NOVOLOG insulin aspart

Get an overview of NOVOLOG (insulin aspart injection, solution), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in NOVOLOG can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as NOVOLOG.

Drug Basics

Brand Name: NOVOLOG

Generic Name: INSULIN ASPART

Drug Type: HUMAN PRESCRIPTION DRUG

Route: INTRAVENOUS, SUBCUTANEOUS

Dosage Form: INJECTION, SOLUTION

Packager: A-S Medication Solutions

Data Current As Of: 2021-08-16

Indications and Usage (1)---------------------------------------03/2021

Warnings and Precautions (5.3, 5.4, 5.5, 5.6)-----------------03/2021

Indications & Usage

NOVOLOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

  • NOVOLOG is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus (1).

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Never Share a NOVOLOG FlexPen or a NOVOLOG FlexTouch, PenFill Cartridge or PenFill Cartridge Device between Patients

Advise patients that they must never share NOVOLOG FlexPen, NOVOLOG FlexTouch, PenFill cartridge or PenFill cartridge devices with another person even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens. Advise patients using NOVOLOG vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.1)].

Hyperglycemia or Hypoglycemia

Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of NOVOLOG therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia [see Warnings and Precautions (5.3)].

Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.

Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions (5.2)].

Hypoglycemia with Medication Errors

Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions (5.3)].

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions have occurred with NOVOLOG. Inform patients of the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.4)].

Patients Using Continuous Subcutaneous Insulin Pumps

  • Train patients in both intensive insulin therapy with multiple injections and in the function of their pump and pump accessories.
  • Instruct patients to replace insulin in the reservoir at least every 6 days; infusion sets and infusion set insertion sites should be changed at least every 3 days. NOVOLOG is recommended for use in any reservoir and infusion sets that are compatible with insulin and the specific pump. Please see recommended reservoir and infusion sets in the pump manual.
  • Instruct patients to discard insulin exposed to temperatures higher than 37°C (98.6°F).
  • Instruct patients to inform physician and select a new site for infusion if infusion site becomes erythematous, pruritic, or thickened.
  • Instruct patients of the risk of rapid hyperglycemia and ketosis due to pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin. If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their physician [see Warnings and Precautions (5) and How Supplied/Storage and Handling (16.2)].
  • Instruct patients of the risk of hypoglycemia from pump malfunction. If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their physician [see Warnings and Precautions (5) and How Supplied/Storage and Handling (16.2)].

Before using an insulin pump with NOVOLOG, read the pump label to make sure the pump has been evaluated with NOVOLOG.

Rx only

Date of Issue: 03/2021

Version: 28

Novo Nordisk®, NOVOLOG®, PenFill®, Novolin®, FlexPen®, FlexTouch®, NovoFine®, and NovoTwist® are registered trademarks of Novo Nordisk A/S.

ReliOn® is a registered trademark of Walmart Inc. and is used under license by Novo Nordisk Inc.

Patent Information: http://novonordisk-us.com/products/product-patents.html

© 2021 Novo Nordisk

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

1-800-727-6500

U.S. License Number 1261

For information about NOVOLOG contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

1-800-727-6500 (Se Habla español)

www.novonordisk-us.com

Patient Information

NovoLog® (NŌ-vō-log)

(insulin aspart) injection

Do not share your NovoLog FlexPen, NovoLog FlexTouch, PenFill cartridge or PenFill cartridge compatible insulin delivery device 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.

What is NovoLog?

  • NovoLog is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.

Who should not take NovoLog?

Do not take NovoLog if you:

  • are having an episode of low blood sugar (hypoglycemia).
  • have an allergy to NovoLog or any of the ingredients in NovoLog.

Before taking NovoLog, 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 NovoLog, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take NovoLog?

  • Read the Instructions for Use that come with your NovoLog.
  • Take NovoLog exactly as your healthcare provider tells you to.
  • NovoLog starts acting fast. You should eat a meal within 5 to 10 minutes after you take your dose of NovoLog.
  • 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 with other people. You may give other people a serious infection or get a serious infection from them.
  • NovoLog can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs) or upper arms, or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.
  • 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.
    • o Do not use the exact same spot for each injection.
    • o Do not inject where the skin has pits, is thickened, or has lumps.
    • o Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

What should I avoid while taking NovoLog?

While taking NovoLog do not:

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

What are the possible side effects of NovoLog?

NovoLog 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:

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

Other common side effects of NovoLog may include:

  • low potassium in your blood (hypokalemia), reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.

Get emergency medical help if you have:

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

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 NovoLog that is written for health professionals. Do not use NovoLog for a condition for which it was not prescribed. Do not give NovoLog to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in NovoLog?

Active Ingredient: insulin aspart

Inactive Ingredients: disodium hydrogen phosphate dihydrate, glycerin, metacresol, phenol, sodium chloride, zinc, and Water for Injection, USP. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

Manufactured by: Novo Nordisk Inc., 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: 3/2021

INSTRUCTIONS FOR USE

NovoLog® (NŌ-vō-log)

(insulin aspart) injection

10 mL multiple-dose vial (100 Units/mL, U-100)

Read this Instructions for Use before you start taking NovoLog 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.

Supplies you will need to give your NovoLog injection:

  • 10 mL NovoLog vial
  • insulin syringe and needle
  • alcohol swabs
image 05.jpg

Preparing your NovoLog dose:

  • Wash your hands with soap and water.
  • Before you start to prepare your injection, check the NovoLog 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.
  • NovoLog should look clear and colorless. Do not use NovoLog if it is thick, cloudy, or is colored.
  • Do not use NovoLog past the expiration date printed on the label.
image 06.jpg

Step 1: Pull off the tamper resistant cap (See Figure A).

Step 2: Wipe the rubber stopper with an alcohol swab (See Figure B).

image 07.jpg

Step 3: Hold the syringe with the needle pointing up. Pull down on the plunger until the black tip reaches the line for the number of units for your prescribed dose (See Figure C).

image 08.jpg

Step 4: Push the needle through the rubber stopper of the NovoLog vial (See Figure D).

image 09.jpg

Step 5: Push the plunger all the way in. This puts air into the NovoLog vial (See Figure E).

image 10.jpg

Step 6: Turn the NovoLog vial and syringe upside down and slowly pull the plunger down until the black tip is a few units past the line for your dose (See Figure F).

image 11.jpg

  • If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top (See Figure G).
image 12.jpg

Step 7: Slowly push the plunger up until the black tip reaches the line for your NovoLog dose (See Figure H).

image 13.jpg

Step 8: Check the syringe to make sure you have the right dose of NovoLog.

Step 9: Pull the syringe out of the vial’s rubber stopper (See Figure I).

image 14.jpg

  •   Giving your Injection:
  • Inject your NovoLog exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
  • NovoLog can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms, infused in an insulin pump (continuous subcutaneous infusion into an area of your body recommended in the instructions that come with your insulin pump), or given through a needle in your arm (intravenously) by your healthcare provider.
  • If you inject NovoLog, 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.
  • If you use NovoLog in an insulin pump, you should change your insertion site every 3 days. NovoLog should be given into an area of your body recommended in the instructions that come with your insulin pump. Change (rotate) your insertion sites within the area you choose for each insertion to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the insertion sites. Do not insert into the exact same spot for each insertion. Do not insert where the skin has pits, is thickened, or has lumps. Do not insert where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. The insulin in the reservoir should be changed at least every 6 days even if you have not used all of the insulin.
  • If you use NovoLog in an insulin pump, see your insulin pump manual for instructions or talk to your healthcare provider.
  • NPH insulin is the only type of insulin that can be mixed with NovoLog. Do not mix NovoLog with any other type of insulin.
  • NovoLog should only be mixed with NPH insulin if it is going to be injected right away under your skin (subcutaneously).
  • NovoLog should be drawn up into the syringe before you draw up your NPH insulin.
  • Talk to your healthcare provider if you are not sure about the right way to mix NovoLog and NPH insulin.

Step 10: Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure J).

image 15.jpg

(Figure J)

Step 11: Insert the needle into your skin. Push down on the plunger to inject your dose (See Figure K). The needle should remain in the skin for at least 6 seconds to make sure you have injected all the insulin.

image 16.jpg

Step 12: Pull the needle out of your skin. After that, you may see a drop of NovoLog at the needle tip. This is normal and does not affect the dose you just received (See Figure L).

  • 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.
image 17.jpg

After your injection:

  • Do not recap the needle. Recapping the needle can lead to a needle stick injury.
  • Put the empty insulin vials, used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes and needles in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • omade of a heavy-duty plastic,
    • ocan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • oupright and stable during use,
    • oleak-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.

How should I store NovoLog?

  • Do not freeze NovoLog. Do not use NovoLog if it has been frozen.
  • Keep NovoLog away from heat or light.
  • All unopened vials:
  • oStore unopened NovoLog vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • oUnopened vials may be used until the expiration date printed on the label, if they have been stored in the refrigerator.
  • oUnopened vials should be thrown away after 28 days, if they are stored at room temperature.
  • After vials have been opened:
  • oOpened NovoLog vials can be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C).
  • oThrow away all opened NovoLog vials after 28 days, even if they still have insulin left in them.

General information about the safe and effective use of NovoLog

  • Always use a new syringe and needle for each injection.
  • Do not share syringes or needles.
  • Keep NovoLog vials, syringes, and needles out of the reach of children.

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, New Jersey 08536

1-800-727-6500

U.S. License Number 1261

NovoLog® is a registered trademark of Novo Nordisk A/S.

Patent Information: http://novonordisk-us.com/products/product-patents.html

© 2021 Novo Nordisk

For information about NovoLog contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, New Jersey 08536

1-800-727-6500

www.novonordisk-us.com

Revised: 3/2021

INSTRUCTIONS FOR USE

NovoLog ® (NŌ-vō-log) PenFill® 3 mL cartridge 100 Units/mL (U-100)

(insulin aspart) injection

  • Do not share your PenFill cartridge or PenFill cartridge compatible insulin delivery device 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.
  • Your healthcare provider should show you or your caregiver how to inject NovoLog the right way before you inject it for the first time.
  • NovoLog PenFill cartridge 100 Units/mL is a prefilled, single-patient-use cartridge containing 300 units of NovoLog (insulin aspart injection) 100 Units/mL insulin.
  • After you insert the PenFill cartridge in your device, you can use it for multiple injections. Read the instruction manual that comes with your insulin delivery device for complete instructions on how to use the PenFill cartridge with the device.
  • People who are blind or have vision problems should not use this PenFill cartridge without help from a person trained to use the PenFill cartridge with the device.
  • If using a new NovoLog PenFill cartridge, start with Step 1.
  • If the NovoLog PenFill cartridge has already been used, start with Step 2.

Supplies you will need to give your NovoLog injection:

  • NovoLog PenFill cartridge
  • Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery device
  • 1 new NovoFine, NovoFine Plus, or NovoTwist needle
  • Alcohol swabs
  • Adhesive bandage
  • Cotton gauze
  • A sharps container for throwing away used PenFill cartridges and needles. See “After your injection” at the end of these instructions.
image 18.jpg

(Figure A)

How to use the NovoLog PenFill cartridge

  • Wash your hands with soap and water.
  • Before you start to prepare your injection, check the NovoLog PenFill cartridge label to make sure that it contains the insulin you need. This is especially important if you take more than 1 type of insulin.
  • The tamper-resistant foil should be in place before the first use. If the foil has been broken or removed before your first use of the cartridge, do not use it. Call Novo Nordisk at 1-800-727-6500.
  • Carefully look at the cartridge and the insulin inside it. Check that the NovoLog cartridge:
    • o is not damaged, for example cracked or leaking
    • o is not loose on the threaded end
  • NovoLog should look clear and colorless. Do not use NovoLog if it is cloudy or colored or if the threaded end is loose (See Figure B).
image 19.jpg

(Figure B)

Step 1:

  • Insert a 3 mL cartridge with the threaded end first into your Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery device (See Figure C).
  • If you drop your device, check the insulin cartridge for damage such as cracks or leaking. If your cartridge is damaged, throw it away and use a new one.
image 20.jpg

(Figure C)

Prepare your device with a new needle

Step 2:

  • Take a new needle, and tear off the paper tab. 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 attach a new needle to your device until you are ready to give your injection. Do not reuse or share your needles with other people. You may give others a serious infection, or get a serious infection from them.
  • Be careful not to bend or damage the needle before you use it.
  • Push the needle straight onto the device. Turn the needle clockwise until it is on tight (See Figure D).
image 21.jpg

(Figure D)

Step 3:

  • Pull off the outer needle cap (See Figure E). Do not throw it away. You will need it after the injection to safely remove the needle.
image 22.jpg

(Figure E)

Step 4:

  • Pull off the inner needle cap and throw it away (See Figure F). Do not try to put the inner needle cap back on the needle.
image 23.jpg

(Figure F)

A drop of insulin may appear at the needle tip. This is normal, but you must still check the insulin flow.

  •   Check the insulin flow

Step 5:

  • Small amounts of air may collect in the cartridge during normal use. You must do an airshot before each injection to avoid injecting air and to make sure you receive the prescribed dose of your medicine.
  • Do the airshot as described in the instruction manual that comes with your device.
  • Keep testing your Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery device until you see insulin at the needle tip. If you still do not see a drop of insulin after 6 times, change the needle and repeat this step. This makes sure that any air bubbles are removed and that insulin is getting through the needle (See Figure G).
image 24.jpg

(Figure G)

Select your dose

Step 6:

  • Check to make sure that the dose counter is set to 0.
  • Turn the dose selector clockwise to select the dose you need to inject (See Figure H). The pointer should line up with your dose. When turning the dose selector, be careful not to press the dose button as insulin will come out. 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.
  • Refer to your insulin delivery device manual if necessary.
image 25.jpg

(Figure H)

Inject your dose

Step 7:

  • Do 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.
  • NovoLog can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms (See Figure I).
image 26.jpg

  •  (Figure I)
  • 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.
  • Clean your injection site with an alcohol swab. Let your skin dry. Do not touch this area again before injecting.
  • Insert the needle into your skin. Press and hold down the dose button until the dose counter shows “0”. Continue to keep the dose button pressed and keep the needle in your skin and slowly count to 6 (see Figure J).
  • Remove the needle from your skin.
image 27.jpg

(Figure J)

You may see a drop of NovoLog at the needle tip after injecting. 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 a cotton gauze and cover with an adhesive bandage, if necessary. Do not rub the area.

After your injection

Step 8:

  • Lay your outer needle cap on a flat surface. Carefully, lead the needle tip into the outer needle cap without touching the needle (See Figure K) and push the outer needle cap completely on.
image 28.jpg

(Figure K)

  • Hold the black cartridge holder on the insulin delivery device and unscrew the needle counterclockwise (See Figure L).
image 29.jpg

(Figure L)

  • Throw away (dispose of) the needle in an FDA-cleared sharps container as your healthcare professional has instructed you.
  • Put your empty NovoLog PenFill cartridge and used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and PenFill cartridges in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • omade of a heavy-duty plastic,
    • ocan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • oupright and stable during use, and
    • oleak-resistant and properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share your needles or syringes with other people. 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.

Step 9:

  • Keep the 3 mL PenFill cartridge in the device. Do not store your device with a needle attached. This will prevent infection or leakage of insulin and will make sure that you receive the right dose of NovoLog.
  • Put the pen cap on your device after each use to protect the insulin from light (See Figure M).
image 30.jpg

(Figure M)

How should I store my NovoLog PenFill cartridge?

  • Do not freeze NovoLog. Do not use NovoLog if it has been frozen.
  • Keep NovoLog away from heat or light.
  • Store the NovoLog PenFill cartridge without the needle attached.

Before use:

  • Store unused NovoLog PenFill cartridges in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Unused PenFill cartridges may be used until the expiration date printed on the label, if kept in the refrigerator.
  • If NovoLog is stored mistakenly outside of refrigeration between 47°F (9°C) to 86°F (30°C) prior to first use, it should be used within 28 days or thrown away.

PenFill cartridges in use:

  • Store the PenFill cartridge you are currently using in the insulin delivery device at room temperature below 86°F (30°C) for up to 28 days. Do not refrigerate.
  • The NovoLog PenFill cartridge you are using should be thrown away after 28 days, even if it still has insulin left in it.

General Information about the safe and effective use of NovoLog.

  • Keep NovoLog PenFill cartridges and needles out of the reach of children.
  • Do not share NovoLog PenFill cartridges or needles with other people. You may give other people a serious infection, or get a serious infection from them.
  • Always carry extra insulin of the same type(s) you use in case of loss or damage.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

© 2021 Novo Nordisk

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License Number 1261

Revised: 03/2021

INSTRUCTIONS FOR USE

NovoLog® (NŌ-vō-log) FlexTouch® Pen

(insulin aspart) injection

  • Do not share your NovoLog FlexTouch Pen with other people, even if the needle has been is changed. You may give other people a serious infection, or get a serious infection from them.
  • NovoLog FlexTouch Pen (“Pen”) is a prefilled, single-patient-use disposable pen containing 300 units of U-100 NovoLog (insulin aspart injection) insulin. You can inject from 1 to 80 units in a single injection. The units can be increased by 1 unit at a time.
  • 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 NovoLog injection:

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

Preparing your NovoLog FlexTouch Pen:

  • Wash your hands with soap and water.
  • Before you start to prepare your injection, check the NovoLog 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.
  • NovoLog should look clear and colorless. Do not use NovoLog if it is thick, cloudy, or is colored.
  • Do not use NovoLog past the expiration date printed on the label or 28 days after you start using the Pen.

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 .

image 31.jpg

Step 1:

  • Pull Pen cap straight off (See Figure B).
image 32.jpg

(Figure B)

Step 2:

  • Check the liquid in the Pen (See Figure C). NovoLog should look clear and colorless. Do not use it if it looks cloudy or colored.
image 33.jpg

(Figure C)

Step 3:

  • Select a new needle.
  • Pull off the paper tab from the outer needle cap (See Figure D).
image 34.jpg

(Figure D)

Step 4:

  • Push the capped needle straight onto the Pen and twist the needle on until it is tight (See Figure E).
image 35.jpg

(Figure E)

Step 5:

  • Pull off the outer needle cap. Do not throw it away (See Figure F).
image 36.jpg

(Figure F)

Step 6:

  • Pull off the inner needle cap and throw it away (See Figure G).
image 37.jpg

(Figure G)

Priming your NovoLog FlexTouch Pen:

Step 7:

  • Turn the dose selector to select 2 units (See Figure H).
image 38.jpg

(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).
image 39.jpg

(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).
    • oIf you do not see a drop of insulin, repeat steps 7 to 9, no more than 6 times.
    • oIf you still do not see a drop of insulin, change the needle and repeat steps 7 to 9.
image 40.jpg

(Figure J)

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).
    • oIf you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
    • oThe even numbers are printed on the dial.
    • oThe odd numbers are shown as lines.
image 41.jpg

(Figure K)

  • The NovoLog FlexTouch Pen insulin scale will show you how much insulin is left in your Pen (See Figure L).
image 42.jpg

(Figure L)

  • To see how much insulin is left in your NovoLog FlexTouch Pen:
    • oTurn 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.
    • oIf 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 NovoLog exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
  • NovoLog can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, 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. For each injection, change (rotate) your injection site within the area of skin that you use. 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 and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure M).
image 43.jpg

(Figure M)

Step 12:

  • Insert the needle into your skin (See Figure N).
    • o Make sure you can see the dose counter. Do not cover it with your fingers, this can stop your injection.
image 44.jpg

(Figure N)

Step 13:

  • Press and hold down the dose button until the dose counter shows “0” (See Figure O).
    • oThe “0” must line up with the dose pointer. You may then hear or feel a click.
image 45.jpg

(Figure O)

  • Keep the needle in your skin after the dose counter has returned to “0” and slowly count to 6 (See Figure P).
image 46.jpg

(Figure P)

  •  
    • o When the dose counter returns to “0”, you will not get your full dose until 6 seconds later.
    • o If the needle is removed before you count to 6, you may see a stream of insulin coming from the needle tip.
    • o 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).
    • oIf 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.
image 47.jpg

(Figure Q)

Step 15:

  • Carefully remove the needle from the Pen and throw it away (See Figure R).
    • o Do not recap the needle. Recapping the needle can lead to needle stick injury.
image 48.jpg

(Figure R)

  • 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.
image 49.jpg

(Figure S)

  •  
    • o 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).
image 50.jpg

(Figure T)

After your injection:

  • You can put your used NovoLog FlexTouch Pen and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and Pens in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • omade of a heavy-duty plastic,
    • ocan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • oupright and stable during use, and
    • oleak-resistant and properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not 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 NovoLog FlexTouch Pen?

  • Do not freeze NovoLog. Do not use NovoLog if it has been frozen.
  • Keep NovoLog away from heat or light.
  • Store the NovoLog FlexTouch Pen without the needle attached.
  • Until first use:
  • oStore unused NovoLog FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • oUnused Pens may be used until the expiration date printed on the label, if kept in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • oUnused NovoLog FlexTouch Pen stored at room temperature should be thrown away after 28 days.
  • In-use:
  • oStore the Pen you are currently using out of the refrigerator at room temperature below 86°F.
  • oThe NovoLog FlexTouch Pen you are using should be thrown away after 28 days, even if it still has insulin left in it.

General Information about the safe and effective use of NovoLog.

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

image 51.jpg

Revised: 03/2021

For more information go to

www.novotraining.com/novologflextouch/us02

© 2021 Novo Nordisk

image 52.jpg

INSTRUCTIONS FOR USE

NovoLog® (NŌ-vō-log) FlexPen ®

(insulin aspart) injection

Introduction

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

Do not share your NovoLog 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.

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

  •  Δ 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:

  • NovoLog FlexPen
  • New NovoFine, NovoFine Plus or NovoTwist needle
  • Alcohol swabs
image 53.jpg

Preparing your NovoLog 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. NovoLog should look clear and colorless. Do not use your NovoLog FlexPen if the liquid contains particles or is colored.

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

image 54.jpg

Wipe the rubber stopper with an alcohol swab.

B. Attaching the needle

Remove the protective tab from a disposable needle.

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

image 55.jpg

Never place a disposable needle on your NovoLog FlexPen until you are ready to take your injection.

C. Pull off the big outer needle cap (see diagram C).

image 56.jpg

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

image 57.jpg

  •   Δ 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.
  •   Δ Be careful not to bend or damage the needle before use.
  •   Δ To reduce the risk of unexpected 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).

image 58.jpg

F. Hold your NovoLog 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).

image 59.jpg

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

image 60.jpg

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 NovoLog 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 push-button as insulin will come out.

image 61.jpg

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.

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

Giving the injection

Do 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.

NovoLog can be injected under the skin (subcutaneously) of your stomach area, buttocks, 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 push-button all the way in until the 0 lines up with the pointer (see diagram I). Be careful only to push the button when injecting.

image 62.jpg

Turning the dose selector will not inject insulin.

J. Keep the needle in the skin for at least 6 seconds, and keep the 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.

image 63.jpg

After the injection

Do not recap the needle. Recapping can lead to a needle stick injury.  Remove the needle from the NovoLog 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. Safely remove the needle and throw it away as soon as 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:
  • omade of a heavy-duty plastic,
  • ocan be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • oupright and stable during use,
  • oleak-resistant, and
  • oproperly 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 NovoLog FlexPen for your prescribed dose, the NovoLog FlexPen may be thrown away in your household trash after you have removed the needle. The NovoLog FlexPen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.

K. Put the pen cap on the NovoLog FlexPen and store the NovoLog 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 Pen.

image 64.jpg

How should I store NovoLog FlexPen?

  • Do not freeze NovoLog. Do not use NovoLog if it has been frozen.
  • Keep NovoLog away from heat or light.
  • Store the NovoLog FlexPen without the needle attached.
  • Until first use:
  • oStore unused NovoLog FlexPen in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • oUnused FlexPen may be used until the expiration date printed on the label, if kept in the refrigerator.
  • oUnused NovoLog FlexPen stored at room temperature should be thrown away after 28 days.
  • In-use:
  • oStore the FlexPen you are currently using out of the refrigerator at room temperature below 86°F (30°C) for up to 28 days.
  • oThe NovoLog FlexPen you are using should be thrown away after 28 days, even if it still has insulin left in it.

Maintenance

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

Δ Remove the needle from the NovoLog 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.

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

Δ Keep your NovoLog FlexPen and needles out of the reach of children.

Δ Use NovoLog FlexPen as directed to treat your diabetes.

Δ Do not share your NovoLog FlexPen or needles with other people. You may give other people a serious infection, or

get a serious infection from them.

Δ Always use a new needle for each injection.

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

Nordisk.

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

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

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, New Jersey 08536

1-800-727-6500

U.S. License Number 1261

Revised: 3/2021

Insulin Aspart

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Insulin Aspart

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Insulin Aspart

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also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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