Patient information: uses, side effects, how to take - Insulin Degludec
What is Insulin Degludec?
- Insulin Degludec is a man-made insulin that is used to control high blood sugar in adults and children who are 1 year of age and older with diabetes mellitus.
- Insulin Degludec is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
It is not known if Insulin Degludec is safe and effective in children under 1 year of age.
Insulin Degludec is available in 2 concentrations (U-100 and U-200):
U-100 concentration is available in pen and vial
- The 100 units/mL pen can be injected from 1 to 80 units in a single injection, in increments of 1 unit.
- The 100 units/mL vial should be used with a U-100 insulin syringe only.
U-200 concentration is only available in pen
- The 200 units/mL pen can be injected from 2 to 160 units in a single injection, in increments of 2 units.
Who should not take Insulin Degludec?
Do not take Insulin Degludec if you:
- are having an episode of low blood sugar (hypoglycemia).
- have an allergy to Insulin Degludec or any of the ingredients in Insulin Degludec.
Before taking Insulin Degludec, tell your healthcare provider about all your medical conditions including, if you are:
- pregnant, planning to become pregnant, or are breastfeeding.
- taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.
Before you start taking Insulin Degludec, talk to your healthcare provider about low blood sugar and how to manage it.
How should I take Insulin Degludec?
- Read the Instructions for Use that come with your Insulin Degludec.
- Take Insulin Degludec 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. Both the 100 units/mL and 200 units/mL Insulin Degludec 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.
- For children who need less than 5 units of Insulin Degludec each day, use a Insulin Degludec U-100 vial.
Adults: If you miss or are delayed in taking your dose of Insulin Degludec:
- Take your dose as soon as you remember then continue with your regular dosing schedule.
- Make sure there are at least 8 hours between your doses.
If children miss a dose of Insulin Degludec:
- Call the healthcare provider for information and instructions about checking blood sugar levels more often until the next scheduled dose of Insulin Degludec.
- Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
- 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.
- Never inject Insulin Degludec into a vein or muscle.
- Never use a syringe to remove Insulin Degludec from the FlexTouch pen.
- Insulin Degludec 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.
What should I avoid while taking Insulin Degludec?
While taking Insulin Degludec do not:
- Drive or operate heavy machinery, until you know how Insulin Degludec affects you.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
What are the possible side effects of Insulin Degludec?
Insulin Degludec 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
- Low potassium in your blood (hypokalemia).
- Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Insulin Degludec 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 Insulin Degludec. Your healthcare provider should monitor you closely while you are taking TZDs with Insulin Degludec. 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 Insulin Degludec 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
- weight gain or loss
- increased stress
- illness
- change in diet
Common side effects of Insulin Degludec may include:
- 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 Insulin Degludec. 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 Insulin Degludec.
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 Insulin Degludec that is written for health professionals. Do not use Insulin Degludec for a condition for which it was not prescribed. Do not give Insulin Degludec to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in Insulin Degludec?
Active Ingredient: insulin degludec
Inactive Ingredients: glycerin, metacresol, phenol, zinc, and Water for Injection, USP. Hydrochloric acid or sodium hydroxide may be added.
Manufactured by:
Novo Nordisk Inc., Plainsboro, NJ 08536, U.S. License Number 1261
For more information call 1-800-727-6500.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 07/2022
INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE
Insulin Degludec
injection, for subcutaneous use
10 mL multiple-dose vial (100 units/mL, U-100)
This product is Tresiba (insulin degludec).
Read this Instructions for Use before you start taking Insulin Degludec and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
The vial is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product and insulin syringe.
Do not reuse or share syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.
Supplies you will need to give your Insulin Degludec injection:
- a 10 mL Insulin Degludec vial
- a U-100 insulin syringe and needle
- 2 alcohol swabs
- 1 sharps container for throwing away used syringes and needles. See “Disposing of your used needles and syringes” at the end of these instructions.
Preparing your Insulin Degludec dose:
- Do not roll or shake the Insulin Degludec vial. Shaking the Insulin Degludec vial right before the dose is drawn into the syringe may cause bubbles or foam. This can cause you to draw up the wrong dose of insulin.
- The tamper-resistant cap should not be loose or damaged before the first use. Do not use if the tamper-resistant cap is loose or damaged before using Insulin Degludec for the first time.
- Wash your hands with soap and water.
- Before you start to prepare your injection, check the Insulin Degludec label to make sure that you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
- Check that the Insulin Degludec vial is not cracked or damaged. Do not use if the Insulin Degludec vial is cracked or damaged.
- Insulin Degludec should look clear and colorless. Do not use Insulin Degludec if it is thick, cloudy, or is colored.
- Do not use Insulin Degludec past the expiration date printed on the label or 56 days after you start using the Insulin Degludec vial.
Step 1: Pull off the tamper-resistant cap (See Figure A). Step 2: Wipe the rubber stopper with an alcohol swab (See Figure B). |  (Figure A Figure B) |
| Step 3: Hold the syringe with the needle pointing up. Pull down on the plunger until the tip of the plunger reaches the line for the number of units for your prescribed dose (See Figure C). |  (Figure C) |
| Step 4: Push the needle through the rubber stopper of the Insulin Degludec vial (See Figure D). |  (Figure D) |
| Step 5: Push the plunger all the way in. This puts air into the Insulin Degludec vial (See Figure E). |  (Figure E) |
Step 6: Turn the Insulin Degludec vial and syringe upside down and slowly pull the plunger down until the tip of the plunger is a few units past the line for your dose (See Figure F). If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top (See Figure G). |  (Figure F)  (Figure G) |
| Step 7: Slowly push the plunger up until the tip of the plunger reaches the line for your prescribed Insulin Degludec dose (See Figure H). |  (Figure H) |
| Step 8: Check the syringe to make sure you have the right dose of Insulin Degludec. | |
| Step 9: Pull the syringe out of the rubber stopper on the Insulin Degludec vial (See Figure I). |  (Figure I) |
- Giving your Insulin Degludec injection:
- • Inject your Insulin Degludec exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
- • Insulin Degludec can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen). Do not inject Insulin Degludec into your muscle.
- • Change (rotate) your injection sites within the area you choose for 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 same injection site 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.
- • Do not dilute or mix Insulin Degludec with any other type of insulin or solutions.
Step 10: Choose your injection site (thighs, upper arms, or abdomen) and wipe the skin with an alcohol swab (See Figure J). Let the injection site dry before you inject your dose. |  (Figure J) |
Step 11: Insert the needle into your skin. Push down on the plunger to inject your dose (See Figure K). Make sure you have injected all the insulin in the syringe. |  (Figure K) |
Step 12: Pull the needle out of your skin. After your injection, you may see a drop of Insulin Degludec at the needle tip. This is normal and does not affect the dose you just received (See Figure L).
|  (Figure L) |
After your injection:
- Do not recap the needle. Recapping the needle can lead to needle stick injury.
Disposing of your used needles and syringes:
Put your used insulin needles and syringes 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
- 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 reuse or share needles or syringes with another person. 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.
How should I store Insulin Degludec?
Before use:
- Store unopened Insulin Degludec vials in the refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
- Do not freeze Insulin Degludec. Do not use Insulin Degludec if it has been frozen.
- Unused Insulin Degludec vials may be used until the expiration date printed on the label, if they are kept in the refrigerator.
- After 56 days, throw away Insulin Degludec vials that have been kept at room temperature (up to 86°F (30°C)).
Vial in use:
- Store the Insulin Degludec vial you are currently using in the refrigerator between 36°F to 46°F (2°C to 8°C) or keep at room temperature up to 86°F (30°C) in the original carton to protect from light.
- Keep Insulin Degludec away from direct heat or light.
- The Insulin Degludec vial you are using should be thrown away after 56 days, even if it still has insulin left in it and the expiration date has not passed.
General information about the safe and effective use of Insulin Degludec
- Keep Insulin Degludec vials, syringes, and needles out of the reach of children.
- Always use a new syringe and needle for each injection to help ensure sterility and prevent blocked needles.
- Do not reuse or share syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License Number 1261
Novo Nordisk® is a registered trademark of Novo Nordisk A/S.
Patent Information:
http://novonordisk-us.com/products/product-patents.html
Revised: 07/2022
© 2022 Novo Nordisk
For information contact:
- Novo Nordisk Pharma, Inc.
1-800-727-6500
(Se habla español)
Read before first use
INSTRUCTIONS FOR USE
Insulin Degludec
injection, for subcutaneous use
FlexTouch® Pen 100 units/mL
This product is Tresiba (insulin degludec).
Please read the following instructions carefully before using your Insulin Degludec FlexTouch Pen.
- Do not share your Insulin Degludec FlexTouch Pen with other people, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them.
- Insulin Degludec FlexTouch Pen 100 units/mL (“Pen”) is a prefilled disposable, single-patient-use insulin pen containing 300 units of insulin degludec. You can inject from 1 to 80 units in a single injection. The units can be increased by 1 unit at a time.
- This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.
Supplies you will need to give your Insulin Degludec injection:
- Insulin Degludec FlexTouch Pen
- a new NovoFine or NovoTwist needle
- alcohol swab
- a sharps container for throwing away used Pens and needles. See “After your injection” at the end of these instructions.
Preparing your Insulin Degludec FlexTouch Pen:
- Wash your hands with soap and water.
- Before you start to prepare your injection, check the Insulin Degludec FlexTouch Pen label to make sure you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin.
- Insulin Degludec should look clear and colorless. Do not use Insulin Degludec if it is cloudy or colored.
- Do not use Insulin Degludec past the expiration date printed on the label or 56 days after you start using the Pen.
- Always use a new needle for each injection to help ensure sterility and prevent blocked needles. Do not reuse or share needles with another person. You may give other people a serious infection, or get a serious infection from them.
Step 1:
- Pull Pen cap straight off (See Figure B).
Step 2:
- Check the liquid in the Pen (See Figure C). Insulin Degludec should look clear and colorless. Do not use it if it looks cloudy or colored.
Step 3:
- Select a new needle.
- Pull off the paper tab from the outer needle cap (See Figure D).
Step 4:
- Push the capped needle straight onto the Pen and twist the needle on until it is tight (See Figure E).
Step 5:
- Pull off the outer needle cap. Do not throw it away (See Figure F).
Step 6:
- Pull off the inner needle cap and throw it away (See Figure G).
Priming your Insulin Degludec FlexTouch Pen:
Step 7:
- Turn the dose selector to select 2 units (See Figure H).
Step 8:
- Hold the Pen with the needle pointing up. Tap the top of the Pen gently a few times to let any air bubbles rise to the top (See Figure I).
Step 9:
- Hold the Pen with the needle pointing up. 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 insulin should be seen at the needle tip (See Figure J).
- If you do not see a drop of insulin, repeat steps 7 to 9, no more than 6 times.
- If you still do not see a drop of insulin, change the needle and repeat steps 7 to 9.
Selecting your dose:
Step 10:
Insulin Degludec FlexTouch Pen 100 units/mL is made to deliver the number of insulin units that your healthcare provider prescribed. Do not perform any dose conversion.
Check to make sure the dose selector is set at 0.
- Turn the dose selector to select the number of units you need to inject. The dose pointer should line up
with your dose (See Figure K).
- If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
- The even numbers are printed on the dial.
- The odd numbers are shown as lines.
- The Insulin Degludec FlexTouch Pen insulin scale will show you how much insulin is left in your Pen (See Figure L).
- To see how much insulin is left in your Insulin Degludec FlexTouch Pen:
- Turn the dose selector until it stops. The dose counter will line up with the number of units of insulin that is left in your Pen. If the dose counter shows 80, there are at least 80 units left in your Pen.
- If the dose counter shows less than 80, the number shown in the dose counter is the number of units left in your Pen.
Giving your injection:
- Inject your Insulin Degludec exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
- Insulin Degludec 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 for 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 same injection site 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.
Step 11:
- Choose your injection site (thighs, upper arms, or abdomen) and wipe the skin with an alcohol swab (See Figure M). Let the injection site dry before you inject your dose.
Step 12:
- Insert the needle into your skin (See Figure N).
- Make sure you can see the dose counter. Do not cover it with your fingers, this can stop your injection.
Step 13:
- Press and hold down the dose button until the dose counter shows “0” (See Figure O).
- The “0” must line up with the dose pointer. You may then hear or feel a click.
- Keep the needle in your skin after the dose counter has returned to “0” and slowly count to 6 (See Figure P).
- When the dose counter returns to “0”, you will not get your full dose until 6 seconds later.
- If the needle is removed before you count to 6, you may see a stream of insulin coming from the needle tip.
- If you see a stream of insulin coming from the needle tip you will not get your full dose. If this happens you should check your blood sugar levels more often because you may need more insulin.
Step 14:
- Pull the needle out of your skin (See Figure Q).
- If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.
Step 15:
- Carefully remove the needle from the Pen and throw it away (See Figure R).
- Do not recap the needle. Recapping the needle can lead to needle stick injury.
- If you do not have a sharps container, carefully slip the needle into the outer needle cap (See Figure S). Safely remove the needle and throw it away as soon as you can.
- Do not store the Pen with the needle attached. Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.
Step 16:
- Replace the Pen cap by pushing it straight on (See Figure T).
After your injection:
- The used Insulin Degludec FlexTouch Pen may be thrown away in your household trash after you have removed the needle.
- Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) 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
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
- upright and stable during use
- leak-resistant
- 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 reuse or share needles or syringes with another person. For more information about the 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.
How should I store my Insulin Degludec FlexTouch Pen?
Before use:
- Store unused Insulin Degludec FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Do not freeze Insulin Degludec. Do not use Insulin Degludec if it has been frozen.
- Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.
Pen in use:
- Store the Pen you are currently using in the refrigerator between 36°F to 46°F (2°C to 8°C) or keep at room temperature up to 86°F (30°C).
- Keep Insulin Degludec away from heat or light.
- The Insulin Degludec FlexTouch Pen you are using should be thrown away after 56 days if it is refrigerated or kept at room temperature, even if it still has insulin left in it and the expiration date has not passed.
General Information about the safe and effective use of Insulin Degludec.
- Keep Insulin Degludec FlexTouch Pens and needles out of the reach of children.
- Always use a new needle for each injection.
- Do not share Insulin Degludec FlexTouch Pens or needles with other people. You may give other people a serious infection, or get a serious infection from them.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License Number 1261
For information contact:
Novo Nordisk Pharma, Inc.
1-800-727-6500 (Se habla español)
Revised: 07/2022
© 2022 Novo Nordisk
INSTRUCTIONS FOR USE
Insulin Degludec
injection, for subcutaneous use
FlexTouch® Pen 200 units/mL
This product is Tresiba (insulin degludec).
Please read the following instructions carefully before using your Insulin Degludec FlexTouch Pen.
- Do not share your Insulin Degludec FlexTouch Pen with other people, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them.
- Insulin Degludec FlexTouch Pen 200 units/mL (“Pen”) is a prefilled disposable, single-patient-use insulin pen containing 600 units of insulin degludec. You can inject from 2 to 160 units in a single injection. The units can be increased by 2 units at a time.
- Do not use a syringe to remove insulin from your Pen. If you do, you will get too many units of insulin because the scale on most syringes is for measuring U-100 insulin doses only.
- This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.
Supplies you will need to give your Insulin Degludec injection:
- Insulin Degludec FlexTouch Pen
- a new NovoFine or NovoTwist needle
- alcohol swab
- a sharps container for throwing away used Pens and needles. See “After your injection” at the end of these instructions.
Preparing your Insulin Degludec FlexTouch Pen:
- Wash your hands with soap and water.
- Before you start to prepare your injection, check the Insulin Degludec FlexTouch Pen label to make sure you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin.
- Insulin Degludec should look clear and colorless. Do not use Insulin Degludec if it is cloudy or colored.
- Do not use Insulin Degludec past the expiration date printed on the label or 56 days after you start using the Pen.
- Always use a new needle for each injection to help ensure sterility and prevent blocked needles. Do not reuse or share needles with another person. You may give other people a serious infection, or get a serious infection from them.
(Figure A)
Step 1:
- Pull Pen cap straight off (See Figure B).
Step 2:
- Check the liquid in the Pen (See Figure C). Insulin Degludec should look clear and colorless. Do not use it if it looks cloudy or colored.
Step 3:
- Select a new needle.
- Pull off the paper tab from the outer needle cap (See Figure D).
Step 4:
- Push the capped needle straight onto the Pen and twist the needle on until it is tight (See Figure E).
Step 5:
- Pull off the outer needle cap. Do not throw it away (See Figure F).
Step 6:
- Pull off the inner needle cap and throw it away (See Figure G).
Priming your Insulin Degludec FlexTouch Pen:
Step 7:
- Turn the dose selector to select 2 units (See Figure H).
Step 8:
- Hold the Pen with the needle pointing up. Tap the top of the Pen gently a few times to let any air bubbles rise to the top (See Figure I).
Step 9:
- Hold the Pen with the needle pointing up. 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 insulin should be seen at the needle tip (See Figure J).
- If you do not see a drop of insulin, repeat steps 7 to 9, no more than 6 times.
- If you still do not see a drop of insulin, change the needle and repeat steps 7 to 9.
Selecting your dose:
Step 10:
Insulin Degludec FlexTouch Pen 200 units/mL is made to deliver the number of insulin units that your healthcare provider prescribed. Do not perform any dose conversion.
Check to make sure the dose selector is set at 0.
- Turn the dose selector to select the number of units you need to inject. The dose pointer should line up
with your dose (See Figure K).
- If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
- Each line on the dial is an even number.
- The Insulin Degludec FlexTouch Pen insulin scale will show you how much insulin is left in your Pen (See Figure L).
- To see how much insulin is left in your Insulin Degludec FlexTouch Pen:
Turn the dose selector until it stops. The dose counter will line up with the number of units of insulin that is
left in your Pen. If the dose counter shows 160, there are at least 160 units left in your Pen.
- If the dose counter shows less than 160, the number shown in the dose counter is the number of units left in your Pen.
Giving your injection:
- Inject your Insulin Degludec exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
- Insulin Degludec 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 for 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 same injection site 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.
Step 11:
- Choose your injection site (thighs, upper arms, or abdomen) and wipe the skin with an alcohol swab (See Figure M). Let the injection site dry before you inject your dose.
Step 12:
- Insert the needle into your skin (See Figure N).
- Make sure you can see the dose counter. Do not cover it with your fingers, this can stop your injection.
Step 13:
- Press and hold down the dose button until the dose counter shows “0” (See Figure O).
- The “0” must line up with the dose pointer. You may then hear or feel a click.
- Keep the needle in your skin after the dose counter has returned to “0” and slowly count to 6 (See Figure P).
- When the dose counter returns to “0”, you will not get your full dose until 6 seconds later.
- If the needle is removed before you count to 6, you may see a stream of insulin coming from the needle tip.
- If you see a stream of insulin coming from the needle tip you will not get your full dose. If this happens you should check your blood sugar levels more often because you may need more insulin.
Step 14:
- Pull the needle out of your skin (See Figure Q).
- If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.
Step 15:
- Carefully remove the needle from the Pen and throw it away (See Figure R).
- Do not recap the needle. Recapping the needle can lead to needle stick injury.
- If you do not have a sharps container, carefully slip the needle into the outer needle cap (See Figure S). Safely remove the needle and throw it away as soon as you can.
- Do not store the Pen with the needle attached. Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.
Step 16:
- Replace the Pen cap by pushing it straight on (See Figure T).
After your injection:
- The used Insulin Degludec FlexTouch Pen may be thrown away in your household trash after you have removed the needle.
- Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) 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
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
- upright and stable during use
- leak-resistant
- 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 reuse or share needles or syringes with another person. For more information about the 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.
How should I store my Insulin Degludec FlexTouch Pen?
Before use:
- Store unused Insulin Degludec FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Do not freeze Insulin Degludec. Do not use Insulin Degludec if it has been frozen.
- Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.
Pen in use:
- Store the Pen you are currently using in the refrigerator between 36°F to 46°F (2°C to 8°C) or keep at room temperature up to 86°F (30°C).
- Keep Insulin Degludec away from heat or light.
- The Insulin Degludec FlexTouch Pen you are using should be thrown away after 56 days if it is refrigerated or kept at room temperature, even if it still has insulin left in it and the expiration date has not passed.
General Information about the safe and effective use of Insulin Degludec.
- Keep Insulin Degludec FlexTouch Pens and needles out of the reach of children.
- Always use a new needle for each injection.
- Do not share Insulin Degludec FlexTouch Pens or needles with other people. You may give other people a serious infection, or get a serious infection from them.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License Number 1261
For information contact:
Novo Nordisk Pharma, Inc.
1-800-727-6500 (Se habla español)
Revised: 07/2022
© 2022 Novo Nordisk