartridge. The liquid should be clear, colorless, and free of particles. If not, do not use.
STEP B Attach the Needle
Remove paper tab from outer needle shield. Push outer needle shield containing the needle straight onto the pen, then screw needle on until secure.	Pull off outer needle shield. Do not throw away.	Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal.
STEP C Dial the Dose
Check that the is in the dose window. If not, turn dose knob away from you (clockwise) until it stops and the is in the dose window.	Pull dose knob out until it stops and the is in the dose window.	Turn dose knob away from you until it stops at . Make sure that the 10 with the line under it is in the center of the dose window.
Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in Section 4 of this user manual.
STEP D Prepare the Pen
Point the needle of the pen up and away from you.	PUSH & HOLD Use thumb to firmly push injection button in until it stops, then continue holding the injection button in while slowly counting to 5. If you do not see a stream or several drops come from the needle tip, repeat Steps C & D.	Pen preparation is complete when the is in the center of the dose window AND you have seen a stream or several drops come from the needle tip.
Note: If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of this user manual.
STEP E Complete New Pen Setup
Turn dose knob away from you until it stops and the is in the dose window.	For routine use, do not repeat this one-time-only new pen setup. If you do, you will run out of BYETTA before 30 days of use.	You are now ready for your first dose of BYETTA. Go to Section 3, Step 3, for instructions on how to inject your first routine dose.
Note: If you cannot turn the dose knob, see Commonly Asked Questions, number 7, in Section 4 of user manual.

Section 3
Now that you have done the one-time-only new pen setup, follow Section 3 for all of your injections.
ROUTINE USE
STEP 1 Check the Pen
Wash hands prior to use. Check pen label to make sure it is your 10 mcg pen. Pull off the blue pen cap.	Check BYETTA in the cartridge. The liquid should be clear, colorless, and free of particles. If it is not, do not use.	Note: A small air bubble will not harm you or affect your dose.
STEP 2 Attach the Needle
Remove paper tab from outer needle shield. Push outer needle shield containing the needle straight onto pen, then screw needle on until secure.	Pull off outer needle shield. Do not throw away.	Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal.
STEP 3 Dial the Dose
Check that the is in the dose window. If not, turn dose knob away from you (clockwise) until it stops and the is in the dose window.	Pull dose knob out until it stops and the is in the dose window.	Turn dose knob away from you until it stops at . Make sure that the 10 with the line under it is in the center of the dose window.
Note: If you cannot turn the dose knob away from you to the , see Commonly Asked Questions, number 7, in Section 4 of this user manual.
STEP 4 Inject the Dose
Grip pen firmly. Insert needle into skin using the under-the-skin (subcutaneous) injection method explained by your healthcare provider.	PUSH & HOLD Use thumb to firmly push injection button in until it stops. Continue holding in the injection button while slowly counting to 5 to get a full dose. Remove needle from skin.	Injection is complete when the is in the center of the dose window. The pen is now ready to reset.
Note: If you see several drops of BYETTA leaking from the needle after the injection, you may not have received a complete dose. See Commonly Asked Questions, number 4, in Section 4 of this user manual.
STEP 5 Reset the Pen
	Turn dose knob away from you until it stops and the is in the dose window.	Note: If you cannot turn the dose knob, or if your pen leaks, your full dose has not been delivered. See Commonly Asked Questions, numbers 4 and 7, in Section 4 of this user manual.
STEP 6 Remove and Dispose of the Needle
Carefully put the outer needle shield back over the needle. Remove the needle after each injection.	Unscrew the needle.	Throw away needles in a puncture-resistant container or as recommended by your healthcare provider.
STEP 7 Store Pen for Next Dose

• Replace Blue Pen Cap on pen before storage.
• Store your BYETTA Pen at a temperature between 36°F to 77°F (2°C to 25°C). (See Storing Your BYETTA Pen in Section 1 of this user manual for complete storage information.)
• When it is time for your next routine dose, go to Section 3, Step 1, and repeat Steps 1–7.

Section 4

COMMONLY ASKED QUESTIONS

1. Do I need to do the One-Time-Only New Pen Setup before every dose?

• No. The One-Time-Only New Pen Setup is done only once, just before each new pen is used for the first time.
• The purpose of the setup is to make sure that your BYETTA Pen is ready to use for the next 30 days.
• If you repeat the One-Time-Only New Pen Setup before each routine dose, you will not have enough BYETTA for 30 days. The small amount of BYETTA used in the new pen setup will not affect the 30-day supply of BYETTA.

2. Why are there air bubbles in the cartridge?

• A small air bubble is normal. It will not harm you or affect your dose.
• If the pen is stored with a needle attached, air bubbles may form in the cartridge. Do not store the pen with the needle attached.

3. What should I do if BYETTA does not come out of the needle tip after four tries during One-Time-Only New Pen Setup?

• Carefully put the outer needle shield back over the needle. Remove the needle by unscrewing it. Throw away the needle properly.
• Attach a new needle and repeat One-Time-Only New Pen Setup, Steps B–E, in Section 2 of this user manual. Once you see several drops or a stream of liquid coming out of the tip of the needle, the setup is complete.

4. Why do I see BYETTA leaking from my needle after I have finished my injection?

It is normal for a single drop to remain on the tip of your needle after your injection is complete. If you see more than one drop:

• You may not have received your full dose. Do not inject another dose. Talk with your healthcare provider about what to do about a partial dose.
• To make sure that you get your full dose, when you take your injections, firmly push and hold the injection button in and slowly count to 5 (see Section 3, Step 4: Inject the Dose).

5. How can I tell when the injection is complete?

The injection is complete when:

• You have firmly pushed the injection button in all the way until it stops
  and
• You have slowly counted to 5 while you are still holding the injection button in and the needle is still in your skin
  and

• The is in the center of the dose window.

If you hear a click sound from your BYETTA Pen, ignore it. You must follow all the steps listed above to make sure your injection is complete.

6. Where should I inject BYETTA?

Inject BYETTA into your abdomen, thigh, or upper arm using the injection method explained to you by your healthcare provider.

7. What if I cannot pull, turn, or push the dose knob?

 

Check the symbol in the dose window. Follow the steps next to the matching symbol.

 

If is in the dose window:

• Pull the dose knob out until appears.

 

If is in the dose window and the dose knob will not turn:

• The cartridge in your BYETTA Pen may not have enough medicine to deliver a full dose. A small amount of BYETTA will always stay in the cartridge. If the cartridge contains a small amount and the dose knob will not turn, your pen does not have enough BYETTA and will not deliver any more doses. Obtain a new BYETTA Pen.

 

If and part of are in the dose window and the dose knob cannot be pushed in:

• The dose knob was not turned all the way. Continue turning the dose knob away from you until is in the center of the dose window.

 

If part of and part of are in the dose window and the dose knob cannot be pushed in:

• The needle may be clogged, bent, or incorrectly attached.
• Attach a new needle. Make sure needle is on straight and screwed on all the way.
• Firmly push the injection button in all the way. BYETTA should come from needle tip.

 

If is in the dose window and the dose knob will not turn:

• The injection button was not pushed in all the way and a complete dose was not delivered. Talk with your healthcare provider about what to do about a partial dose.
• Follow these steps to reset your pen for your next injection:

  –

  Firmly push the injection button in all the way until it stops. Keep holding the injection button in and slowly count to 5. Then release the injection button and turn the dose knob away from you until appears in the dose window.

  –

  If you cannot turn the dose knob, the needle may be clogged. Replace the needle and repeat the step above.

• For your next dose, be sure to firmly push and hold the injection button in and slowly count to 5 before removing needle from skin.

Manufactured for Amylin Pharmaceuticals, Inc., San Diego, CA 92121. All rights reserved. BYETTA is a registered trademark of Amylin Pharmaceuticals, Inc.
© 2007, 2011 Amylin Pharmaceuticals, Inc.
Literature revised December 2011
925001-08
PV 5027 UCP

PRINCIPAL DISPLAY PANEL - 5 mcg

5
mcg

NDC 54868-5384-0

Byetta®
exenatide injection
250 mcg/mL, 1.2 mL

Dispense the enclosed Medication Guide to each patient

Each prefilled pen will deliver 60 subcutaneous doses, 5 mcg per dose
Rx Only

SUBCUTANEOUS USE ONLY     REFRIGERATE – DO NOT FREEZE
DO NOT TRANSFER THIS MEDICATION TO A SYRINGE

Pen needles not included

Ask your healthcare provider which pen needle length and gauge is best for you
Use 29 (thin), 30, or 31 (thinner) gauge disposable pen needles