Norditropin




PATIENT INFORMATION

Instructions for use

Norditropin® Cartridges
[somatropin (rDNA origin) injection]

Norditropin FlexPro Pen - Illustration

Overview Norditropin FlexPro Pen

Parts o -f the pen  Illustration

Pen cap

Pen cap - Illustration

Needle (example)

Needle - Illustration

Supplies you will need:

Norditropin FlexPro prefilled Pen

Novo Nordisk disposable needles up to a length of 8 mm

a sharps container

Supplies needed - Illustration

How to use your Norditropin FlexPro Pen

5 steps you should follow for a Norditropin injection:

Step 1: Prepare your Norditropin FlexPro Pen

Step 2: Check the Norditropin flow with each new Pen

Step 3: Select your dose

Step 4: Inject your dose

Step 5: After your injection

For further information about your Pen:

Frequently Asked Questions

Important information

Patient Information

Norditropin is for use under the skin only (subcutaneous).

Do not share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them.

Do not use your Pen without proper training from your healthcare provider.

Make sure that you are confident in making an injection with the Pen before you start your treatment. If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.

Step 1. Prepare your Norditropin FlexPro Pen

Wash your hands with soap and water.

Check the name, strength, and colored label on your Pen to make sure that it contains Norditropin in the right strength.

Pull off the Pen cap.

Turn the Pen upside down once or twice to check that the Norditropin in your Pen is clear and colorless. See figure A. If the Norditropin looks cloudy, do not use the Pen.

Figure A

Check pen is clear - Illustration

When you are ready to take your injection, take a new disposable needle, and tear off the paper tab.

Push the needle straight onto the Pen. Turn the needle clockwise until it is on tight. See figure B.

Figure B

Turn the needle clockwise - Illustration

Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing. • Pull off the outer needle cap and dispose of it. See figure C.

Figure C

Pull off the outer needle cap - Illustration

Pull off the inner needle cap and dispose of it. See figure D.

A drop of Norditropin may appear at the needle tip. This is normal, but you must still check the Norditropin flow with each new Pen. See step 2.

Figure D

Pull off the inner needle cap - Illustration

Never use a bent or damaged needle.

Step 2. Check the Norditropin flow with each new Pen

If your Pen is already in use, proceed to step 3.

Before using a new Pen, check the Norditropin flow to make sure the growth hormone can flow through the Pen and needle.

Turn the dose selector clockwise one tick mark to select 0.1 mg. You will hear a faint click. See figure E.

Figure E

Turn the dose selector - Illustration

One tick mark equals 0.1 mg in the dose counter. See figure F.

Figure F

One tick mark equals 0.1 mg - Illustration

Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer. See figure G.

Figure G

Align the dose pointer - Illustration

Check that a drop of Norditropin appears at the needle tip. See figure H.

If no Norditropin appears, repeat step 2 up to 6 times.

If you still do not see a drop of Norditropin, change the needle and repeat step 2 again.

Do not use the Pen if a drop of Norditropin still does not appear after repeating step 2. Call Novo Nordisk at 1-888-668-6444 for help.

Figure H

Drop of Norditropin - Illustration

Step 3. Select your dose

To start, check that the dose counter is set at 0.

Turn the dose selector clockwise to select the dose you need. See figure I.

When you have selected your dose, you can proceed to step 4.

If there is not enough Norditropin left to select a full dose, see Frequently Asked Questions.

Figure I

Turn the dose selector clockwise - Illustration

The dose counter shows the dose in mg. See figures J and K. Always use the dose counter to select the exact dose. Do not count the Pen clicks. Do not use the Pen scale.

Figure J AND K

The dose counter - Illustration

If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.

The Pen clicks sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you accidentally force it past the number of mg left.

Figure L

Correcting the dose - Illustration

Step 4. Inject your dose

Norditropin can be injected under the skin (subcutaneously) of your hips, stomach area (abdomen), buttocks, upper legs (thighs), upper arms, or as otherwise instructed by your healthcare provider. Change the injection site every day.

Insert the needle into your skin as your healthcare provider has shown you. See figure M.

Make sure you can see the dose counter. Do not cover it with your fingers. This could block the injection.

Figure M

Insert the needle into your skin - Illustration

Press and hold down the dose button until the dose counter shows 0. See figure N. The 0 must line up with the dose pointer. You may then hear or feel a click.

Continue to hold the needle in your skin.

If 0 does not appear in the dose counter after continuously pressing the dose button, your needle may be blocked or damaged, see Frequently Asked Questions.

Figure N

Press and hold down the dose button - Illustration

Keep the needle in your skin after the dose counter has returned to 0. Count slowly to 6 to ensure that the full dose has been delivered. See figure O.

Figure O

Count slowly to 6 - Illustration

Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly. Do not rub the area.

You may see a drop of Norditropin at the needle tip after injecting. This is normal and does not affect your dose.

Figure P

Carefully remove the needle - Illustration

Step 5. After your injection

Carefully remove the needle from the Pen by turning counterclockwise. See figure Q.

Figure Q

Remove the needle from the Pen - Illustration

Place the needle in a sharps container immediately to reduce the risk of needle sticks. See figure R.

Figure R

Place the needle in a sharps container - Illustration

Do not try to put the needle caps back on. You may stick yourself with the needle.

Put the Pen cap on your Pen after each use to protect the Norditropin from direct light. See figure S.

To store your Pen, see the Patient Information section.

Figure S

Put the Pen cap on - Illustration

Always dispose of the needle after each injection. Put the needle and any empty or discarded Pen still containing Norditropin in an FDA-cleared sharps disposal container. See figure T.

For further information about safe sharps disposal, see Frequently Asked Questions.

Figure T

Dispose of the needle - Illustration

Always remove the needle from your Pen. This reduces the risk of contamination, infection, leakage of Norditropin, and blocked needles leading to incorrect dosing.

Frequently Asked Questions

How do I see how much Norditropin is left in my Pen?

The Pen scale shows you approximately how much Norditropin is left in your Pen. See figure U below.

Figure U

Dose remaining - Illustration

To see how much Norditropin is left, use the dose counter: Turn the dose selector clockwise until the dose counter stops. You can select a maximum dose of 8.0 mg. If it shows 8.0 mg, at least 8.0 mg are left in your Pen. If it shows 3.8, only 3.8 mg are left in your Pen. See figure V below.

Figure V

Dose remaining - Illustration

What if I need a larger dose than what is left in my Pen?

It is not possible to select a larger dose than the amount of mg left in your Pen.

If you need more Norditropin than you have left in your Pen, you can use a new Pen or split your dose between your current Pen and a new Pen. Only if trained or advised by your healthcare provider, may you split your dose. Use a calculator to plan the doses as instructed by your healthcare provider.

Be very careful to calculate correctly. If you are not sure how to split your dose using two Pens, then select and inject the dose you need with a new Pen.

What if no Norditropin appears when I check the flow?

A. Your needle may be blocked or damaged, if no Norditropin appears at the needle tip. Remove the needle as described in step 5 and repeat steps 1 and 2.

B. Your Pen may be defective, if Norditropin still does not appear after changing the needle. Do not use the Pen. Contact Novo Nordisk at 1-888-668-6444.

What if 0 does not appear after completing my injection?

In this case the needle may be blocked or damaged, and you have not received any Norditropin – even though the dose counter has moved from the original dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.

How should I take care of my Pen?

Be careful not to drop your Pen or knock it against hard surfaces. Do not expose your Pen to dust, dirt, liquid, or direct light.

If there is Norditropin left in the Pen, store the Pen as directed in the Patient Information section How do I store Norditropin.

Do not try to refill your Pen, it's prefilled.

Frequently Asked Questions

What if I drop my Pen?

If you drop your Pen or think that something is wrong with it, attach a new disposable needle and check the Norditropin flow before you inject, see steps 1 and 2. Do not try to repair your Pen or pull it apart.

How do I clean my Pen?

Do not wash, soak, or lubricate your Pen. If necessary, clean it with mild detergent on a moistened cloth.

How do I dispose of needles and Pens?

Empty Pens should be disposed of as directed below. Put your used needles and Pen in an FDA-cleared sharps disposal container right away after use. Do not dispose of loose needles and Pens in your household trash. If you do not have an 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.

Follow your community guidelines on how to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and Pens. For specific information about safe 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.

Important information

Caregivers must be very careful when handling needles – to reduce the risk of needle sticks and cross-infection.

Always keep your Pen and needles out of reach of others, especially children.

Norditropin® FlexPro® 30 mg/3 mL Pen is not compatible with FlexPro® PenMate®.

To store your Pen, see How do I store Norditropin in the Patient Information.

Patient Information

QR Code for Patient Information - Illustration

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 2/26/2015
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

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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