Insulin detemir

What it is used for

LEVEMIR is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use LEVEMIR is not recommended for the treatment of diabetic ketoacidosis. LEVEMIR is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis.

How to take it

Using the vial:

Storing it

• 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.

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:

Selecting your dose

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

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.

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:
• o made of a heavy-duty plastic,
• o can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• o upright and stable during use,
• o leak-resistant, and
• o 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.

• 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

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.

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.

Priming your Levemir FlexTouch Pen:

Selecting your dose:

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.

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:
  • o made of a heavy-duty plastic
  • o can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
  • o upright and stable during use
  • o leak-resistant
  • o 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.