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Levemir (Insulin detemir): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
100 IU/mL
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Active ingredient:

Patient information: uses, side effects, how to take - Levemir

What is LEVEMIR?

  • LEVEMIR is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.
  • LEVEMIR is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Who should not take LEVEMIR?

Do not take LEVEMIR if you:

  • are having an episode of low blood sugar (hypoglycemia).
  • have an allergy to LEVEMIR or any of the ingredients in LEVEMIR. See the end of this Patient Information leaflet for a complete list of ingredients in LEVEMIR.

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

  • take any other medicines, especially medicines commonly called TZDs (thiazolidinediones).
  • are pregnant, planning to become pregnant, or are breastfeeding.

Tell your healthcare provider all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Before you start taking LEVEMIR, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take LEVEMIR?

  • Read the Instructions for Use that comes with your LEVEMIR.
  • Take LEVEMIR exactly as your healthcare provider tells you to.
  • 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.
  • 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 or syringes with other people. You may give other people a serious infection or get a serious infection from them.
  • LEVEMIR is injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
  • Do not inject LEVEMIR into a vein or muscle.
  • 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 LEVEMIR?

While taking LEVEMIR do not:

  • Drive or operate heavy machinery, until you know how LEVEMIR affects you.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of LEVEMIR?

LEVEMIR may cause serious side effects that can lead to death, including:

  • low blood sugar (hypoglycemia). Low blood sugar can be a serious, but common side effect of LEVEMIR. Signs and symptoms that may indicate low blood sugar include:
  • dizziness or light-headedness
  • sweating
  • confusion
  • headache
  • blurred vision
  • slurred speech
  • shakiness
  • fast heartbeat
  • anxiety, irritability, or mood changes
  • hunger
  • severe allergic reactions. Severe allergic reactions are a potential side effect of LEVEMIR. Get emergency medical help if you have:
  • trouble breathing
  • shortness of breath
  • fast heartbeat
  • swelling
  • swelling of your face, tongue, or throat
  • sweating
  • extreme drowsiness
  • dizziness
  • confusion
  • low potassium in your blood (hypokalemia).
  • heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with LEVEMIR 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 LEVEMIR. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
  • shortness of breath
  • swelling of ankles or feet
  • sudden weight gain

Treatment with TZDs and LEVEMIR may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.

Other common side effects of LEVEMIR include:

  • injection site reactions
  • skin thickening or pits at the injection site (lipodystrophy)
  • weight gain
  • swelling of your hands and feet
  • rash
  • itching

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

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of LEVEMIR. 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 LEVEMIR.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use LEVEMIR for a condition for which it was not prescribed. Do not give LEVEMIR to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about LEVEMIR that is written for health professionals.

What are the ingredients in LEVEMIR?

Active Ingredient: insulin detemir

Inactive Ingredients: dibasic sodium phosphate, glycerin, metacresol, phenol, sodium chloride, zinc and Water for Injection, USP. Hydrochloric acid or sodium hydroxide may be added.

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License Number 1261

For more information, go to www.novonordisk-us.com or call 1-800-727-6500.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 12/2022

INSTRUCTIONS FOR USE

LEVEMIR ® (LEV-uh-mere)

injection, for subcutaneous use

10 mL multiple-dose vial

Please read the following Instructions for use carefully before using your LEVEMIR® vial and each time you get a refill. You should read the instructions in this manual even if you have used an insulin vial before.

How should I use the LEVEMIR vial?

Using the vial:

  1. 1. Check to make sure that you have the correct type of insulin. This is especially important if you use different types of insulin.
  1. 2. Look at the vial and the insulin. The LEVEMIR insulin should be clear and colorless. The tamper-resistant cap should be in place before the first use. If the cap has been removed before your first use of the vial, or if the insulin is cloudy or colored, do not use the insulin and return it to your pharmacy.
  1. 3. Wash your hands with soap and water.
  1. 4. If you are using a new vial, pull off the tamper-resistant cap.

Before each use, wipe the rubber stopper with an alcohol wipe.

  1. 5. Do not roll or shake the vial. Shaking the 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 insulin should be used only if it is clear and colorless.
  1. 6. Pull back the plunger on your syringe until the black tip reaches the marking for the number of units you will inject.
  1. 7. Push the needle through the rubber stopper into the vial.
  1. 8. Push the plunger all the way in. This inserts air into the vial.
  1. 9. Turn the vial and syringe upside down and slowly pull the plunger back to a few units beyond the correct dose that you need.
  1. 10. If there are air bubbles, tap the syringe gently with your finger to raise the air bubbles to the top of the needle. Then slowly push the plunger to the correct unit marking for your dose.
  1. 11. Check to make sure you have the right dose of LEVEMIR in the syringe.
  1. 12. Pull the syringe out of the vial.
  1. 13. Inject your LEVEMIR right away as instructed by your healthcare provider. LEVEMIR can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs) or upper arms. For each injection, change (rotate) your injection site within the area of skin that you use 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.

How should I inject LEVEMIR with a syringe?

If you clean your injection site with an alcohol swab, let the injection site dry before you inject. Talk with your healthcare provider about how to rotate injection sites and how to give an injection.

  1. 1. Pinch your skin between two fingers, push the needle into the skinfold, using a dart-like motion and push the plunger to inject the insulin under your skin. The needle will be straight in.
  1. 2. Keep the needle under your skin for at least 6 seconds to make sure you have injected all the insulin. After you pull the needle from your skin you may see a drop of LEVEMIR at the needle tip. This is normal and has no effect on the dose you just received.
  1. 3. If blood appears after you pull the needle from your skin, press the injection site lightly with an alcohol swab. Do not rub the area.
  1. 4. After each injection, remove the needle without recapping and dispose of it in a puncture-resistant container. Used vials, syringes, needles, and lancets should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.

How should I store LEVEMIR?

  • Do not freeze LEVEMIR. Do not use LEVEMIR if it has been frozen.
  • Keep LEVEMIR away from heat or light.
  • All unopened vials:

    • Store unopened LEVEMIR vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
    • Unopened vials may be used until the expiration date printed on the label, if they have been stored in the refrigerator.
    • Unopened vials should be thrown away after 42 days, if they are stored at room temperature up to 86°F (30°C).
  • After vials have been opened:
  • Opened LEVEMIR vials can be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) or at room temperature up to 86°F (30°C).
  • Throw away all opened LEVEMIR vials after 42 days, even if they still have insulin left in them.

Revised: 07/2022

Novo Nordisk® and LEVEMIR® are registered trademarks of Novo Nordisk A/S.

PATENT Information: https://www.novonordisk-us.com/products/product-patents.html

© 2005-2022 Novo Nordisk

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License Number 1261

INSTRUCTIONS FOR USE

Levemir® (LEV–uh-mere)

(insulin detemir)

injection, for subcutaneous use

FlexTouch® Pen

Please read the following instructions carefully before using your Levemir FlexTouch Pen.

  • Do not share your Levemir FlexTouch 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.
  • Levemir FlexTouch Pen (“Pen”) is a prefilled disposable, single-patient-use insulin pen containing 300 units insulin detemir. You can inject from 1 to 80 units in a single injection.
  • People who are blind or have vision problems should not use this Pen without help from a person trained to use the Pen.

Supplies you will need to give your Levemir injection:

  • Levemir FlexTouch Pen
  • a new NovoFine, NovoFine Plus or NovoTwist needle
  • alcohol swab
  • 1 sharps container for throwing away used Pens and needles. See “Disposing of used Levemir FlexTouch Pens and needles” at the end of these instructions.

Preparing your Levemir FlexTouch Pen:

  • Wash your hands with soap and water.
  • Before you start to prepare your injection, check the Levemir 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.
  • Levemir should look clear and colorless. Do not use Levemir if it is thick, cloudy, or is colored.
  • Do not use Levemir past the expiration date printed on the label or 42 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 your needles with other people. 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). Levemir 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 Levemir 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:

  • 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 Levemir 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 Levemir 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 Levemir exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
  • Levemir can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs) or upper arms.
  • For each injection, change (rotate) your injection site within the area of skin that you use 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 (abdomen, thighs or upper arms) and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure M).

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 Levemir FlexTouch Pen may be thrown away in your household trash after you have removed the needle.
  • You can 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 your needles or syringes with other people. 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 my Levemir FlexTouch Pen?

  • Store unused Levemir FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Store the Pen you are currently using out of the refrigerator up to 86°F.
  • Do not freeze Levemir. Do not use Levemir if it has been frozen.
  • Keep Levemir away from heat or light.
  • Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.
  • The Levemir FlexTouch Pen you are using should be thrown away after 42 days, even if it still has insulin left in it.

General Information about the safe and effective use of Levemir:

  • Keep Levemir FlexTouch Pens and needles out of the reach of children.
  • Always use a new needle for each injection.
  • Do not share your Levemir FlexTouch Pen 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

Revised: 07/2022

For more information go to

www.novotraining.com/levemirflextouch/us02

© 2005-2022 Novo Nordisk

Levemir®

FlexTouch®

Read before first use

Instructions For Use

LEVEMIR® (LEV–uh-mere) FlexPen®

(insulin detemir)

injection, for subcutaneous use

Please read the following instructions carefully before using your LEVEMIR FlexPen.

Do not share your LEVEMIR FlexPen 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.

LEVEMIR FlexPen is a prefilled disposable, single-patient-use, insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. LEVEMIR FlexPen is designed to be used with NovoFine or NovoFine Plus needles.

People who are blind or have vision problems should not use this Pen without help from a person trained to use the Pen.

Getting ready

Make sure you have the following items:

  • LEVEMIR FlexPen
  • NovoFine or NovoFine Plus disposable needles
  • Alcohol swab
  • Sharps disposal container (see After the Injection)

Preparing your LEVEMIR FlexPen

Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin. LEVEMIR should look clear and colorless. Do not use LEVEMIR if it is thick, cloudy, or is colored.

A. Pull off the pen cap (see diagram A).

Wipe the rubber stopper with an alcohol swab.

B. Attaching the needle

Remove the protective tab from a new disposable needle.

Screw the needle tightly onto your FlexPen. It is important that the needle is put on straight (see diagram B).

Never place a disposable needle on your LEVEMIR FlexPen until you are ready to give your injection.

C. Pull off the big outer needle cap (see diagram C).
D. Pull off the inner needle cap and throw it away (dispose of it) (see diagram D).

Always use a new needle for each injection to make sure the needle is free of germs (sterile) and to prevent blocked needles. 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.

Be careful not to bend or damage the needle before use.

To reduce the risk of needle sticks, never put the inner needle cap back on the needle.

Giving the airshot before each injection

Before each injection, small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to ensure proper dosing:

E. Turn the dose selector to select 2 units (see diagram E).
F. Hold your LEVEMIR FlexPen with the needle pointing up. Tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (see diagram F).

G. Keep the needle pointing upwards, press the green push-button all the way in (see diagram G). The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

If you do not see a drop of insulin after 6 times, do not use the LEVEMIR FlexPen and contact Novo Nordisk at 1-800-727-6500.

A small air bubble may remain at the needle tip, but it will not be injected.

Selecting your dose

Check and make sure that the dose selector is set at 0.

H. Turn the dose selector to the number of units you need to inject. The pointer should line up with your dose.

The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer (see diagram H). When turning the dose selector, be careful not to press the green push-button as insulin will come out.

You cannot select a dose larger than the number of units left in the cartridge.

You will hear a click for every single unit dialed. Do not set the dose by counting the number of clicks you hear because you may get an incorrect dose.

Do not use the cartridge scale printed on the cartridge to measure your dose of insulin.

Giving the injection

Give the injection exactly as shown to you by your healthcare provider. Your healthcare provider should tell you if you need to pinch the skin before injecting. Wipe the skin with an alcohol swab and let the area dry.

LEVEMIR can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs), or upper arms.

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.

I. Insert the needle into your skin.

Inject the dose by pressing the green push-button all the way in until the 0 lines up with the pointer (see diagram I). Be careful only to push the green push-button when injecting.

Turning the dose selector will not inject the insulin.

J. Keep the needle in the skin for at least 6 seconds, and keep the green push-button pressed all the way in until the needle has been pulled out from the skin (see diagram J). This will make sure that the full dose has been given.

You may see a drop of insulin at the needle tip. This is normal and has no effect on the dose you just received. If blood appears after you take the needle out of your skin, press the injection site lightly with an alcohol swab. Do not rub the area.

After the injection

Do not recap the needle. Recapping can lead to a needle stick injury. Remove the needle from the LEVEMIR FlexPen after each injection and dispose of it. This helps to prevent infection, leakage of insulin, and will help to make sure you inject the right dose of insulin.

  • If you do not have a sharps container, carefully slip the needle into the outer needle cap using 1 hand. Use your other hand to pinch the base of the big outer needle cap and unscrew the used needle from the Pen and throw it away as soon as you can.
  • The used LEVEMIR FlexPen may be thrown away in your household trash after you have removed the needle.
  • Put your used needles in an 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, 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. 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.

When there is not enough medicine left in your LEVEMIR FlexPen for your prescribed dose, the LEVEMIR FlexPen may be thrown away in your household trash after you have removed the needle.

The LEVEMIR FlexPen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.

K. Put the pen cap on the LEVEMIR FlexPen and store the LEVEMIR FlexPen without the needle attached (see diagram K).

Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the LEVEMIR FlexPen.

How should I store LEVEMIR FlexPen?

  • Store the unused (unopened) LEVEMIR FlexPen in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Store the LEVEMIR FlexPen you are currently using out of the refrigerator up to 86°F.
  • Do not freeze the LEVEMIR FlexPen. Do not use the LEVEMIR FlexPen if it has been frozen.
  • Keep the LEVEMIR FlexPen away from heat or light.
  • Unused LEVEMIR FlexPens may be used until the expiration date printed on the label, if kept in the refrigerator.

The LEVEMIR FlexPen you are using should be thrown away after 42 days, even if it still has insulin left in it.

Keep your LEVEMIR FlexPen and needles out of the reach of children.

Maintenance

For the safe and proper use of your LEVEMIR FlexPen be sure to handle it with care. Avoid dropping your LEVEMIR FlexPen as it may damage it. If you are concerned that your LEVEMIR FlexPen is damaged, use a new one. You can clean the outside of your LEVEMIR FlexPen by wiping it with a damp cloth. Do not soak or wash your LEVEMIR FlexPen as it may damage it. Do not refill your LEVEMIR FlexPen.

Remove the needle from the LEVEMIR FlexPen after each injection. This helps to ensure sterility, prevent leakage of insulin, and will help to make sure you inject the right dose of insulin for future injections.

Be careful when handling used needles to avoid needle sticks and transfer of infectious diseases.

Use the LEVEMIR FlexPen exactly as your healthcare provider tells you to.

Do not share your LEVEMIR FlexPen or needles with other people. You may give other people a serious infection, or get a serious infection from them.

Always use a new needle for each injection.

Novo Nordisk is not responsible for harm due to using this insulin pen with products not recommended by Novo Nordisk.

As a precautionary measure, always carry a spare insulin delivery device in case your LEVEMIR FlexPen is lost or damaged.

Remember to keep the disposable LEVEMIR FlexPen with you. Do not leave it in a car or other location where it can get too hot or too cold.

© 2022 Novo Nordisk

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

Revised: 12/2022

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 021536 · View the label on DailyMed

Revision date stated in the text: July 2022

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Levemir

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Insulin Analog
Active ingredient Insulin detemir 100 IU/mL
Dosage form Injection, solution
Route Subcutaneous
Marketing status listed in the FDA NDC Directory
Company (applicant) NOVO NORDISK INC
FDA approval BLA 021536Biologics License Application (BLA) Approved June 16, 2005
Packages (NDC)
Package
100 IU/mL – 10 ml in 1 vial, glass / 1 in 1 carton NDC 50090-1276-0
100 IU/mL – 3 ml in 1 syringe, plastic / 5 in 1 carton NDC 50090-1475-0

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.