Patient information: uses, side effects, how to take - Exenatide
What is the most important information I should know about exenatide injection?
- Serious side effects can happen in people who take exenatide injection, including inflammation of your pancreas (pancreatitis). Stop using exenatide injection 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 nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.
What is exenatide injection?
- Exenatide 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.
- Exenatide 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 exenatide injection is safe and effective in children.
Who should not use exenatide injection?
Do not use exenatide injection if:
- you have had a severe allergic reaction to exenatide or any of the other ingredients in exenatide injection. See the end of this Medication Guide for a complete list of ingredients in exenatide injection. See “What are the possible side effects of exenatide injection?” 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 exenatide injection, 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 exenatide injection will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking exenatide injection. 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 exenatide passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while taking exenatide injection.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Exenatide injection may affect the way some medicines work and some other medicines may affect the way exenatide injection works.
Before using exenatide injection, 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). Exenatide injection 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 exenatide. 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 exenatide injection.
- antibiotics. Take antibiotic medicines at least one hour before taking exenatide injection. If you must take your antibiotic with food, take it with a meal or snack at a time when you do not also take exenatide injection.
- 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 exenatide injection?
- Read the Instructions for Use that comes with exenatide injection.
- Use exenatide injection exactly as your healthcare provider tells you to.
- Your healthcare provider should teach you how to inject exenatide before you use it for the first time.
- Inject your dose of exenatide 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 exenatide injection 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 exenatide injection after your meal.
- If you miss a dose of exenatide injection, 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 exenatide together in the same injection.
- You may give an injection of exenatide 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 exenatide 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 exenatide, 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 exenatide injection?
Exenatide injection may cause serious side effects, including:
- See “What is the most important information I should know about exenatide injection?”
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take exenatide injection 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
- blurred vision
- anxiety, irritability or mood change
- sweating
- slurred speech
- hunger
- confusion or drowsiness
- shakiness
- weakness
- headache
- fast heartbeat
- 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 exenatide injection. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
- low blood platelet count (drug-induced thrombocytopenia). Exenatide injection 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 exenatide injection and call your healthcare provider right away if you have unusual bleeding or bruising.
- severe allergic reactions. Stop taking exenatide injection 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
- fainting or feeling dizzy
- problems breathing or swallowing
- very rapid heartbeat
- severe rash or itching
- gallbladder problems. Gallbladder problems have happened in some people who take exenatide injection. 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). Exenatide injection may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking exenatide injection before you are scheduled to have surgery or other procedures.
The most common side effects of exenatide injection 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 exenatide injection.
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 exenatide injection?
- Store your new, unused exenatide injection pen in the original carton in a refrigerator at 36° to 46°F (2° to 8°C).
- After first use, keep your exenatide injection pen at a temperature cooler than 77°F (25°C).
- Do not freeze your exenatide injection pen. Do not use exenatide injection if it has been frozen.
- Protect exenatide injection from light.
- Use an exenatide injection pen for only 30 days. Throw away a used exenatide injection pen after 30 days, even if there is some medicine left in the pen.
- Do not use exenatide injection after the expiration date printed on the label.
- Keep your exenatide injection pen, pen needles and all medicines out of the reach of children.
General information about the safe and effective use of exenatide injection.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use exenatide injection for a condition for which it was not prescribed. Do not give exenatide injection 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 exenatide injection that is written for health professionals.
What are the ingredients in exenatide injection?
Active ingredient: exenatide, USP
Inactive ingredients: metacresol, mannitol, glacial acetic acid and sodium acetate trihydrate in water for injection.
For more information, go to www.amneal.com or call 1-877-835-5472.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All trademarks are property of their respective owners.
Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad 382213, INDIA
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 05-2026-07
INSTRUCTIONS FOR USE
Exenatide (ex en’ a tide) Injection, USP
for subcutaneous use
5 mcg/dose 300 mcg/1.2 mL ( 250 mcg/mL)
Do not share your Exenatide Injection 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 EXENATIDE INJECTION PEN
INSTRUCTIONS FOR USE
Read these instructions carefully BEFORE using your Exenatide Injection Pen. For complete dosing and safety information, also read the Exenatide Injection Medication Guide that comes with the Exenatide Injection 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 Exenatide Injection Pen, call toll free 1-877-835-5472.
IMPORTANT INFORMATION ABOUT YOUR EXENATIDE INJECTION PEN
- Each Exenatide Injection 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 Exenatide Injection 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 Exenatide Injection 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 Exenatide Injection 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 Exenatide Injection 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 Exenatide Injection, 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 Exenatide Injection 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 EXENATIDE INJECTION PEN
How do I store my Exenatide Injection Pen?
- Prior to first use, store your unused Exenatide Injection Pen in the original carton in a refrigerator at 36° to 46°F (2° to 8°C).
- After first use, your Exenatide Injection Pen can be kept at a temperature cooler than 77°F (25°C).
- Do not freeze your Exenatide Injection Pen. Do not use Exenatide Injection if it has been frozen. Exenatide Injection should be protected from light.
- When carrying the pen away from home, store the pen at a temperature between 36° to 77°F (2° to 25°C) and keep dry.
- Do not store the pen with the needle attached. If the needle is left on the pen, Exenatide Injection 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 an Exenatide Injection Pen?
- You can use your Exenatide Injection Pen for up to 30 days after setting up a new pen for first use. After 30 days, throw away the Exenatide Injection 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 _________________
- Exenatide Injection should not be used after the expiration date printed on the pen label.
How do I clean my Exenatide Injection 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 Exenatide Injection Medication Guide that comes with Exenatide Injection. For more information, call toll free 1-877-835-5472.
Section 2 Read and follow the directions in this section only after you’ve read Section 1—What You Need To Know About Your Exenatide Injection 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 Exenatide Injection before 30 days of use.
ONE-TIME-ONLY NEW PEN SETUP
STEP 1 Check the Pen
 a. Wash hands prior to use. b. Check pen label to make sure it is your 5 mcg pen. c. Pull off the blue pen cap. |  d. Check Exenatide Injection in the cartridge. The liquid should be clear, colorless, and free of particles. If not, do not use. | Note: Small air bubbles in the cartridge are normal. |
STEP 2 Attach the Needle
 a. Remove paper tab from outer needle shield. b. Push outer needle shield containing the needle straight onto pen, then screw needle on until secure. |  c. Pull off outer needle shield. Do not throw away. |  d. Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal. |
STEP 3 Dial the Dose
 a. Check that the |  b. Turn the dose knob away from you (clockwise) until it stops completely and the dose knob cannot be rotated any further (clockwise). When the dose knob has been turned completely, the 5 with the line under it will be at the center of the dose window and the • will be in the nose of the dose window | CAUTION: Make sure that the • is in the nose and the 5 with the line under it is in the center of the dose window before proceeding to the next step.  |
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 Prepare the Pen
 a. Point the needle of the pen up and away from you. |  PUSH & HOLD b. Use thumb to firmly push injection button in until it stops, then continue holding the injection button in while slowly counting to 5. c. If you do not see a stream or several drops come from the needle tip, repeat Steps 3 & 4. |  d. Pen preparation is complete when the |
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 5 Complete New Pen Setup
| a. For routine use, do not repeat this one-time-only new pen setup. If you do, you will run out of Exenatide Injection before 30 days of use. | b. You are now ready for your first dose of Exenatide Injection. c. Go to Section 3, Step 3, for instructions on how to inject your first routine dose. |
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
a. Wash hands prior to use. b. Check pen label to make sure it is your 5 mcg pen. c. Pull off the blue pen cap. | d. Check Exenatide Injection in the cartridge. e. The liquid should be clear, colorless, and free of particles. If it is not, do not use. | Note: Small air bubbles will not harm you or affect your dose. |
STEP 2 Attach the Needle
 a. Remove paper tab from outer needle shield. b. Push outer needle shield containing the needle straight onto pen, then screw needle on until secure. |  c. Pull off outer needle shield. Do not throw away. |  d. Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal. |
STEP 3 Dial the Dose
a. Check that the | b. Turn the dose knob away from you (clockwise) until it stops completely and the dose knob cannot be rotated any further (clockwise). When the dose knob has been turned completely, the 5 with the line under it will be at the center of the dose window and the • will be in the nose of the dose window | CAUTION: Make sure that the • is in the nose and the 5 with the line under it is in the center of the dose window before proceeding to the next step. |
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
 a. Grip pen firmly. b. Insert needle into skin using the under-the-skin (subcutaneous) injection method explained by your healthcare provider. |  PUSH & HOLD c. 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. d. Remove needle from skin. |  e. Injection is complete when the f. The pen is also now reset for the next injection dose. |
Note: If you see several drops of Exenatide Injection 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 Remove and Dispose of the Needle
 a. Carefully put the outer needle shield back over the needle. b. Remove the needle after each injection. |  c. Unscrew the needle. |  d. 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 6 Store Pen for Next Dose
a. Replace Blue Pen Cap on pen before storage.
b. Store your Exenatide Injection Pen at a temperature between 36° to 77°F (2° to 25°C). (See Storing Your Exenatide Injection Pen in Section 1 of these Instructions for Use for complete storage information.)
c. When it is time for your next routine dose, go to Section 3, Step 1, and repeat Steps 1 to 6.
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 Exenatide Injection 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 Exenatide Injection for 30 days. The small amount of Exenatide Injection used in the new pen setup will not affect the 30-day supply of Exenatide Injection.
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 Exenatide Injection 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 2 to 5, 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 Exenatide Injection 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 Exenatide Injection Pen, ignore it. You must follow all the steps listed above to make sure your injection is complete.
6. Where should I inject Exenatide Injection?
Inject Exenatide Injection 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 turn the dose knob or the injection button cannot be pushed in?
Check the symbol in the dose window. Follow the steps next to the matching symbol.
If is in the dose window and the dose knob will not turn:
- The cartridge in your Exenatide Injection Pen may not have enough medicine to deliver a full dose. A small amount of Exenatide Injection 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 Exenatide Injection and will not deliver any more doses. Get a new Exenatide Injection Pen. (or)
The injection button was not pushed in all the way during the previous dose 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 until appears in the dose window and slowly count to 5. Then release the injection button.
- 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.
If is in the dose window and the injection button 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. Exenatide Injection should come from needle tip.
See the complete Exenatide Injection Medication Guide that comes with Exenatide Injection. For more information, call toll free 1-877-835-5472.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad 382213, INDIA
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 12-2025-08
-------------------------------------------------------------------------------------------
INSTRUCTIONS FOR USE
Exenatide (ex en’ a tide) Injection, USP
for subcutaneous use
10 mcg/dose 600 mcg/2.4 mL (250 mcg/mL)
Do not share your Exenatide Injection 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 EXENATIDE INJECTION PEN
INSTRUCTIONS FOR USE
Read these instructions carefully BEFORE using your Exenatide Injection Pen. For complete dosing and safety information, also read the Exenatide Injection Medication Guide that comes with the Exenatide Injection 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 Exenatide Injection Pen, call toll free 1-877-835-5472.
IMPORTANT INFORMATION ABOUT YOUR EXENATIDE INJECTION PEN
- Each Exenatide Injection 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 Exenatide Injection 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 Exenatide Injection 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 Exenatide Injection 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 Exenatide Injection 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 Exenatide Injection, 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 Exenatide Injection 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 EXENATIDE INJECTION PEN
How do I store my Exenatide Injection Pen?
- Prior to first use, store your unused Exenatide Injection Pen in the original carton in a refrigerator at 36° to 46°F (2° to 8°C).
- After first use, your Exenatide Injection Pen can be kept at a temperature cooler than 77°F (25°C).
- Do not freeze your Exenatide Injection Pen. Do not use Exenatide Injection if it has been frozen. Exenatide Injection should be protected from light.
- When carrying the pen away from home, store the pen at a temperature between 36° to 77°F (2° to 25°C) and keep dry.
- Do not store the pen with the needle attached. If the needle is left on the pen, Exenatide Injection 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 an Exenatide Injection Pen?
- You can use your Exenatide Injection Pen for up to 30 days after setting up a new pen for first use. After 30 days, throw away the Exenatide Injection 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 _________________
- Exenatide Injection should not be used after the expiration date printed on the pen label.
How do I clean my Exenatide Injection 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 Exenatide Injection Medication Guide that comes with Exenatide Injection. For more information, call toll free 1-877-835-5472.
Section 2 Read and follow the directions in this section only after you’ve read Section 1—What You Need To Know About Your Exenatide Injection 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 Exenatide Injection before 30 days of use.
ONE-TIME-ONLY NEW PEN SETUP
STEP 1 Check the Pen
 a. Wash hands prior to use. b. Check pen label to make sure it is your 10 mcg pen. c. Pull off the blue pen cap. |  d. Check Exenatide Injection in the cartridge. The liquid should be clear, colorless, and free of particles. If not, do not use. | Note: Small air bubbles in the cartridge are normal. |
STEP 2 Attach the Needle
 a. Remove paper tab from outer needle shield. b. Push outer needle shield containing the needle straight onto the pen, then screw needle on until secure. |  c. Pull off outer needle shield. Do not throw away. |  d. Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal. |
STEP 3 Dial the Dose
 a. Check that the |  b. Turn the dose knob away from you (clockwise) until it stops completely and the dose knob cannot be rotated any further (clockwise). When the dose knob has been turned completely, the 10 with the line under it will be at the center of the dose window and the • will be in the nose of the dose window | CAUTION: Make sure that the • is in the nose and the 10 with the line under it is in the center of the dose window before proceeding to the next step.  |
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 Prepare the Pen
 a. Point the needle of the pen up and away from you. |  PUSH & HOLD b. Use thumb to firmly push injection button in until it stops, then continue holding the injection button in while slowly counting to 5. c. If you do not see a stream or several drops come from the needle tip, repeat Steps 3 & 4. |  d. Pen preparation is complete when the |
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 5 Complete New Pen Setup
| a. For routine use, do not repeat this one-time-only new pen setup. If you do, you will run out of Exenatide Injection before 30 days of use. | b. You are now ready for your first dose of Exenatide Injection. c. Go to Section 3, Step 3, for instructions on how to inject your first routine dose. |
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
 a. Wash hands prior to use. b. Check pen label to make sure it is your 10 mcg pen. c. Pull off the blue pen cap. | d. Check Exenatide Injection in the cartridge. e. The liquid should be clear, colorless, and free of particles. If it is not, do not use. | Note: Small air bubbles will not harm you or affect your dose. |
STEP 2 Attach the Needle
 a. Remove paper tab from outer needle shield. b. Push outer needle shield containing the needle straight onto pen, then screw needle on until secure. |  c. Pull off outer needle shield. Do not throw away. |  d. Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal. |
STEP 3 Dial the Dose
 a. Check that the |  b. Turn the dose knob away from you (clockwise) until it stops completely and the dose knob cannot be rotated any further (clockwise). When the dose knob has been turned completely, the 10 with the line under it will be at the center of the dose window and the • will be in the nose of the dose window | CAUTION: Make sure that the • is in the nose and the 10 with the line under it is in the center of the dose window before proceeding to the next step. |
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
 a. Grip pen firmly. b. Insert needle into skin using the under-the-skin (subcutaneous) injection method explained by your healthcare provider. |  PUSH & HOLD c. 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. d. Remove needle from skin. |  e. Injection is complete when the f. The pen is also now reset for the next injection dose. |
Note: If you see several drops of Exenatide Injection 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 Remove and Dispose of the Needle
 a. Carefully put the outer needle shield back over the needle. b. Remove the needle after each injection. |  c. Unscrew the needle. |  d. 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 6 Store Pen for Next Dose
a. Replace Blue Pen Cap on pen before storage.
b. Store your Exenatide Injection Pen at a temperature between 36° to 77°F (2° to 25°C). (See Storing Your Exenatide Injection Pen in Section 1 of these Instructions for Use for complete storage information.)
c. When it is time for your next routine dose, go to Section 3, Step 1, and repeat Steps 1 to 6.
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 Exenatide Injection 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 Exenatide Injection for 30 days. The small amount of Exenatide Injection used in the new pen setup will not affect the 30-day supply of Exenatide Injection.
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 Exenatide Injection 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 2 to 5, 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 Exenatide Injection 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 Exenatide Injection Pen, ignore it. You must follow all the steps listed above to make sure your injection is complete.
6. Where should I inject Exenatide Injection?
Inject Exenatide Injection 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 turn the dose knob or the injection button cannot be pushed in?
Check the symbol in the dose window. Follow the steps next to the matching symbol.
If is in the dose window and the dose knob will not turn:
- The cartridge in your Exenatide Injection Pen may not have enough medicine to deliver a full dose. A small amount of Exenatide Injection 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 Exenatide Injection and will not deliver any more doses. Get a new Exenatide Injection Pen. (or)
The injection button was not pushed in all the way during the previous dose 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 until appears in the dose window and slowly count to 5. Then release the injection button.
- 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.
If is in the dose window and the injection button 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. Exenatide Injection should come from needle tip.
See the complete Exenatide Injection Medication Guide that comes with Exenatide Injection. For more information, call toll free 1-877-835-5472.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad 382213, INDIA
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 12-2025-08