Norditropin

PATIENT INFORMATION

Norditropin®
(Nor-dee-tro-pin) Cartridges
(somatropin [rDNA origin]) Injection for Subcutaneous Use

What is Norditropin?

Norditropin is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body.

Norditropin is given by injection under the skin (subcutaneous) and is used to treat:

  • children who are not growing because of low or no growth hormone
  • children who are short (in stature) and who have Noonan syndrome or Turner syndrome
  • children who are short (in stature) because they were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years
  • adults who did not make enough growth hormone when they were children or when they became adults

Who should not use Norditropin?

Do not use Norditropin if:

  • you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems
  • you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea
  • you have cancer or other tumors
  • your healthcare provider tells you that you have certain types of eye problems caused by diabetes
  • you are a child with closed bone growth plates (epiphyses)
  • you are allergic to somatropin or any of the ingredients in Norditropin. See the end of this leaflet for a complete list of ingredients in Norditropin.

What should I tell my healthcare provider before I start Norditropin?

Before you take Norditropin, tell your healthcare provider if you:

  • have diabetes
  • had cancer or any tumor
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if Norditropin will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Norditropin passes into your breast milk. You and your healthcare provider should decide if you will take Norditropin while you breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Norditropin may affect how other medicines work, and other medicines may affect how Norditropin works.

How should I use Norditropin?

  • Read the detailed Instructions for Use that come with Norditropin.
  • Norditropin comes in 4 different dosage strengths. Your healthcare provider will prescribe the dose that is right for you.
  • Your healthcare provider will show you how to inject Norditropin.
  • Use Norditropin exactly as your healthcare provider tells you to.
  • Norditropin FlexPro pens and Norditropin NordiFlex pen are for use for 1 person only.
  • Do not share your Norditropin pen and needles with another person. You may give another person an infection or get an infection from them.

What are the possible side effects of Norditropin?

Norditropin can cause serious side effects, including:

  • high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems
  • high risk of death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
  • return of tumor or cancerous growths
  • high blood sugar (hyperglycemia)
  • increase in pressure in the skull (intracranial hypertension). If you have headaches, eye problems, nausea or vomiting, swollen hands and feet due to fluid retention contact your healthcare provider right away
  • decrease in thyroid hormone levels. Your healthcare provider will do blood tests to check your thyroid hormone levels.
  • hip and knee pain or a limp in children (slipped capital femoral epiphysis)
  • worsening of curvature of the spine (scoliosis)
  • middle ear infection, hearing problems or ear problems in people with Turner syndrome, redness, itching and tissue weakness in the area of skin you inject
  • increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your healthcare provider will do blood tests to check this.

The most common side effects of Norditropin include:

  • headaches
  • muscle pain
  • joint stiffness
  • high blood sugar (hyperglycemia)
  • sugar in your urine (glucosuria)

These are not all the possible side effects of Norditropin.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store Norditropin?

New or unused Norditropin FlexPro pens and Norditropin NordiFlex pen:

  • Keep Norditropin in a refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze or expose Norditropin to heat.
  • Keep Norditropin away from direct light.
  • Do not use Norditropin that has been frozen or in temperatures warmer than 77°F (25°C).
  • Do not use Norditropin after the expiration date printed on the carton and the pen.

Used Norditropin FlexPro pens and Norditropin NordiFlex pen:

After the first injection of Norditropin,

either

  • store remaining Norditropin in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 4 weeks

or

  • store remaining Norditropin at room temperature no warmer than 77°F (25°C) and use within 3 weeks

Keep Norditropin and all medicines out of the reach of children.

General Information about the safe and effective use of Norditropin.

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

What are the ingredients in Norditropin?

Active ingredient: somatropin (rDNA origin)

Inactive ingredients: Histidine, Poloxamer 188, Phenol, Mannitol, HCl/NaOH (as needed) and Water for Injection

INSTRUCTIONS FOR USE

Norditropin®
(Nor-dee-tro-pin) FlexPro® (somatropin [rDNA origin] injection) 5 mg/1.5 mL Pen

Note:

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.

Norditropin® FlexPro®

Figure A

Norditropin® FlexPro - Illustration

Supplies you will need for a Norditropin Injection. See Figure A.

  • Norditropin FlexPro Prefilled Pen
  • 1 Novo Nordisk disposable needle. Needles are not included with the Pen.
  • 2 alcohol swabs
  • flat surface like a table
  • a sharps disposal container. See Step 6 for information on how to dispose of used needles and syringes.

6 Steps you should follow for a Norditropin injection:

Step 1. Preparing the Norditropin FlexPro Pen

Step 2. Attaching the needle to the Norditropin FlexPro Pen

Step 3. Priming a new Pen Step 4. Selecting the correct dose of Norditropin

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

Step 6. What to do after the injection is completed.

Step 1. Preparing the Norditropin FlexPro Pen.

  • Pull off the Pen cap. See Figure B.

Figure B

Pull off the Pen cap - Illustration

  • Look in the growth hormone scale window. Check that the liquid medicine in the Pen is clear and colorless by tipping it upside down 1 or 2 times. If the liquid looks unclear or cloudy, do not use the Pen. See Figure C.

Figure C

Growth hormone scale window - Illustration

  • Wash your hands well and dry them.
  • Wipe the front stopper on the needle thread with an alcohol swab. See Figure D.

Figure D

Wipe the front stopper - Illustration

Step 2. Attaching the needle to the Norditropin FlexPro Pen.

  • Never place a needle on your Pen until you are ready to give an injection.
  • Take a new disposable needle and tear off the paper tab. See Figure E.

Figure E

Attaching the needle - Illustration

  • Holding the Pen with one 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 F.

Figure F

Screw the needle in - Illustration

  • Pull off the outer needle cap. See Figure G.

Figure G

Pull off the outer needle cap - Illustration

  • Pull off the inner needle cap and throw them both away. See Figure H. If you try to put the needle caps back on, you may accidentally hurt yourself with the needle.
  • A drop of liquid may appear at the needle tip. This is normal.

Figure H

Pull off the 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 first prepare it for use. Hold the Pen with one hand and turn the dose selector clockwise to select 0.025 mg. You will hear a faint click when you turn the dose selector. This is the smallest amount of medicine for a dose. See Figure I.

Figure I

The dose selector - Illustration

  • 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 J.

Figure J

Tap the top of the Pen gently - Illustration

  • Press the dose button until the “0” in the display window lines up with the pointer and a drop of liquid appears at the needle tip. See Figure K.

Figure K

Press the dose button - Illustration

  • If no drop appears, repeat Step 3 again up to 6 times.
  • If you still do not see a drop of liquid, change the needle and repeat Step 3 again.
  • If a drop of liquid still does not appear after repeating Step 3 and changing the needle, call Novo Nordisk at 1-888-668-6444 for help.

Step 4. Selecting the correct dose of Norditropin.

  • Use the dose selector on your Norditropin FlexPro Pen to make sure you have the exact dose selected. You can select up to 2 mg per dose.
  • To start, check that the pointer on the Pen is set at “0”. See Figure L.

Figure L

Check the pointer - Illustration

  • 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 pointer.
  • 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, turn the dose selector until it stops. The number that lines up with the pointer shows how many mg is 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 to deliver 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. See Figure L.

Important:

  • Never use the Pen clicks to count the number of mg you select. Only the display window and pointer will show the exact number.
  • Never use the growth hormone scale to measure how much liquid to inject. Only the display window and pointer will show the exact number.

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

  • Change the injection site every day.
  • Select the injection site and wipe the skin with an alcohol swab as your healthcare provider showed you.
  • Insert the needle under the skin as your healthcare provider showed you. See Figure M.

Figure M

Insert the needle under the skin - Illustration

  • After inserting the needle into the skin, push and hold the dose button in as far as it will go to give the dose. Inject until the “0” in the display window lines up with the pointer. As you do this, you may hear or feel a firm click. See Figure M.
  • If you remove your finger from the dose button before the “0” is in the display window the full dose has not been received. Leave the needle in the skin and press and hold the dose button again until the “0” lines up with the pointer.

If the injection 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 “0” in the display window lines up with the pointer, leave the needle under the skin for at least 6 seconds to make sure that you get your full dose. 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.
  • Never touch the display window when you inject, as this can block the injection.
  • Carefully lift the pen to remove the needle from the skin. After that, you may see a drop of liquid at the needle tip. This is normal and does not affect the dose you received. See Figure N.

Figure N

Carefully lift the pen  - Illustration

Step 6. What to do after the injection is completed.

  • Do not recap the needle. Recapping a needle can lead to a needle stick injury. Remove the needle from the Pen after each injection.
  • Carefully remove the needle from the Pen by turning the needle in a counterclockwise direction. See Figure O.

Figure O

Carefully remove the needle - Illustration

  • Put the Pen cap back on.
  • If there is medicine left in the Pen, store the Pen as directed in the Patient Information that comes with this Pen.
  • If the Pen is empty, throw the Pen away as directed below. Put your used needles and Pen 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: 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.

Care of your Norditropin FlexPro Pen:

You must take care of your Norditropin FlexPro Pen:

  • Do not drop your Pen or knock it against hard surfaces. If you drop it or think that something is wrong with it, always screw on a new disposable needle and check the growth hormone flow (priming) before you inject.
  • Do not try to refill your Pen. It is prefilled.
  • Do not try to repair your Pen or pull it apart.
  • Do not expose your Pen to dust, dirt or any kind of liquid.
  • Do not try to wash, soak or lubricate your Pen. Clean the Norditropin FlexPro Pen with a mild detergent on a moistened cloth.
  • Always keep your Pen and needles out of reach of others, especially children.

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

Norditropin® Cartridges [somatropin (rDNA origin) injection] Figure  Illustration

INSTRUCTIONS FOR USE

Norditropin®
(Nor-dee-tro-pin) FlexPro® (somatropin [rDNA origin] injection) 10 mg/1.5 mL Pen

Note:

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.

Norditropin® FlexPro®

Figure A

Norditropin® FlexPro® Supplies needed - Illustration

Supplies you will need for a Norditropin Injection. See Figure A.

  • Norditropin FlexPro Prefilled Pen
  • 1 Novo Nordisk disposable needle. Needles are not included with the Pen.
  • 2 alcohol swabs
  • flat surface like a table
  • a sharps disposal container. See Step 6 for information on how to dispose of used needles and syringes.

6 Steps you should follow for a Norditropin injection:

Step 1. Preparing the Norditropin FlexPro Pen

Step 2. Attaching the needle to the Norditropin FlexPro Pen

Step 3. Priming a new Pen

Step 4. Selecting the correct dose of Norditropin

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

Step 6. What to do after the injection is completed.

Step 1. Preparing the Norditropin FlexPro Pen.

  • Pull off the Pen cap. See Figure B.

Figure B

Pull off the Pen cap - Illustration

  • Look in the growth hormone scale window. Check that the liquid medicine in the Pen is clear and colorless by tipping it upside down 1 or 2 times. If the liquid looks unclear or cloudy, do not use the Pen. See Figure C.

Figure C

Growth hormone scale window - Illustration

  • Wash your hands well and dry them.
  • Wipe the front stopper on the needle thread with an alcohol swab. See Figure D.

Figure D

Wipe the front stopper - Illustration

Step 2. Attaching the needle to the Norditropin FlexPro Pen.

  • Never place a needle on your Pen until you are ready to give an injection.
  • Take a new disposable needle and tear off the paper tab. See Figure E.

Figure E

Tear off the paper tab - Illustration

  • Holding the Pen with one 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 F.

Figure F

Screw the needle in - Illustration

  • Pull off the outer needle cap. See Figure G.

Figure G

Pull off the outer needle cap - Illustration

  • Pull off the inner needle cap and throw them both away. See Figure H. If you try to put the needle caps back on, you may accidentally hurt yourself with the needle.
  • A drop of liquid may appear at the needle tip. This is normal.

Figure H

A drop of liquid may appear at the needle tip - 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 first prepare it for use. Hold the Pen with one hand and turn the dose selector clockwise to select 0.05 mg. You will hear a faint click when you turn the dose selector. This is the smallest amount of medicine for a dose. See Figure I.

Figure I

Turn the dose selector - Illustration

  • 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 J.

Figure J

Tap the top of the Pen gently - Illustration

  • Press the dose button until the “0” in the display window lines up with the pointer and a drop of liquid appears at the needle tip. See Figure K.

Figure K

Press the dose button - Illustration

  • If no drop appears, repeat Step 3 again up to 6 times.
  • If you still do not see a drop of liquid, change the needle and repeat Step 3 again.
  • If a drop of liquid still does not appear after repeating Step 3 and changing the needle, call Novo Nordisk at 1-888-668-6444 for help.

Step 4. Selecting the correct dose of Norditropin.

  • Use the dose selector on your Norditropin FlexPro Pen to make sure you have the exact dose selected. You can select up to 4 mg per dose.
  • To start, check that the pointer on the Pen is set at “0”. See Figure L.

Figure L

Pointer on the Pen is set at “0” -  Illustration

  • 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 pointer.
  • 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 4 mg, turn the dose selector until it stops. The number that lines up with the pointer shows how many mg is 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 to deliver 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 1.4 mg and you can only set the dose selector to 0.7 mg, you should inject another 0.7 mg with a new Norditropin FlexPro Pen. See Figure L.

Important:

  • Never use the Pen clicks to count the number of mg you select. Only the display window and pointer will show the exact number.
  • Never use the growth hormone scale to measure how much liquid to inject. Only the display window and pointer will show the exact number.

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

  • Change the injection site every day.
  • Select the injection site and wipe the skin with an alcohol swab as your healthcare provider showed you.
  • Insert the needle under the skin as your healthcare provider showed you. See Figure M.

Figure M

Insert the needle - Illustration

  • After inserting the needle into the skin, push and hold the dose button in as far as it will go to give the dose. Inject until the “0” in the display window lines up with the pointer. As you do this, you may hear or feel a firm click. See Figure M.
  • If you remove your finger from the dose button before the “0” is in the display window the full dose has not been received. Leave the needle in the skin and press and hold the dose button again until the “0” lines up with the pointer.

If the injection 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 “0” in the display window lines up with the pointer, leave the needle under the skin for at least 6 seconds to make sure that you get your full dose. 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.
  • Never touch the display window when you inject, as this can block the injection.
  • Carefully lift the pen to remove the needle from the skin. After that, you may see a drop of liquid at the needle tip. This is normal and does not affect the dose you received. See Figure N.

Figure N

Carefully lift the pen - Illustration

Step 6. What to do after the injection is completed.

  • Do not recap the needle. Recapping a needle can lead to a needle stick injury. Remove the needle from the Pen after each injection.
  • Carefully remove the needle from the Pen by turning the needle in a counterclockwise direction. See Figure O.

Figure O

Carefully remove the needle - Illustration

  • Put the Pen cap back on.
  • If there is medicine left in the Pen, store the Pen as directed in the Patient Information that comes with this Pen.
  • If the Pen is empty, throw the Pen away as directed below. Put your used needles and Pen 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: 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.

Care of your Norditropin FlexPro Pen:

You must take care of your Norditropin FlexPro Pen:

  • Do not drop your Pen or knock it against hard surfaces. If you drop it or think that something is wrong with it, always screw on a new disposable needle and check the growth hormone flow (priming) before you inject.
  • Do not try to refill your Pen. It is prefilled.
  • Do not try to repair your Pen or pull it apart.
  • Do not expose your Pen to dust, dirt or any kind of liquid.
  • Do not try to wash, soak or lubricate your Pen. Clean the Norditropin FlexPro Pen with a mild detergent on a moistened cloth.
  • Always keep your Pen and needles out of reach of others, especially children.

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

Norditropin® Cartridges [somatropin (rDNA origin) injection] Figure  Illustration

INSTRUCTIONS FOR USE

Norditropin®
(Nor-dee-tro-pin) FlexPro® (somatropin [rDNA origin] injection) 15 mg/1.5 mL Pen

Note:

  • 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.

Norditropin® FlexPro®

Figure A

Supplies needed - Illustration

Supplies you will need for a Norditropin Injection. See Figure A.

  • Norditropin FlexPro Prefilled Pen
  • 1 Novo Nordisk disposable needle. Needles are not included with the Pen.
  • 2 alcohol swabs
  • flat surface like a table
  • a sharps disposal container. See Step 6 for information on how to dispose of used needles and syringes.

6 Steps you should follow for a Norditropin injection:

Step 1. Preparing the Norditropin FlexPro Pen

Step 2. Attaching the needle to the Norditropin FlexPro Pen

Step 3. Priming a new Pen

Step 4. Selecting the correct dose of Norditropin

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

Step 6. What to do after the injection is completed.

Step 1. Preparing the Norditropin FlexPro Pen.

  • Pull off the Pen cap. See Figure B.

Figure B

Pull off the Pen cap - Illustration

  • Look in the growth hormone scale window. Check that the liquid medicine in the Pen is clear and colorless by tipping it upside down 1 or 2 times. If the liquid looks unclear or cloudy, do not use the Pen. See Figure C.

Figure C

Growth hormone scale window - Illustration

  • Wash your hands well and dry them.
  • Wipe the front stopper on the needle thread with an alcohol swab. See Figure D.

Figure D

Wipe the front stopper - Illustration

Step 2. Attaching the needle to the Norditropin FlexPro Pen.

  • Never place a needle on your Pen until you are ready to give an injection.
  • Take a new disposable needle and tear off the paper tab. See Figure E.

Figure E

Tear off the paper tab - Illustration

  • Holding the Pen with one 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 F.

Figure F

Screw the needle in - Illustration

  • Pull off the outer needle cap. See Figure G.

Figure G

Pull off the outer needle cap - Illustration

  • Pull off the inner needle cap and throw them both away. See Figure H.
  • If you try to put the needle caps back on, you may accidentally hurt yourself with the needle.
  • A drop of liquid may appear at the needle tip. This is normal.

Figure H

A drop of liquid may appear - 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 first prepare it for use. Hold the Pen with one hand and turn the dose selector clockwise to select 0.1 mg. You will hear a faint click when you turn the dose selector. This is the smallest amount of medicine for a dose. See Figure I.

Figure I

Turn the dose selector - Illustration

  • 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 J.

Figure J

Tap the top of the Pen gently - Illustration

  • Press the dose button until the “0” in the display window lines up with the pointer and a drop of liquid appears at the needle tip. See Figure K.

Figure K

Press the dose button - Illustration

  • If no drop appears, repeat Step 3 again up to 6 times.
  • If you still do not see a drop of liquid, change the needle and repeat Step 3 again.
  • If a drop of liquid still does not appear after repeating Step 3 and changing the needle, call Novo Nordisk at 1-888-668-6444 for help.

Step 4. Selecting the correct dose of Norditropin.

  • Use the dose selector on your Norditropin FlexPro Pen to make sure you have the exact dose selected. You can select up to 8 mg per dose.
  • To start, check that the pointer on the Pen is set at “0”. See Figure L.

Figure L

Select exact dose - Illustration

  • 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 pointer.
  • 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 8 mg, turn the dose selector until it stops. The number that lines up with the pointer shows how many mg is 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 to deliver 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 0.6 mg and you can only set the dose selector to 0.3 mg, you should inject another 0.3 mg with a new Norditropin FlexPro Pen. See Figure L.

Important:

  • Never use the Pen clicks to count the number of mg you select. Only the display window and pointer will show the exact number.
  • Never use the growth hormone scale to measure how much liquid to inject. Only the display window and pointer will show the exact number.

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

  • Change the injection site every day.
  • Select the injection site and wipe the skin with an alcohol swab as your healthcare provider showed you.
  • Insert the needle under the skin as your healthcare provider showed you. See Figure M.

Figure M

Insert the needle - Illustration

  • After inserting the needle into the skin, push and hold the dose button in as far as it will go to give the dose. Inject until the “0” in the display window lines up with the pointer. As you do this, you may hear or feel a firm click. See Figure M.
  • If you remove your finger from the dose button before the “0” is in the display window the full dose has not been received. Leave the needle in the skin and press and hold the dose button again until the “0” lines up with the pointer.

If the injection 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 “0” in the display window lines up with the pointer, leave the needle under the skin for at least 6 seconds to make sure that you get your full dose. 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.
  • Never touch the display window when you inject, as this can block the injection.
  • Carefully lift the pen to remove the needle from the skin. After that, you may see a drop of liquid at the needle tip. This is normal and does not affect the dose you received. See Figure N.

Figure N

Carefully lift the pen - Illustration

Step 6. What to do after the injection is completed.

  • Do not recap the needle. Recapping a needle can lead to a needle stick injury. Remove the needle from the Pen after each injection.
  • Carefully remove the needle from the Pen by turning the needle in a counterclockwise direction. See Figure O.

Figure O

Carefully remove the needle - Illustration

  • Put the Pen cap back on.
  • If there is medicine left in the Pen, store the Pen as directed in the Patient Information that comes with this Pen.
  • If the Pen is empty, throw the Pen away as directed below. Put your used needles and Pen 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: 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.

Care of your Norditropin FlexPro Pen:

You must take care of your Norditropin FlexPro Pen:

  • Do not drop your Pen or knock it against hard surfaces. If you drop it or think that something is wrong with it, always screw on a new disposable needle and check the growth hormone flow (priming) before you inject.
  • Do not try to refill your Pen. It is prefilled.
  • Do not try to repair your Pen or pull it apart.
  • Do not expose your Pen to dust, dirt or any kind of liquid.
  • Do not try to wash, soak or lubricate your Pen. Clean the Norditropin FlexPro Pen with a mild detergent on a moistened cloth.
  • Always keep your Pen and needles out of reach of others, especially children.

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

Norditropin® Cartridges [somatropin (rDNA origin) injection] Figure  Illustration

INSTRUCTIONS FOR USE

Norditropin®
(Nor-dee-tro-pin) NordiFlex® (somatropin [rDNA origin] injection) 30 mg/3 mL Pen

Note:

  • 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.

Norditropin® NordiFlex®

Figure A

Supplies needed - Illustration

Supplies you will need for a Norditropin Injection. See Figure A.

  • Norditropin NordiFlex Prefilled Pen
  • 1 Novo Nordisk disposable needle. Needles are not included with the Pen.
  • 2 alcohol swabs
  • flat surface like a table
  • a sharps disposal container. See Step 6 for information on how to dispose of used needles and syringes.

6 Steps you should follow for a Norditropin injection:

Step 1. Preparing the Norditropin NordiFlex Pen

Step 2. Attaching the needle to the Norditropin NordiFlex Pen

Step 3. Priming a new Pen

Step 4. Selecting the correct dose of Norditropin

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

Step 6. What to do after the injection is completed

Step 1. Preparing the Norditropin NordiFlex Pen.

  • Pull off the Pen cap. See Figure B.

Figure B

Pull off the Pen cap - Illustration

  • Look in the residual scale window. Check that the liquid medicine in the Pen is clear and colorless by tipping it upside down 1 or 2 times. If the liquid looks unclear or cloudy, do not use the Pen. See Figure C.

Figure C

Check the liquid - Illustration

  • Wash your hands well and dry them.
  • Wipe the front stopper on the needle thread with an alcohol swab. See Figure D.

Figure D

Wipe the front stopper - Illustration

Step 2. Attaching the needle to the Norditropin NordiFlex Pen.

  • Never place a needle on your Pen until you are ready to give an injection.
  • Take a new disposable needle and tear off the protective tab. See Figure E.

Figure E

Tear off the protective tab - Illustration

  • Holding the Pen with one 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 F.

Figure F

Screw the needle in - Illustration

  • Pull off the outer needle cap. See Figure G.

Figure G

Pull off the outer needle cap - Illustration

  • Pull off the inner needle cap and throw them both away. See Figure H.
  • If you try to put the needle caps back on, you may accidentally hurt yourself with the needle.
  • A drop of liquid may appear at the needle tip. This is normal.

Figure H

A drop of liquid may appear  - 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 first prepare it for use. Hold the Pen with one hand and turn the dosage selector clockwise to select 0.1 mg. You will hear a faint click when you turn the dosage selector. This is the smallest amount of medicine for a dose. See Figure I.

Figure I

Turn the dosage selector - Illustration

  • 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 J.

Figure J

Tap the top of the Pen gently - Illustration

  • Press the push button until the “0.0” in the residual scale window lines up with the pointer and a drop of liquid appears at the needle tip. See Figure K.

Figure K

Press the push button - Illustration

  • If no drop appears, repeat Step 3 again up to 6 times.
  • If you still do not see a drop of liquid, change the needle and repeat Step 3 again.
  • If a drop of liquid still does not appear after repeating Step 3 and changing the needle, call Novo Nordisk at 1-888-668-6444 for help.

Step 4. Selecting the correct dose of Norditropin.

  • Use the dosage selector on your Norditropin NordiFlex Pen to make sure you have the exact dose selected. You can select up to 6 mg per dose.
  • To start, check that the pointer on the Pen is set at “0.0”. See Figure L.

Figure L

Select exact dose - Illustration

  • Select the dose you need by turning the dosage selector clockwise. If you go beyond your dose, turn the dosage selector counterclockwise until the right number of mg lines up with the pointer.
  • Use the dosage indicator, not the clicking sound, as a guide for selecting the dose.
  • When dialing counterclockwise, be careful not to press the push button as liquid will come out.
  • You can use the residual scale window on the side of the Pen to see approximately how much growth hormone is left in the Pen. You can also use the dosage selector to see exactly how much growth hormone is left in the Pen.
  • If the Pen contains less than 6 mg, turn the dosage selector until it stops. The number that lines up with the pointer shows how many mg is 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 to deliver your full dose, use a new Norditropin NordiFlex 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 0.6 mg and you can only set the dosage selector to 0.3 mg, you should inject another 0.3 mg with a new Norditropin NordiFlex Pen. See Figure L.

Important:

  • Never use the Pen clicks to count the number of mg you select. Only t he dosage indicator window and pointer will show the exact number.
  • Never use the residual scale window to measure how much liquid to inject. Only the dosage indicator window and pointer will show the exact number.

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

  • Change the injection site every day.
  • Select the injection site and wipe the skin with an alcohol swab as your healthcare provider showed you.
  • Insert the needle under the skin as your healthcare provider showed you. See Figure M.

Figure M

Insert the needle - Illustration

  • After inserting the needle into the skin, press the push button in as far as it will go to give the dose until the “0.0” in the dosage indicator window lines up with the pointer. As you do this, you may hear a click. See Figure M.
  • If you remove your finger from the push button before the “0.0” is in the dosage indicator window the full dose has not been received. Leave the needle in the skin and press the push button again until the “0.0” lines up with the pointer.

If the push button cannot be pushed in completely or “0.0” does not appear in the dosage indicator 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 “0.0” in the dosage indicator window lines up with the pointer, leave the needle under the skin for at least 6 seconds with your thumb on the push button to make sure that you get your full dose. Keep the push button fully pushed in until the needle has been removed from the skin.

Important:

  • Always press the push button to inject the dose. Turning the dosage selector will not inject the dose.
  • Never touch the dosage indicator window when you inject, as this can block the injection.
  • Carefully lift the pen to remove the needle from the skin. After that, you may see a drop of liquid at the needle tip. This is normal and does not affect the dose you received. See Figure N.

Figure N

Carefully lift the pen - Illustration

Step 6. What to do after the injection is completed.

  • Do not recap the needle. Recapping a needle can lead to a needle stick injury. Remove the needle from the Pen after each injection.
  • Carefully remove the needle from the Pen by turning the needle in a counterclockwise direction. See Figure O.

Figure O

Carefully remove the needle - Illustration

  • Put the Pen cap back on.
  • If there is medicine left in the Pen, store the Pen as directed in the Patient Information that comes with this Pen.
  • If the Pen is empty, throw the Pen away as directed below. Put your used needles and Pen 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: 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.

Care of your Norditropin NordiFlex Pen:

You must take care of your Norditropin NordiFlex Pen:

  • Do not drop your Pen or knock it against hard surfaces. If you drop it or think that something is wrong with it, always screw on a new disposable needle and check the growth hormone flow (priming) before you inject.
  • Do not try to refill your Pen. It is prefilled.
  • Do not try to repair your Pen or pull it apart.
  • Do not expose your Pen to dust, dirt or any kind of liquid.
  • Do not try to wash, soak or lubricate your Pen. Clean the Norditropin NordiFlex Pen with a mild detergent on a moistened cloth.
  • Always keep your Pen and needles out of reach of others, especially children.

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

Last reviewed on RxList: 10/29/2013
This monograph has been modified to include the generic and brand name in many instances.

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