Levemir (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

LEVEMIR is available as a clear and colorless solution containing 100 units of insulin detemir per mL (U-100) in the following presentations:

Presentation

Total Volume

NDC

Single-patient-use FlexTouch pen

3 mL

0169-6438-10

Multiple-dose vial

10 mL

0169-3687-12

FlexTouch can be used with NovoFine® or NovoTwist® disposable needles. Each FlexTouch is for use by a single patient. LEVEMIR FlexTouch must never be shared between patients, even if the needle is changed.

LEVEMIR FlexTouch dials in 1-unit increments.

16.2 Storage

Dispense in the original sealed carton with the enclosed Instructions for Use.

Unused (unopened) LEVEMIR should be stored in the refrigerator between 36° to 46°F (2° and 8°C). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use LEVEMIR if it has been frozen. Keep unused LEVEMIR in the carton so that it stays clean and protected from light.

Remove the needle from the LEVEMIR FlexTouch pen after each injection and store without a needle attached. Use a new needle for each injection.

The storage conditions for vials and LEVEMIR FlexTouch pens are summarized in Table 12:

Table 12: Storage Conditions for LEVEMIR FlexTouch and Vial

LEVEMIR

Presentation

Not in-use (unopened)

In-use (opened)

Refrigerated

(36° to 46°F

[2° and 8°C])

Room

Temperature

(below 86°F [30°C])

Refrigerated

(36° to 46°F

[2° and 8°C])

Room

Temperature (below 86°F [30°C])

3 mL single-patient-use LEVEMIR FlexTouch pen

Until expiration date

42 days

Do not refrigerate

42 days

10 mL multiple-dose vial

Until expiration date

42 days

42 days

42 days

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Patient Information and Instructions for Use)

Never Share a LEVEMIR FlexTouch between Patients

Advise patients that they must never share a LEVEMIR FlexTouch pen with another person, even if the needle is changed. Advise patients using LEVEMIR 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)].

Hypoglycemia

Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of LEVEMIR 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.

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 [see Warnings and Precautions (5.3)].

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions have occurred with LEVEMIR. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.5)].

Medication Errors

Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions (5.4)].

Novo Nordisk ® , Levemir ® , NovoLog ® , FlexTouch® , NovoFine® , and NovoTwist® are registered trademarks of Novo Nordisk A/S.

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

© 2005-2020 Novo Nordisk

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

For information about LEVEMIR contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, New Jersey 08536

1-800-727-6500

www.novonordisk-us.com

Patient Information

Patient Information

LEVEMIR® (LEV–uh-mere)

(insulin detemir injection)

Do not share your Levemir FlexTouch 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 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 meant for use to treat diabetic ketoacidosis.

Who should not take Levemir?

Do not take Levemir if you:

have an allergy to Levemir or any of the ingredients in Levemir.

Before taking Levemir, 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 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 come 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).
Never 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.
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 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). Signs and symptoms that may indicate low blood sugar include:

dizziness or light-headedness
sweating
confusion
headache
blurred vision
slurred speech
shakiness
fast heart beat
anxiety, irritability, or mood changes
hunger

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

Other common side effects of Levemir may include:

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:

trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

These are not all the possible side effects of Levemir. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are the ingredients in Levemir?

Active Ingredient: insulin detemir

Inactive Ingredients: zinc, m-cresol, glycerol, phenol, disodium phosphate dihydrate, sodium chloride and water for injection. Hydrochloric acid or sodium hydroxide may be added.

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

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: 11/2019

Patient Instructions For Use

LEVEMIR ® 10 mL multiple-dose vial

Please read the following Instructions for use carefully before using your LEVEMIR® 10 mL vial and each time you get a refill. You should read the instructions in this manual even if you have used an insulin 10 mL vial before.

How should I use the LEVEMIR 10 mL vial?

Using the 10 mL vial:

1. Check to make sure that you have the correct type of insulin. This is especially important if you use different types of insulin.

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.

3. Wash your hands with soap and water.

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.

Figure 4AFigure 4B

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.

6. Pull back the plunger on your syringe until the black tip reaches the marking for the number of units you will inject.

Figure 6

7. Push the needle through the rubber stopper into the vial.

Figure 7

8. Push the plunger all the way in. This inserts air into the vial.

Figure 8

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.

Figure 9

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.

Figure 10

11. Check to make sure you have the right dose of LEVEMIR in the syringe.

12. Pull the syringe out of the vial.

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. 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.

Figure 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.

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.

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

Revised: 11/2019

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

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

© 2005-2019 Novo Nordisk

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

For information about LEVEMIR® contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, New Jersey 08536

Instructions for Use

Levemir® (LEV–uh-mere) FlexTouch® Pen

(insulin detemir injection)

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 pen containing 300 units of U-100 Levemir (insulin detemir injection) insulin. 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.

Needle components.
(click image for full-size original)
Figure A FlexTouch pen components.
(click image for full-size original)

Step 1:

Pull Pen cap straight off (See Figure B).
Step 1 Fig B.jpg

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 2 Fig C.jpg

Step 3:

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

Step 4:

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

Figure E

Step 5:

Pull off the outer needle cap. Do no t throw it away (See Figure F).

Figure F

Step 6:

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

Figure G

Priming your Levemir FlexTouch Pen:

Step 7:

Turn the dose selector to select 2 units (See Figure H).
Step 7 Fig H.jpg

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 8 Fig I.jpg

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).

o
If you do not see a drop of insulin, repeat steps 7 to 9, no more than 6 times.
o
If you still do not see a drop of insulin, change the needle and repeat steps 7 to 9.
Step 9 Fig J.jpg
(click image for full-size original)

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).
o
If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
o
The even numbers are printed on the dial.
o
The odd numbers are shown as lines.
Step 10 Fig K.jpg
(click image for full-size original)
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:
o
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.
o
If the dose counter shows less than 80, the number shown in the dose counter is the number of units left in your Pen.
Step 10 Fig L
(click image for full-size original)

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 and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure M).
Step 11 Fig M
(click image for full-size original)

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.
Step 12 Fig N.jpg

Step 13:

Press and hold down the dose button until the dose counter shows “0” (See Figure O).
o
The “0” must line up with the dose pointer. You may then hear or feel a click.
Step 13 Fig O.jpg
Keep the needle in your skin after the dose counter has returned to “0” and slowly count to 6 (See 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 13 Fig P.jpg

Step 14:

Pull the needle out of your skin (See Figure Q).
o
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 14 Fig Q.jpg

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.
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.
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 15 Figure RStep 15 Fig S.jpg

Step 16:

Replace the Pen cap by pushing it straight on (See Figure T).
Step 16 Fig T.jpg

After your injection:

You can put your used Levemir 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:
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.

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 below 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 A/S
DK-2880 Bagsvaerd, Denmark

Revised: 11/2019

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For more information go to

www.novotraining.com/levemirflextouch/us02

© 2005-2019 Novo Nordisk

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