July 31, 2015

Norditropin




PATIENT INFORMATION

INSTRUCTIONS FOR USE

Norditropin®
(Nor-dee-tro-pin)

FlexPro®
(somatropin [rDNA origin] injection) Prefilled Pen with PenMate®

Read this Instructions for Use before you start using your Pen with PenMate.

  • PenMate hides the needle when you inject your Norditropin growth hormone with Norditropin FlexPro 5 mg, 10 mg, and 15 mg Pens so that you cannot see it. Use your PenMate only after you have been trained by a healthcare provider.
  • Blind people or people with severe vision problems should only use the PenMate and Pen with help from another person with good eyesight who is trained to use the PenMate and Pen.
  • The figures in these instructions show PenMate being used with a Norditropin FlexPro 5 mg Pen and a NovoFine needle that is 8 mm long. Even if you are using a 10 mg or 15 mg Pen or a different needle that is 8 mm long the instructions are the same.
  • Do not share your Norditropin Pen and needles with another person. You may give another person an infection or get an infection from them.

Supplies you will need to use your Pen with PenMate:

  • 1 PenMate. See figure A.
  • 1 Norditropin FlexPro Pen. See figure B. PenMate does not work with other injection devices.
  • 1 disposable needle up to a length of 8 mm. See figure C. Needles are not included with your PenMate or Pen.
  • 2 alcohol swabs. See figure C.
  • a sharps disposal container. See figure C. See ”How should I dispose of my Pen and needles” at the end of these instructions for information on how to dispose of used needles.

PenMate: Figure A

PenMate - Illustration

Norditropin FlexPro 5 mg, 10 mg or 15 mg Pen: Figure B

Norditropin FlexPro 5 mg, 10 mg or 15 mg Pen - Illustration

Needle parts: Figure C

Needle parts - Illustration

Pen case: Figure D

Pen case - Illustration

Step 1: Preparing your Pen with PenMate:

Wash your hands with soap and water and dry them. Check the name and the colored label on your Pen to make sure it contains the growth hormone strength prescribed by your healthcare provider.

Pull off the PenMate cap.

See figure E.

Figure E

Pull off the PenMate cap - Illustration

Pull off the Pen cap and throw it away.

See figure F.

You will not need the Pen cap with your PenMate.

Figure F

Pull off the Pen cap and throw it away - Illustration

Look in the Pen window. Check that the liquid medicine in your Pen is clear and colorless by tipping it upside down 1 or 2 times.

See figure G. If the liquid looks cloudy or unclear, do not use the Pen.

Figure G

Pen window - Illustration

Wipe the front stopper on the needle thread of the Pen with an alcohol swab. See figure H.

Figure H

Wipe the front stopper - Illustration

Insert the Pen into the PenMate. Twist the Pen clockwise until you hear or feel a click. See figure I.

The Pen is correctly attached in your PenMate when the display window on the Pen lines up with the insertion button on your PenMate.

Figure I

Insert the Pen into the PenMate - Illustration

Step 2. Attaching the needle to your Pen:

  • Do not place a needle on your Pen until you are ready to give an injection.
  • Always use a new needle for each injection.
  • Do not use a bent or damaged needle.

Take a new disposable needle and tear off the paper tab. See figure J.

Figure J

Tear off the paper tab - Illustration

Holding the Pen with 1 hand, firmly press the needle onto the needle thread of the Pen. Screw the needle in a clockwise direction until the needle will not turn anymore. See figure K.

Figure K

Screw the needle in clockwise - Illustration

Pull off the outer needle cap and save it. See figure L.

You will need the outer needle cap after the injection so you can safely remove the needle from the Pen.

Figure L

Pull off the outer needle cap - Illustration

Pull off the inner needle cap and throw it away. See figure M.

A drop of liquid may appear at the needle tip. This is normal.

Figure M

Inner needle cap - Illustration

Step 3. Priming a new Pen:

Checking the growth hormone flow in the Pen (priming) is not needed for a Pen you have used before. If the Pen has already been primed, go to Step 4.

Before you use a new Pen you must prepare it for use. Hold the Pen with 1 hand and turn the dose selector clockwise 1 tick mark to select the minimum dose. See figure N.

You may hear or feel a click when you turn the dose selector.

Figure N

Dose selector - Illustration

When you turn the dose selector 1 tick mark, you select the smallest amount of medicine for a dose. See figure O.

Figure O

Dose code - Illustration

This lowest dose will be used for your Norditropin flow check dose.

Hold your Pen with PenMate with the needle pointing up. You may see air bubbles in the PenMate window. Gently tap the top of PenMate a few times to let any air bubbles rise to the top. See figure P.

Figure P

Gently tap the top of PenMate - Illustration

Press the dose button until the dose pointer lines up with the “0” in the display window on the Pen and a drop of liquid appears at the needle tip. See figure Q.

Figure Q

Press the dose button - Illustration

If no drop of liquid appears at the needle tip, repeat Step 3 again up to 6 times.

If there is still no drop of liquid at the needle tip, change the needle and repeat Step 3 again.

If a drop of liquid still does not appear at the needle tip after repeating Step 3 and changing the needle, call Novo Nordisk at 1-888-668-6444 for assistance.

Step 4. Selecting the correct dose of Norditropin:

Use the dose selector on your Pen to make sure you have the exact dose selected. Your dose will be in a certain number of mg (milligrams).

To start, check that the dose pointer on the Pen is set at “0”.

Select the dose you need by turning the dose selector clockwise. If you go beyond your dose, turn the dose selector counterclockwise until the right number of mg lines up with the dose pointer. See figure R.

Figure R

Select the dose you need - Illustration

To guide you, the dose selector click sound is different when turned clockwise (softer click) or counterclockwise (louder click). You will hear a click for every single unit dialed.

When dialing counterclockwise, be careful not to press the dose button as liquid will come out.

You can use the growth hormone scale on the side of the Pen to see approximately how much growth hormone is left in the Pen. You can also use the dose selector to see exactly how much growth hormone is left in the Pen.

If the Pen contains less than 2 mg, 4 mg, or 8 mg (depending on whether you use a 5 mg, 10 mg, or 15 mg Pen), turn the dose selector until it stops. The number that lines up with the dose pointer shows how many mg are left in the Pen. You cannot set a dose higher than the number of mg left in the Pen.

If there is not enough Norditropin left in the Pen for your full dose, use a new Norditropin FlexPro Pen to inject the remaining amount of your dose or contact your healthcare provider.

Remember to subtract the dose already received. For example, if the dose is 0.7 mg and you can only set the dose selector to 0.35 mg, you should inject another 0.35 mg with a new Norditropin FlexPro Pen.

Important:

Do not use the Pen clicks to count the number of mg you select. Only the display window and dose pointer will show the exact number.

Do not use the growth hormone scale to measure how much liquid to inject. Only the display window and dose pointer will show the exact number.

Step 5. Selecting your injection site and injecting the dose of Norditropin:

Change your injection site every day. Select the injection site and wipe your skin with an alcohol swab as your healthcare provider showed you.

Norditropin can be injected under your skin (subcutaneously) of your hips, stomach area (abdomen), upper legs (thighs), upper arms, or as otherwise instructed by your healthcare provider. See Figure S.

Figure S

Selecting your injection site - Illustration

Hold onto both the PenMate and your Pen without touching the insertion button on the PenMate or the dose button on the Pen.

Do not press the insertion button on the PenMate before you are ready to inject your dose. This lowers the risk of hurting yourself with the needle.

Hold the PenMate firmly with 1 hand and pull the Pen out with your other hand until you hear and feel a click. See figure T.

The needle is now hidden in PenMate.

Figure T

Insertion button on PenMate - Illustration

Norditropin is for use under your skin only (subcutaneous). Hold the PenMate against your skin. Press the insertion button on the PenMate until you hear or feel a click. When you hear or feel the click, the needle has been inserted automatically into your skin. See figure U.

You are now ready to inject your dose.

Figure U

Press the insertion button on the PenMate - Illustration

Press the dose button on the Pen to inject your dose. Do not turn the dose button while you are pressing it. If you turn the dose button, you will not inject growth hormone.

Make sure you can see the display window. Do not cover it with your fingers. Press and hold down the dose button on the Pen until the display window returns to “0”.

The “0” must line up with the dose pointer. You may then hear or feel a firm click. See figure V.

Figure V

Press and hold down the dose button - Illustration

If the dose button cannot be pushed in completely or “0” does not appear in the display window, you did not receive the full dose. Call Novo Nordisk at 1-888-668-6444 for assistance. You may need a new Pen.

After the display window has returned to “0”, leave the needle under your skin for at least 6 seconds to make sure you get your full dose. See figure V.

Let go of the dose button while you wait.

Important: Always press the dose button to inject the dose. Turning the dose selector will not inject the dose.

Do not touch the display window when you inject, as this can block the injection.

Carefully lift the Pen to remove the needle from the skin. See figure W.

Figure W

Carefully lift the Pen to remove the needle from the skin - Illustration

Step 6. What to do after your injection is completed:

Carefully put the outer needle cap back on the needle. Remove the needle from the Pen after each injection. See figure X.

Figure X

Put the outer needle cap back - Illustration

Unscrew the needle by turning it counterclockwise. Do not touch the needle. Hold the Pen with 1 hand and carefully remove the needle from the Pen with your other hand. See figure Y.

Dispose of the needle as directed by a healthcare provider. See “How should I dispose of my Pen and needles?” at the end of these instructions.

Figure Y

Unscrew the needle - Illustration

Put the PenMate cap back on your PenMate after each use to protect the growth hormone from light. See figure Z.

Figure Z

Put the PenMate cap back on - Illustration

Important safety information to remember:

  • Be careful not to drop your PenMate and Pen or knock them against a hard surface. If this happens you will need to check the growth hormone flow.
  • Do not try to put the inner needle cap back on the needle. You may stick yourself with the needle. Be careful when handling used needles to avoid needle stick injuries.
  • After each use always remove and dispose of the needle from your Pen.
  • Do not share your Pen or needles with other people.
  • If your PenMate is damaged or lost, you can still use your Pen without your PenMate.
  • Always keep your Pen and needles out of reach of others, especially children.

How should I replace an empty Pen?

PenMate is reusable and should not be disposed of. Reuse your PenMate by replacing your Pen when it is empty.

When your Pen is empty, twist the Pen until you hear or feel a click. See figure AA.

Figure AA

Twist the Pen - Illustration

Gently pull the Pen out of PenMate.

See figure BB.

Before disposing of your empty Pen, make sure the needle has been removed. Dispose of the empty Pen as recommended by your healthcare provider. See “How should I dispose of my Pen and needles?” at the end of these instructions.

Figure BB

Gently pull the Pen out of PenMate - Illustration

Insert the new Pen into your PenMate. See figure CC.

Figure CC

Insert the new Pen into your PenMate - Illustration

Twist the Pen until you hear or feel a click. See figure DD.

The Pen is correctly attached in your PenMate when the display window on the Pen lines up with the insertion button on your PenMate.

Figure DD

Twist the Pen - Illustration

How should I store my PenMate and Pen?

  • Do not expose your PenMate or Pen to dust, dirt, or any kind of liquid.
  • Store your PenMate and Pen in their case. See figure D at the beginning of these instructions.
  • When your Pen is inserted in PenMate, store it as described in the Patient Information Leaflet that comes with your Pen.

How should I care for and clean my Pen with PenMate?

  • Do not try to refill your Pen. It is prefilled.
  • Do not try to repair your PenMate or your Pen.
  • Only clean your PenMate or Pen with a mild detergent on a moistened cloth.
  • Do not wash, soak, or lubricate your PenMate or Pen. Do not use products containing bleaching agents, such as chlorine, iodine, or alcohol to clean your PenMate or Pen. These products may damage them.
  • If there is liquid growth hormone on the outside of your PenMate or Pen, clean it with a mild detergent on a moistened cloth before it dries up.

How should I dispose of my Pen and needles?

  • Put your used needles and Pens 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:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and Pens. 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: 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.

Need help?

PenMate must only be used according to the instructions provided. The manufacturer cannot be held responsible for any problems with PenMate if these instructions have not been followed.

If you find that your PenMate or case is defective, make sure to have Novo Nordisk replace it. Call the number below to order a new PenMate or case and arrange return of the defective item for inspection.

For assistance or further information, write to:
Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536

Last reviewed on RxList: 7/8/2015
This monograph has been modified to include the generic and brand name in many instances.

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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