Byetta (Exenatide): Uses, Side Effects and Dosage

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

• Serious side effects can happen in people who take BYETTA, including inflammation of your pancreas (pancreatitis). Stop using BYETTA 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.

What is BYETTA?

• BYETTA is an injectable prescription medicine that is used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus.
• BYETTA is not recommended for people who take exenatide or other medicines called glucagon-like peptide 1 (GLP-1) receptor agonist.
• It is not known if BYETTA is safe and effective in children.

Who should not use BYETTA?

Do not use BYETTA if:

• you have had a severe 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. See “What are the possible side effects of BYETTA?” for symptoms of a serious allergic reaction.
• you have a history of low blood platelet count from using exenatide medicines (drug-induced thrombocytopenia).

Before taking BYETTA, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had problems with your pancreas.
• have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).

• are pregnant or plan to become pregnant. It is not known if BYETTA will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking BYETTA. 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 BYETTA passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while taking BYETTA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BYETTA may affect the way some medicines work and some other medicines may affect the way BYETTA works.

Before using BYETTA, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.

Especially tell your healthcare provider if you take:

• 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 at a time when you do not also take BYETTA.

• antibiotics. 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 at a time when you do not also take BYETTA.
• warfarin
• lovastatin

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 BYETTA?

• Read the Instructions for Use that comes with BYETTA.
• Use BYETTA exactly as your healthcare provider tells you to.
• Your healthcare provider should teach you how to inject BYETTA before you use it for the first time.
• 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 muscle (intramuscularly) or vein (intravenously).
• Inject BYETTA two times each day, at any time within 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.
• Do not mix insulin and BYETTA together in the same injection.
• You may give an injection of BYETTA and insulin in the same body area (such as your stomach area), but not right next to each other.
• Change (rotate) your injection sites within the area you chose with each dose. Do not use the same spot for each injection.
• Do not share your BYETTA pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
• If you take too much BYETTA, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the possible side effects of BYETTA?

BYETTA may cause serious side effects, including:

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

• 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
• dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
• severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use BYETTA. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
• low blood platelet count (drug-induced thrombocytopenia). BYETTA 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 BYETTA and call your healthcare provider right away if you have unusual bleeding or bruising.

• severe allergic reactions. Stop taking BYETTA and get medical help right away if you have any symptom of a severe allergic reaction including:

  • swelling of your face, lips, tongue or throat
  • problems breathing or swallowing
  • severe rash or itching
  • fainting or feeling dizzy
  • very rapid heartbeat

• gallbladder problems. Gallbladder problems have happened in some people who take BYETTA. 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
• food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). BYETTA may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking BYETTA before you are scheduled to have surgery or other procedures.

The most common side effects of BYETTA include:

• nausea
• feeling jittery
• indigestion
• vomiting
• dizziness
• constipation
• diarrhea
• headache
• weakness

Talk to your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of 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 8°C).
• 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.
• Keep your BYETTA Pen, pen needles, and all medicines out of the reach of children.

General information about the safe and effective use of 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 that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about BYETTA that is written for health professionals.

What are the ingredients in BYETTA?

Active ingredient: exenatide

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

BYETTA^® is a registered trademark of the AstraZeneca group of companies. All other trademarks are the trademarks of their respective owners.

Distributed by:

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

For more information, call 1-800-236-9933.

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised 05/2025

INSTRUCTIONS FOR USE

BYETTA^® (bye-A-tuh)

(exenatide) injection

for subcutaneous use

5 mcg /dose, 300 mcg/1.2 mL (250 mcg/mL)

Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

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

INSTRUCTIONS FOR USE

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 1-800-236-9933.

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 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 these Instructions for Use 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 or share your needles with other people. You may give other people a serious infection or get a serious infection from them.
• 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?

Put your used needles in a FDA-cleared 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, 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 syringes.

Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from 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 cooler than 77°F (25°C).
• Do not freeze your BYETTA Pen. 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 in a FDA-cleared sharps disposal container, 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 1-800-236-9933.

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: Small air bubbles in the cartridge are 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 these Instructions for Use.

STEP D Prepare the Pen

PUSH & HOLD

• Point the needle of the pen up and away from you.

• 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: Each device contains additional volume to allow for troubleshooting the device 4 times.If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of these Instructions for Use.

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 Instructions for Use.

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

Note: Small air bubbles will not harm you or affect your dose.

• 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.

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 these Instructions for Use.

STEP 4 Inject the Dose

PUSH & HOLD

• Grip pen firmly.
• Insert needle into skin using the under-the-skin (subcutaneous) injection method explained by your healthcare provider.

• 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 these Instructions for Use.

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 these Instructions for Use.

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 FDA-cleared sharps disposal container (See above “How do I throw away my needles?”) 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 these Instructions for Use 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 these Instructions for Use. 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.

Change (rotate) your injection sites within the area you choose for each dose. Do not use the same injection site for each injection.

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. Get 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.

See the complete BYETTA Medication Guide that comes with BYETTA. For more information, call toll free 1-800-236-9933.

Distributed by:

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

BYETTA^® is a registered trademark of the AstraZeneca group of companies.

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

Revised: September 2025

Medication Guide

INSTRUCTIONS FOR USE

BYETTA^® (bye-A-tuh)

(exenatide) injection

for subcutaneous use

10 mcg/dose, 600 mcg/ 2.4 ml (250 mcg/mL)

Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

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 INSTRUCTIONS FOR USE

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 1-800-236-9933.

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 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 these Instructions for Use 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 or share your needles with other people. You may give other people a serious infection or get a serious infection from them.
• 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?

Put your used needles in a FDA-cleared 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, 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 syringes.

Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from 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 cooler than 77°F (25°C).
• Do not freeze your BYETTA Pen. 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 in a FDA-cleared sharps disposal container, 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 1-800-236-9933.

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: Small air bubbles in the cartridge are 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 these Instructions for Use.

STEP D Prepare the Pen

PUSH & HOLD

• Point the needle of the pen up and away from you.

• 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: Each device contains additional volume to allow for troubleshooting the device 4 times. If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of these Instructions for Use.

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 these Instructions for Use.

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

Note: Small air bubbles will not harm you or affect your dose.

• 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.

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 these Instructions for Use.

STEP 4 Inject the Dose

PUSH & HOLD

• Grip pen firmly.
• Insert needle into skin using the under-the-skin (subcutaneous) injection method explained by your healthcare provider.

• 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 these Instructions for Use.

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 these Instructions for Use.

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 FDA-cleared sharps disposal container (See above “How do I throw needles?”) 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 these Instructions for Use 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 these Instructions for Use. 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.

Change (rotate) your injection sites within the area you choose for each dose. Do not use the same injection site for each injection.

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.

See the complete BYETTA Medication Guide that comes with BYETTA. For more information, call toll free 1-800-236-9933.

Distributed by:

AstraZeneca Pharmaceuticals LP

Wilmington, DE 19850

BYETTA^® is a registered trademark of the AstraZeneca group of companies.

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

Revised: September 2025