Patient information: uses, side effects, how to take - Awiqli
What is Awiqli?
- Awiqli is a long-acting man-made insulin (U-700) that is used to control high blood sugar in adults with type 2 diabetes mellitus.
- It is not known if Awiqli is safe and effective in children and adolescents.
- Awiqli FlexTouch is only available in one concentration (U-700):
- The Awiqli FlexTouch pen can be injected from 10 units to 700 units in a single injection, in 10 unit increments.
Who should not take Awiqli?
Do not take Awiqli if you:
- are having an episode of low blood sugar (hypoglycemia).
- have an allergy to Awiqli or any of the ingredients in Awiqli. See the end of this Patient Information leaflet for a complete list of ingredients in Awiqli.
Before taking Awiqli, tell your healthcare provider about all your medical conditions including, if you are:
- have liver or kidney problems.
- take other medicines, especially ones called TZDs (thiazolidinediones).
- have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Awiqli.
- pregnant, planning to become pregnant, or are breastfeeding.
- taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.
Before you start taking Awiqli, talk to your healthcare provider about low blood sugar and how to manage it.
How should I take Awiqli FlexTouch?
- Read the Instructions for Use that come with your Awiqli FlexTouch Pen.
- Your healthcare provider should show you how to use Awiqli FlexTouch Pen before you use it for the first time.
- Take Awiqli exactly as your healthcare provider tells you to. Do not do any conversion of your dose. The dose counter always shows the selected dose in units. Awiqli FlexTouch pens are made to deliver your insulin dose in units.
- Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
- Inject Awiqli FlexTouch 1 time each week on any day of the week on the same day each week.
- If you need to change the day of the week, you may do so if your last dose has been at least 4 days.
- If you missed your dose, take your missed dose as soon as possible as long as it has been 4 days or less. Then continue the 1 time each week schedule 1 week from the day your missed dose was taken.
- If more than 4 days has passed, skip the missed dose and take your next Awiqli dose on your regularly scheduled day.
- Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
- Never inject Awiqli FlexTouch into a vein or muscle or use Awiqli in an infusion pump.
- Never use a syringe to remove Awiqli from the FlexTouch pen.
- Do not dilute or mix Awiqli with any other insulin or solution.
- Awiqli FlexTouch can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
- Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
Keep Awiqli and all medicines out of the reach of children.
What should I avoid while taking Awiqli?
While taking Awiqli do not:
- Drive or operate heavy machinery, until you know how Awiqli affects you.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
What are the possible side effects of Awiqli?
Awiqli may cause serious side effects that can lead to death, including:
- Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
- dizziness or light-headedness
- blurred vision
- anxiety, irritability, or mood changes
- sweating
- slurred speech
- hunger
- confusion
- shakiness
- headache
- fast heartbeat
- Severe allergic reaction (whole body reaction). Stop using Awiqli and get medical help right away, if you have any of these signs or symptoms of a severe allergic reaction:
- a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
- Low potassium in your blood (hypokalemia).
- Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Awiqli may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with Awiqli. Your healthcare provider should monitor you closely while you are taking TZDs with Awiqli. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain. Treatment with TZDs and Awiqli may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
Your insulin dose may need to change because of:
- change in level of physical activity or exercise
- increased stress
- change in diet
- weight gain or loss
- illness
Common side effects of Awiqli may include:
- hypoglycemia, serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.
These are not all the possible side effects of Awiqli. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Awiqli.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Awiqli that is written for health professionals. Do not use Awiqli FlexTouch for a condition for which it was not prescribed. Do not give Awiqli to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in Awiqli?
Active Ingredient: insulin icodec-abae
Inactive Ingredients: Glycerin; metacresol; phenol; sodium chloride; zinc acetate and water for injection. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License No. 1261
At: Novo Nordisk A/S
Novo Allé
2880 Bagsvaerd
Denmark
For more information, go to www.awiqli.com or call 1-844-668-6463.
Patent Information: http://novonordisk-us.com/products/product-patents.html
© 2026 Novo Nordisk
- This Patient Information has been approved by the U.S. Food and Drug Administration.Issued: 03/2026
Instructions for Use
INSTRUCTIONS FOR USE Awiqli® [Ah–wik-lee] FlexTouch® (insulin icodec-abae) injection, for subcutaneous use 700 units/mL (U-700) | |
Read these instructions carefully, and talk to your healthcare provider about how to use the needle and inject Awiqli before you begin using your Awiqli FlexTouch Pen. Make sure that you know how to give yourself an injection with the pen before you start your treatment. Important information before you start using your pen:
| |
Information about your pen Awiqli FlexTouch Pen (pen) is a prefilled disposable single-patient-use pen containing 700 units of insulin icodec-abae. You can inject from 10 to 700 units in a single injection. The units can be increased by 10 units at a time. Supplies you will need to give your Awiqli injection:
| |
| Look at the pictures to get to know the different parts of your pen and needle. | |
| Awiqli FlexTouch Pen | |
Note: Your pen may differ in size from the pen shown in the pictures. These instructions apply to all Awiqli FlexTouch Pens.   | |
| Needle | |
About your needles: Your pen is designed to be used with NovoFine® Plus, or NovoFine® disposable needles up to a length of 8 mm. Disposable needles are included in the pack. Always check the flow as described in Step 2 and use a new needle for each injection. Always throw away the needle after each use in a sharps disposal container.  | |
| Step 1: Prepare your pen with a new needle | |
Wash your hands with soap and water. Check the name and concentration on the pen label to make sure that your pen contains Awiqli 700 units/mL. Pull off the pen cap. See Figure A. |  |
Always check that Awiqli in your pen is clear and colorless. Look through the pen window. If Awiqli looks cloudy or contains particles, do not use the pen. See Figure B. |  |
Always use a new needle for each injection. Check the paper tab and the outer needle cap for damage. If you see any damage, this could mean the needle is not clean. Throw away the needle in a sharps disposal container and use a new one. Take a needle and tear off the paper tab. Do not attach a new needle to your pen until you are ready to give your injection. See Figure C. |  |
| Push the needle straight onto the pen. Turn forward until it is on tight. See Figure D. |  |
The needle is covered by 2 caps. You must remove both caps. If you forget to remove both caps, you will not inject any Awiqli. Pull off the outer needle cap and keep it for later. See Figure E. |  |
Pull off the inner needle cap and throw it away. See Figure F. A drop of Awiqli may appear at the needle tip. This is normal, but you must still check the Awiqli flow before each injection. See Step 2. Never use a bent or damaged needle. |  |
| Step 2: Check the flow before each injection | |
Always check the flow before each injection. This helps you to make sure you will get your full Awiqli dose. Turn the dose selector forward until you see the 10 units mark (this is the first mark) on the dose counter. See Figure G. |  |
| Make sure that the mark lines up with the dose pointer. See Figure H. |  |
Hold the pen with the needle pointing up. See Figure I. Press and hold in the dose button until the dose counter shows -0-. The -0- must line up with the dose pointer. A drop of Awiqli should appear at the needle tip. This drop indicates that your pen is ready for use. See Figure I. If a drop does not appear, repeat Step 2 to check the flow again. This should only be done 3 times in total. If there is still no drop, you might have a blocked needle. Change the needle as described in Step 6 and Step 1. Then check the flow again. Do not use the pen if a drop of Awiqli still does not appear. Contact Novo Nordisk at 1-844-668-6463. |  |
| Step 3: Set your dose | |
Check that the dose pointer is set at -0-. Turn the dose selector to select the number of units you need to inject. See Figure J. The units shown in the dose counter will help you select your dose. The dose can be increased by 10 units at a time. You will hear a ‘click’ every time you turn the dose selector. Do not set the dose by counting the number of clicks you hear. If you select a wrong dose, you can turn the dose selector forwards or backwards to the correct dose. |  |
When your dose lines up with the dose pointer, you have selected your dose. Make sure you select the dose prescribed by your healthcare provider. Figure K shows examples of how to choose your dose correctly. If the dose counter stops before you reach your prescribed dose, see “Do you have enough Awiqli?” section below in this Instructions for Use. |  |
| Step 4: Choose your injection site | |
Choose an injection site on your stomach (keep a 2-inch distance from your belly button), upper legs, or upper arms. You may inject in the same body area each week, but make sure it is not in the same spot that was used for your last injection. Clean the injection site with an alcohol swab. Do not touch the injection site after cleaning. |  |
| Step 5: Inject your dose | |
Fully insert the needle straight into your skin. Make sure you can see the dose counter. Do not cover the dose counter or touch it with your fingers. This could stop the injection. Press and hold down the dose button. See Figure L. |  |
|  |
Remove the needle from your skin by pulling straight up. See Figure N. You can then release the dose button. If you remove the needle before you counted to 6 and after the dose counter showed -0-, you may not have received your full dose. If blood appears at the injection site, press lightly with a cotton ball or gauze pad. You may see a drop of Awiqli at the needle tip after injecting. This is normal and does not affect your dose. |  |
| Step 6: After your injection | |
Carefully remove the needle from the pen and throw it away (dispose of it) after each injection.
Never store your pen with the needle attached.
Remove the needle before storing your pen to reduce the chances of contamination, infection, and blocked needle leading to incorrect dose. See Figure O.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Place the needle in a sharps disposal container right away to reduce the risk of needle sticks. See Figure P.
See “Disposing of used Awiqli FlexTouch Pens and needles” below for more information about how to dispose of used pens and needles the right way.
Put the pen cap on your pen after each use to protect Awiqli from light. See Figure Q.
If you do not have a sharps container, carefully slip the needle into the outer needle cap. See Figure R. After the needle is covered, carefully push the outer needle cap completely on and unscrew the needle.
For disposal, see “Disposing of used Awiqli FlexTouch pens and needles”.
Do you have enough Awiqli?
- Turn the dose selector forward until it stops. The dose pointer will line up with the number of units of insulin that is left in your pen.
- If the dose counter shows less than 700, the number shown in the dose counter is the number of units left in your pen.
- If the dose counter shows 700, there are at least 700 units left in your pen.
- If the dose counter stops before you reach your dose, there is not enough Awiqli left for a full dose. Use a new pen to inject your full dose.
Disposing of used Awiqli FlexTouch pens and needles
- Put your used needles and Awiqli FlexTouch pens that are no longer usable in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the loose needles 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,
- able to 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 local or state laws about how you should throw away used needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
- Do not recycle your used sharps disposal container.
- Safely dispose of Awiqli FlexTouch pens that are expired or no longer needed in a sharps disposal container.
- The pen cap and the empty carton can be disposed of in your household trash.
How should I store my Awiqli FlexTouch pens?
- Store your unused Awiqli FlexTouch pens in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date printed on the carton.
- Store the pen you are currently using for up to 12 weeks at room temperature below 86°F (30°C) or in a refrigerator between 36°F to 46°F (2°C to 8°C).
- Unused Awiqli FlexTouch pen stored at room temperature below 86°F (30°C) should be thrown away after 12 weeks.
- When stored in the refrigerator, do not store Awiqli FlexTouch pens directly next to the cooling element.
- Do not freeze Awiqli. Do not use Awiqli if it has been frozen. Throw it away in a sharps disposal container if it has been frozen.
- Avoid exposing Awiqli to direct sunlight.
- Keep Awiqli away from heat, microwaves and out of the light.
- Keep the pen cap on when the pen is not in use.
- Keep the Awiqli FlexTouch pen and all medicines out of the reach of children.
Caring for your pen
- Treat your pen with care. Rough handling or misuse may cause incorrect dosing, which can lead to too high or too low blood sugar levels.
- Do not drop your pen or knock it against hard surfaces.
- Do not try to repair your pen or pull it apart.
- Do not expose your pen to dust, dirt, or liquid.
- Do not wash, soak, or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth.
- After you have taken your first injection, your pen should be thrown away (disposed of) after 12 weeks, even if it still has Awiqli left in it. Write the disposal date on your calendar.
- Unused Awiqli FlexTouch pens may be used until the expiration date (‘EXP’) printed on the label, if kept in the refrigerator.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License No. 1261
At: Novo Nordisk A/S
Novo Allé
2880 Bagsvaerd
Denmark
For information about Awiqli, contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-844-668-6463
Novo Nordisk®, Awiqli®, FlexTouch®, NovoFine® and NovoFine® Plus are registered trademarks of Novo Nordisk A/S.
Patent Information: http://novonordisk-us.com/products/product-patents.html
© 2026 Novo Nordisk
- This Instructions for Use has been approved by the U.S. Food and Drug Administration Issued: 03/2026