NORDITROPINinjection is a clear and colorless solution available as follows:

•

5 mg in 1.5 mL (orange): NORDITROPINFlexPro single-patient-use pen

•

10 mg in 1.5 mL (blue): NORDITROPIN FlexPro single-patient-use pen

•

15 mg in 1.5 mL (green): NORDITROPIN FlexPro single-patient-use pen

•

30 mg in 3 mL (purple): NORDITROPIN FlexPro single-patient-use pen

NORDITROPIN is contraindicated in patients with:

•

Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see Warnings and Precautions (5.1)].

•

Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions (5.2)].

•

Active Malignancy [see Warnings and Precautions (5.3)].

•

Hypersensitivity to NORDITROPIN or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products [see Warnings and Precautions (5.6)].

•

Active proliferative or severe non-proliferative diabetic retinopathy.

•

Pediatric patients with closed epiphyses.

The following important adverse reactions are also described elsewhere in the labeling:

•

Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1)]

•

Sudden death in children with Prader-Willi syndrome [see Warnings and Precautions (5.2)]

•

Neoplasms [see Warnings and Precautions (5.3)]

•

Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4)]

•

Intracranial hypertension [see Warnings and Precautions (5.5)]

•

Severe hypersensitivity [see Warnings and Precautions (5.6)]

•

Fluid retention [see Warnings and Precautions (5.7)]

•

Hypoadrenalism [see Warnings and Precautions (5.8)]

•

Hypothyroidism [see Warnings and Precautions (5.9)]

•

Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.10)]

•

Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.11)]

•

Pancreatitis [see Warnings and Precautions (5.12)]

•

Lipoatrophy [see Warnings and Precautions (5.13)]

Table 2 includes a list of drugs with clinically important drug interactions when administered concomitantly with NORDITROPINand instructions for preventing or managing them.

Table 2: Clinically Important Drug Interactions with NORDITROPIN

Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with somatropin is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone.

NORDITROPIN(somatropin) for injection is a recombinant human growth hormone. It is a polypeptide of recombinant DNA origin and is synthesized by a special strain of E. coli bacteria that has been modified by the addition of a plasmid which carries the gene for human growth hormone. NORDITROPINcontains the identical sequence of 191 amino acids constituting the naturally occurring pituitary human growth hormone with a molecular weight of about 22,000 Daltons.

NORDITROPINis supplied as a sterile solution for subcutaneous use in ready-to-administer prefilled pens with a volume of 1.5 mL or 3 mL.

Each NORDITROPINcontains the following (see Table 3):

Table 3

NORDITROPINinjection is a clear and colorless solution available as FlexPro prefilled pens:

•

NORDITROPINFlexPro 5 mg/1.5 mL (orange) NDC 0169-7704-21

•

NORDITROPIN FlexPro 10 mg/1.5 mL (blue) NDC 0169-7705-21

•

NORDITROPIN FlexPro 15 mg/1.5 mL (green) NDC 0169-7708-21

•

NORDITROPIN FlexPro 30 mg/3 mL (purple) NDC 0169-7703-21

Each NORDITROPIN FlexPro pen is for use by a single patient. A NORDITROPIN FlexPro pen must never be shared between patients, even if the needle is changed.

Unused NORDITROPINFlexPro prefilled pensmust be stored at 2°C to 8°C/36°F to 46°F (refrigerator). Do not freeze. Avoid direct light.

Table 14 – Storage Conditions and Expiration

See FDA-approved patient labeling.

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

•

Neoplasms – Advise childhood cancer survivors/caregivers that individuals treated with brain/head radiation are at increased risk of secondary neoplasms and as a precaution need to be monitored for recurrence. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of pre-existing nevi.

•

Fluid Retention - Advise patients that fluid retention during NORDITROPINreplacement therapy in adults may frequently occur. Inform patients of the clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) and to report to their healthcare provider any of these signs or symptoms occur during treatment with NORDITROPIN.

•

Pancreatitis - Advise patients/caregivers that pancreatitis may develop and to report to their healthcare provider any new onset abdominal pain.

•

Hypoadrenalism - Advise patients/caregivers who have or who are at risk for pituitary hormone deficiency(s) that hypoadrenalism may develop and to report to their healthcare provider if they experience hyperpigmentation, extreme fatigue, dizziness, weakness, or weight loss.

•

Hypothyroidism - Advise patients/caregivers that undiagnosed/untreated hypothyroidism may prevent an optimal response to NORDITROPIN. Advise patients/caregivers they may require periodic thyroid function tests.

•

Intracranial Hypertension - Advise patients/caregivers to report to their healthcare provider any visual changes, headache, and nausea and/or vomiting.

•

Hypersensitivity Reactions – Advise patients/caregivers that serious systemic hypersensitivity reactions (anaphylaxis and angioedema) are possible and that prompt medical attention should be sought if an allergic reaction occurs.

•

Glucose Intolerance/ Diabetes Mellitus – Advise patients/caregivers that new onset impaired glucose intolerance/diabetes mellitus or exacerbation of preexisting diabetes mellitus can occur and monitoring of blood glucose during treatment with NORDITROPINmay be needed.

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

NORDITROPIN® and FlexPro® are registered trademarks of Novo Nordisk Health Care AG.

© 2002-2020 Novo Nordisk Health Care AG

For information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, New Jersey 08536, USA

1-888-668-6444

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

 NORDITROPIN® (Nor-dee-tro-pin)

(somatropin) 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, Turner syndrome, or were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years.

•

children who have Idiopathic Short Stature (ISS).

•

children who are not growing who have Prader-Willi syndrome (PWS).

•

adults who do not make enough growth hormone.

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 (briefly stop breathing during sleep).

•

you have cancer or other tumors.

•

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.

•

your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy).

•

you are a child with closed bone growth plates (epiphyses). 

Before taking  NORDITROPIN, tell your healthcare provider about all of your medical conditions, including if you:

•

have had heart or stomach surgery, trauma or serious breathing (respiratory) problems.

•

have had a history of problems breathing while you sleep (sleep apnea).

•

have or have had cancer or any tumor.

•

have diabetes.

•

are pregnant or plan to become pregnant. It is not known if NORDITROPIN will harm your unborn baby. Talk to your healthcare provider 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 over-the-counter 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 are for use by 1 person only.

•

Do not share your NORDITROPIN pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them.

What are the possible side effects of NORDITROPIN?

NORDITROPIN may 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 sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea.

•

increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your or your child’s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child starts to have headaches, or have changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of your skin.

•

new or worsening high blood sugar (hyperglycemia) or diabetes. Your or your child’s blood sugar may need to be monitored during treatment with NORDITROPIN.

•

increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the healthcare provider.

•

serious allergic reactions. Get medical help right away if you or your child has the following symptoms:

o

swelling of your face, lips, mouth, or tongue

o

trouble breathing

o

wheezing

o

severe itching

o

skin rashes, redness, or swelling

o

dizziness or fainting

o

fast heartbeat or pounding in your chest

o

sweating

•

your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in adults during treatment with NORDITROPIN. Tell your healthcare provider if you have any of these signs or symptoms of fluid retention.

•

decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s healthcare provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss.

•

decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well NORDITROPIN works. The healthcare provider will do blood tests to check your or your child’s thyroid hormone levels.

•

hip and knee pain or a limp in children (slipped capital femoral epiphysis)

•

worsening of curvature of the spine (scoliosis)

•

severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain.

•

loss of fat and tissue weakness in the area of skin you inject. Talk to your healthcare provider about rotating the areas where you inject NORDITROPIN.

•

increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your or your child’s healthcare provider will do blood tests to check this.

The most common side effects of NORDITROPIN include:

•

injection site reactions and rashes

•

headaches

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. You may also report side effects to Novo Nordisk at 1-888-668-6444.

How should I store NORDITROPIN?

•

Before you use NORDITROPIN FlexPro pens for the first time:

o

Store your new, unused NORDITROPIN pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).

o

Do not freeze NORDITROPIN.

o

Keep NORDITROPIN away from direct light.

o

Do not use NORDITROPIN that has been frozen or in temperatures warmer than 77ºF (25ºC).

o

Do not use NORDITROPIN after the expiration date printed on the carton and the pen.

•

After you use NORDITROPIN FlexPro pens and there is still medicine left:

o

Store remaining NORDITROPIN in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or

o

Store remaining NORDITROPIN at room temperature no warmer than 77ºF (25ºC) 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. 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. You can ask your pharmacist or healthcare provider for information about NORDITROPIN that is written for health professionals.

What are the ingredients in NORDITROPIN?

Active ingredient: somatropin

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

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

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

Revised: 02/2018

INSTRUCTIONS FOR USE

Norditropin® (Nor-dee-tro-pin) FlexPro®

(somatropin) injection

5 mg/1.5 mL

Norditropin FlexPro Pen is for single-patient-use only.

Supplies you will need:

•

Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm

•

sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.

•

alcohol pad

•

gauze pad

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 see:

 

Frequently Asked Questions

 

Important information

 

Patient Information

Important information

Make sure that you read this information carefully.

Additional 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 giving 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 1 or 2 times 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.

•

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

•

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

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.

•

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.

Never use a bent or damaged needle.

Step 2. Check the Norditropin flow with each new Pen

If your Pen is already in use, go 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 1 tick marking on the dose counter to select 0.025 mg. You will hear a faint “click” when you turn the dose selector. See figure E.

•

1 marking on the dose counter equals 0.025 mg. See figure F.

•

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.

•

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:

•

Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.

•

and repeat step 2 again.

 

Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at

 

1-888-668-6444 for help.

Step 3. Select your dose

•

To start, check that the dose pointer 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 go to step 4.

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

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 use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.

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 forcefully move it past the number of “mg” left in the Pen.

Step 4. Inject your dose

•

Select the injection site.

•

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

•

Wipe the injection site with an alcohol swab and let the area dry.

•

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.

•

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.

•

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.

•

Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. 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.

Step 5. After your injection

•

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

•

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

Always dispose of the needle after each injection.

 

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

 

Do not try to put the needle cap 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.

 

See “How should I store Norditropin?”.

 

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

 

How should I store Norditropin?

•

Before you use Norditropin FlexPro pens for the first time:

o

Store your new, unused Norditropin pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).

o

Do not freeze Norditropin.

o

Keep Norditropin away from direct light.

o

Do not use Norditropin that has been frozen or in temperatures warmer than 77ºF (25ºC).

o

Do not use Norditropin after the expiration date printed on the carton and the pen.

•

After you use Norditropin FlexPro pens and there is still medicine left:

o

Store remaining Norditropin in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or

o

Store remaining Norditropin at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks.

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

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 T below.

To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 2.0 mg. If the dose counter stops with the dose pointer lined up with “2.0” , at least 2.0 mg are left in your Pen.

If the dose counter stops with the dose pointer lined up with “1.25”, only 1.25 mg are left in your Pen. See figure U below.

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

It is not possible to select a larger dose on the dose counter than the number 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 split your dose if you have been trained or advised by your healthcare provider on how to do this. You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.

Be very careful to calculate your split dose correctly so that you do not give the wrong dose. 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?

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

If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.

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.

See “How should I store Norditropin?”.

Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “How do I dispose of used needles and Pens?”.

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 used needles and Pens?

Put your used needles in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash. If you do not have 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.

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 dispose of used needles and Pens. For more information about safe sharps disposal, and 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.

When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.

Important information

•

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

•

Norditropin® FlexPro® 5 mg/1.5 mL Pen is compatible with FlexPro® PenMate®.

www.norditropin.com

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

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

Norditropin® and FlexPro® are registered trademarks of Novo Nordisk Health Care AG.

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

© 2004-2020 Novo Nordisk Health Care AG

For further information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536, USA

1-888-668-6444

norditropin-us.com

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd

Denmark

Revised 3/2020

INSTRUCTIONS FOR USE

Norditropin® (Nor-dee-tro-pin) FlexPro®

(somatropin) injection

10 mg/1.5 mL

Norditropin FlexPro Pen is for single-patient-use only.

Supplies you will need:

•

Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm.

•

sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.

•

alcohol pad

•

gauze pad

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 see:

 

Frequently Asked Questions

 

Important information

 

Patient Information

Important information

Make sure that you read this information carefully.

Additional 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 giving 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 1 or 2 times 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.

•

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

•

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

 

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.

•

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.

 

Never use a bent or damaged needle.

Step 2. Check the Norditropin flow with each new Pen

If your Pen is already in use, go 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 1 tick marking on the dose counter to select 0.05 mg. You will hear a faint “click” when you turn the dose selector. See figure E.

•

1 marking on the dose counter equals 0.05 mg. See figure F.

•

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.

•

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:

•

Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.

•

and repeat step 2 again.

 

Do not use the Pen if a drop of Norditropin still does not appear after changing the needle and repeating step 2. Call Novo Nordisk at

 

1-888-668-6444 for help.

Step 3. Select your dose

•

To start, check that the dose pointer 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 go to step 4.

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

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 use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.

 

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 forcefully move it past the number of “mg” left in the Pen.

Step 4. Inject your dose

•

Select the injection site.

•

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

•

Wipe the injection site with an alcohol swab and let the area dry.

•

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.

•

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.

•

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.

•

Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. 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.

Step 5. After your injection

•

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

•

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

Always dispose of the needle after each injection.

 

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

Do not try to put the needle cap 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.

 

See “How should I store Norditropin?”.

 

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

 

How should I store Norditropin?

•

Before you use Norditropin FlexPro pens for the first time:

o

Store your new, unused Norditropin pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).

o

Do not freeze Norditropin.

o

Keep Norditropin away from direct light.

o

Do not use Norditropin that has been frozen or in temperatures warmer than 77ºF (25ºC).

o

Do not use Norditropin after the expiration date printed on the carton and the pen.

•

After you use Norditropin FlexPro pens and there is still medicine left:

o

Store remaining Norditropin in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or

o

Store remaining Norditropin at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks.

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

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 T below.

To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 4.0 mg. If the dose counter stops with the dose pointer lined up with “4.0” , at least 4.0 mg are left in your Pen.

If the dose counter stops with the dose pointer lined up with “2.4”, only 2.4 mg are left in your Pen. See figure U below.

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

It is not possible to select a larger dose on the dose counter than the number 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 split your dose if you have been trained or advised by your healthcare provider on how to do this. You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.

Be very careful to calculate your split dose correctly so that you do not give the wrong dose. 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?

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

If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.

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.

See “How should I store Norditropin?”.

Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “How do I dispose of used needles and Pens?”.

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 used needles and Pens?

Put your used needles in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash. If you do not have 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.

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 dispose of used needles and Pens. For more information about safe sharps disposal, and 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.

When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.

Important information

•

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

•

Norditropin® FlexPro® 10 mg/1.5 mL Pen is compatible with FlexPro® PenMate®.

www.norditropin.com

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

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

Norditropin® and FlexPro® are registered trademarks of Novo Nordisk Health Care AG.

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

© 2004-2020 Novo Nordisk Health Care AG

For further information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536, USA

1-888-668-6444

norditropin-us.com

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd

Denmark

Revised 3/2020

INSTRUCTIONS FOR USE

Norditropin® (Nor-dee-tro-pin) FlexPro®

(somatropin) injection

15 mg/1.5 mL

Norditropin FlexPro Pen is for single-patient-use only.

Supplies you will need:

•

Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm

•

sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.

•

alcohol pad

•

gauze pad

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 see:

 

Frequently Asked Questions

 

Important information

 

Patient Information

Important information

Make sure that you read this information carefully.

Additional 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 giving 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 1 or 2 times 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.

•

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

•

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

 

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.

•

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.

 

Never use a bent or damaged needle.

Step 2. Check the Norditropin flow with each new Pen

If your Pen is already in use, go 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 1 tick marking on the dose counter to select 0.1 mg. You will hear a faint “click” when you turn the dose selector. See figure E.

•

1 marking on the dose counter equals 0.1 mg. See figure F.

•

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.

•

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:

•

Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.

•

and repeat step 2 again.

 

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

Step 3. Select your dose

•

To start, check that the dose pointer 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 go to step 4.

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

 

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 use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.

 

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 forcefully move it past the number of “mg” left in the Pen.

Step 4. Inject your dose

•

Select the injection site.

•

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

•

Wipe the injection site with an alcohol swab and let the area dry.

•

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.

•

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.

•

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.

•

Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. 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.

Step 5. After your injection

•

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

•

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

Always dispose of the needle after each injection.

 

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

Do not try to put the needle cap 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.

 

See “How should I store Norditropin?”.

 

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

 

How should I store Norditropin?

•

Before you use Norditropin FlexPro pens for the first time:

o

Store your new, unused Norditropin pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).

o

Do not freeze Norditropin.

o

Keep Norditropin away from direct light.

o

Do not use Norditropin that has been frozen or in temperatures warmer than 77ºF (25ºC).

o

Do not use Norditropin after the expiration date printed on the carton and the pen.

•

After you use Norditropin FlexPro pens and there is still medicine left:

o

Store remaining Norditropin in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or

o

Store remaining Norditropin at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks.

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

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 T below.

To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 8.0 mg. If the dose counter stops with the dose pointer lined up with “8.0” , at least 8.0 mg are left in your Pen.

If the dose counter stops with the dose pointer lined up with “3.8”, only 3.8 mg are left in your Pen. See figure U below.

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

It is not possible to select a larger dose on the dose counter than the number 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 split your dose if you have been trained or advised by your healthcare provider on how to do this. You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.

Be very careful to calculate your split dose correctly so that you do not give the wrong dose. 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?

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

If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.

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.

See “How should I store Norditropin?”.

Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “How do I dispose of used needles and Pens?”.

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 used needles and Pens?

Put your used needles in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash. If you do not have 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.

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 dispose of used needles and Pens. For more information about safe sharps disposal, and 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.

When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.

Important information

•

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

•

Norditropin® FlexPro® 15 mg/1.5 mL Pen is compatible with FlexPro® PenMate®.

www.norditropin.com

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

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

Norditropin® and FlexPro® are registered trademarks of Novo Nordisk Health Care AG.

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

© 2004-2020 Novo Nordisk Health Care AG

For further information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536, USA

1-888-668-6444

norditropin-us.com

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd

Denmark

Revised 3/2020

INSTRUCTIONS FOR USE

Norditropin® (Nor-dee-tro-pin) FlexPro®

(somatropin) injection

30 mg/3 mL

Norditropin FlexPro Pen is for single-patient-use only.

Supplies you will need:

•

Norditropin FlexPro prefilled Pen new injection needle. Norditropin prefilled Pen is designed to be used with all Novo Nordisk disposable needles up to a length of 8 mm

•

sharps disposal container. See step 5 for information on how to throw away (dispose of) used needles and Pens.

•

alcohol pad

•

gauze pad

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 see:

 

Frequently Asked Questions

 

Important information

 

Patient Information

Important information

Make sure that you read this information carefully.

Additional 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 giving 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 1 or 2 times 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.

•

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

•

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

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.

•

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.

 

Never use a bent or damaged needle.

Step 2. Check the Norditropin flow with each new Pen

If your Pen is already in use, go 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 1 tick marking on the dose counter to select 0.1 mg. You will hear a faint “click” when you turn the dose selector. See figure E.

•

1 marking on the dose counter equals 0.1 mg. See figure F.

•

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.

•

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:

•

Carefully remove the needle from the Pen by turning the needle counterclockwise. Place the needle in a sharps disposal container immediately. See step 5.

•

and repeat step 2 again.

 

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

Step 3. Select your dose

•

To start, check that the dose pointer 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 go to step 4.

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

 

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 use the “click” sounds you hear when you turn the dose selector or the Pen scale to select your dose. Only the dose pointer on the dose counter will show the exact dose selected.

 

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 forcefully move it past the number of “mg” left in the Pen.

Step 4. Inject your dose

•

Select the injection site.

•

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

•

Wipe the injection site with an alcohol swab and let the area dry.

•

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.

•

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.

•

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.

•

Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly with a gauze pad. 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.

Step 5. After your injection

•

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

•

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

Always dispose of the needle after each injection.

 

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

Do not try to put the needle cap 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.

 

See “How should I store Norditropin?”.

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

 

How should I store Norditropin?

•

Before you use Norditropin FlexPro pens for the first time:

o

Store your new, unused Norditropin pen in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).

o

Do not freeze Norditropin.

o

Keep Norditropin away from direct light.

o

Do not use Norditropin that has been frozen or in temperatures warmer than 77ºF (25ºC).

o

Do not use Norditropin after the expiration date printed on the carton and the pen.

•

After you use Norditropin FlexPro pens and there is still medicine left:

o

Store remaining Norditropin in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) and use within 4 weeks, or

o

Store remaining Norditropin at room temperature no warmer than 77ºF (25ºC) and use within 3 weeks.

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

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 T below.

To see how much Norditropin is left in your Pen, use the dose counter: Turn the dose selector clockwise until the dose counter stops. The dose pointer will line up with the number of “mg” left in the Pen. You can select a maximum dose of 8.0 mg. If the dose counter stops with the dose pointer lined up with “8.0” , at least 8.0 mg are left in your Pen.

If the dose counter stops with the dose pointer lined up with “3.8”, only 3.8 mg are left in your Pen. See figure U below.

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

It is not possible to select a larger dose on the dose counter than the number 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 split your dose if you have been trained or advised by your healthcare provider on how to do this. You may find it helpful to use a calculator to plan the doses as instructed by your healthcare provider.

Be very careful to calculate your split dose correctly so that you do not give the wrong dose. 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?

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

If “0” still does not appear after completing the injection, contact Novo Nordisk at 1-888-668-6444.

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.

See “How should I store Norditropin?”.

Do not try to refill your Pen, it is already prefilled. When your Pen is empty, throw it away and use a new pen. See “How do I dispose of used needles and Pens?”.

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 used needles and Pens?

Put your used needles in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash. If you do not have 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.

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 dispose of used needles and Pens. For more information about safe sharps disposal, and 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.

When there is not enough medicine left in your Pen for your prescribed dose, the Pen may be thrown away in your household trash after you have removed the needle.

Important information

•

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

•

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

www.norditropin.com

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

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

Norditropin® and FlexPro® are registered trademarks of Novo Nordisk Health Care AG.

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

© 2004-2020 Novo Nordisk Health Care AG

For further information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536, USA

1-888-668-6444

norditropin-us.com

Manufactured by:

Novo Nordisk A/S

DK-2880 Bagsvaerd

Denmark

Revised 3/2020

INSTRUCTIONS FOR USE

Norditropin® (Nor-dee-tro-pin) FlexPro®

(somatropin) 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.

Figure A

Figure B

Figure C

Figure D

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 Pen cap and throw it away.

 

See figure F.

You will not need the Pen cap with your PenMate.

Figure F

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

 

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

 

See figure H.

Figure H

 

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

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

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

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 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

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

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

See figure O.

Figure O

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

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

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

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

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

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 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

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

 

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

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

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

See figure Z.

Figure Z

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

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

Insert the new Pen into your PenMate.

See figure CC.

Figure CC

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

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:

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, and

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 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, USA

Visit norditropin-us.com

Or call: 1-888-668-6444

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

Novo Nordisk®, PenMate® and NovoFine® are registered trademarks of Novo Nordisk A/S.

Norditropin® and FlexPro® are registered trademarks of Novo Nordisk Health Care AG.

© 2015-2017 Novo Nordisk A/S

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

Manufactured by:

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

Revised: 08/2017

Norditropin®  FlexPro®

(somatropin) injection

5 mg/1.5 mL Prefilled Pen

1 x 1.5 mL prefilled pen

Each 1.5 mL contains 5 mg somatropin

CONTAINS ONE

NORDITROPIN® FlexPro® 5 mg/1.5 mL

Single patient use only

Rx only

NDC 0169-7704-21

List: 770421

Norditropin®  FlexPro®

(somatropin) injection

10 mg/1.5 mL Prefilled Pen

1 x 1.5 mL prefilled disposable pen

Each 1.5 mL contains 10 mg somatropin

CONTAINS ONE

NORDITROPIN® FlexPro® 10 mg/1.5 mL

Single patient use only

Rx only

NDC 0169-7705-21

List: 770521

Norditropin®  FlexPro®

(somatropin) injection

15 mg/1.5 mL Prefilled Pen

1 x 1.5 mL prefilled disposable pen

Each 1.5 mL contains 15 mg somatropin

CONTAINS ONE

NORDITROPIN® FlexPro® 15 mg/1.5 mL

Single patient use only

Rx only

NDC 0169-7708-21

List: 770821

Norditropin® FlexPro®

(somatropin) injection

30 mg / 3 mLPrefilled Pen

1x3 mL prefilled pen

Each 3 mL contains: 30 mg somatropin

CONTAINS ONE NORDITROPIN® FlexPro® 30 mg / 3 mL

Single patient use only

Rx only

NDC 0169-7703-21

List: 770321