Norditropin Flexpro: Uses, Side Effects and Dosage

What NORDITROPIN^® is used for:

Children:

• NORDITROPIN^® is used for the long-term treatment of children with growth failure due to an inability to produce adequate amounts of growth hormone.
• NORDITROPIN^® is used for the treatment of children with short stature born small for gestational age (SGA) with no catch-up growth by age 2.
• NORDITROPIN^® is used for the treatment of children who are short (in stature) and who have Turner syndrome.
• NORDITROPIN^® is used for the treatment of children who are short (in stature) and who have Noonan syndrome.

How NORDITROPIN^® works:

NORDITROPIN^® provides growth hormone for children unable to produce adequate amounts of growth hormone naturally.

NORDITROPIN^® may produce bone growth in children where the ends of the long bones have not yet hardened. NORDITROPIN^® has many effects on growth and metabolism.

The ingredients in NORDITROPIN^® are:

Medicinal ingredients: Somatropin (recombinant human growth hormone)

Non-medicinal ingredients: histidine, mannitol, phenol, poloxamer 188 and water for injections

Serious Warnings and Precautions

• NORDITROPIN^® therapy should be carried out under the regular guidance of a doctor who is experienced in the diagnosis and management of patients with growth disorders.
• There have been reports of deaths in children with Prader-Willi syndrome who were treated with growth hormone and had one or more of the following risk factors: severely obese, breathing problems or colds and lung infections.

NORDITROPIN^® comes in the following dosage forms:

NORDITROPIN^® FlexPro^® is available as a pre-filled disposable pen in 3 colour coded strengths:

• 5 mg / 1.5 mL pen with an orange pen cap and push button
• 10 mg / 1.5 mL pen with a blue pen cap and push button
• 15 mg / 1.5 mL pen with a green pen cap and push button

Do not use NORDITROPIN^® if:

• The child has acute critical illness caused by open heart or stomach surgery, major injuries, or acute breathing (respiratory) problems. In these situations, treatment with growth hormone may increase the risk of death.
• The child’s growth areas of the bones have closed (closed epiphyses) and cannot grow any longer.
• The child has active cancer or other tumours. Cancer treatment must be finished before starting treatment with NORDITROPIN^®. Stop NORDITROPIN^® treatment if evidence of cancer develops.
• The child has Prader-Willi syndrome. There have been reports of deaths in children with Prader-Willi syndrome who were treated with growth hormone and had one or more of the following risk factors: severely obese, breathing problems or colds and lung infections.
• The child is allergic to any of the ingredients in NORDITROPIN^® (see The ingredients in NORDITROPIN^® are) or to any component of the container.

To help avoid side effects and ensure proper use, talk to your child’s healthcare professional before your child takes NORDITROPIN^®. Talk about any health conditions or problems your child may have, including if your child:

• Has Prader-Willi syndrome and breathing problems, sleep apnea (not breathing while sleeping), snoring or a respiratory infection. NORDITROPIN^® is not approved for use in children with Prader-Willi syndrome.
• Has diabetes or a family history of diabetes. If the child is on insulin, the dose may need to be adjusted because NORDITROPIN^® may affect the body’s response to insulin.
• Is experiencing headache, nausea, visual changes and/or vomiting. These are symptoms of a condition called intracranial hypertension.
• Has ever had hypothyroidism (low levels of thyroid hormone), since NORDITROPIN^® may reduce the levels of thyroid hormone in the body.
• Has ever had scoliosis (a condition which affects the spine). Since growth hormone increases growth rate, patients who have ever had scoliosis who are treated with NORDITROPIN^® should be monitored for progression of scoliosis.
• Has ever had cancer or cardiovascular disorders (stroke, aortic aneurysm (abnormal dilatation of the aortic wall)/ dissection (rupture of the main blood vessels), and high blood pressure).

If your teenaged child becomes pregnant or is sexually active, talk to your child’s healthcare professional as it is not known if NORDITROPIN^® could cause harm to an unborn baby, or whether it can pass into breast milk when breastfeeding.

Other warnings you should know about:

Rarely, injection of growth hormone products under the skin (subcutaneous injection) can result in loss of fat and tissue weakness (lipoatrophy), or enlargement or thickening of fat tissue (lipohypertrophy) in the area of the skin you inject. Patients should be advised to consult their healthcare professional if they notice any of these conditions.

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

In children with Turner syndrome, a few cases of increased growth of hands and feet compared to height have been observed.

NORDITROPIN^® may cause a decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well NORDITROPIN^® works. Your child’s healthcare professional will do blood tests to check your child’s thyroid hormone levels.

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

NORDITROPIN^® may cause an increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your child’s healthcare professional will do blood tests to check this.

Tell your child’s healthcare professional about all the medicines your child takes, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with NORDITROPIN^®:

• Corticosteroids (steroids): Steroids may decrease the effects of NORDITROPIN^®. Doses of the steroid may need to be adjusted.
• Insulin: NORDITROPIN^® may affect the body’s response to insulin. Doses of insulin may need to be adjusted.

How to take NORDITROPIN^®:

NORDITROPIN^® therapy should be carried out under the regular guidance of a doctor who is experienced in the diagnosis and management of patients with growth disorders.

Usual dose:

Your child’s doctor will calculate the dose of NORDITROPIN^® most appropriate for your child, based on your child’s body weight.

Overdose:

If your child has been given too much NORDITROPIN^®, contact your healthcare professional, hospital emergency department, regional Poison Control Centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Short-term overdosage can lead to low blood glucose levels initially, followed by high blood glucose levels. Overdose is also likely to cause fluid retention.

Long-term overdosing can cause abnormal growth and coarsening of facial features.

Missed dose:

Missing doses can interfere with the effectiveness of the medication. Talk to your child’s doctor if this happens. If your child misses a dose, it is not recommended to double the next dose. Administer the regular dose at the next scheduled dosage time.

It is important to keep changing the injection site to minimize the risk of lipoatrophy.

Please see the section “INFORMATION ON HOW TO INJECT NORDITROPIN^® FLEXPRO^®”at the end of this leaflet.

Possible side effects from using NORDITROPIN^®:

These are not all the possible side effects your child may feel when taking NORDITROPIN^®. If your child experiences any side effects not listed here, contact their healthcare professional.

• Serious allergic reactions. Get medical help immediately if your child has the following symptoms: swelling of the face, lips, mouth, or tongue; trouble breathing; wheezing; severe itching; skin rashes, redness, or swelling; dizziness or fainting; fast heartbeat or pounding the chest; sweating.
• Redness and itching may appear at the injection site. If this appears to be particularly troublesome or if the injection area becomes painful, you should discuss this with your child’s doctor.
• Growth hormone like NORDITROPIN^® may bring about insulin resistance. Insulin resistance means your body cannot make good use of the insulin it produces. This causes higher levels of glucose in your blood. It is important to check your child’s blood glucose levels if your child has diabetes or a family history of diabetes.
• Nausea, vomiting, headache or visual changes. If your child experiences any of these side effects notify your child’s doctor.
• Breathing problems in patients with Prader-Willi syndrome. If your child has Prader-Willi syndrome and develops signs of breathing problems, sleep apnea (not breathing while sleeping) or new or increased snoring, contact your child’s doctor.
• Contact your child’s doctor if your child shows an unexplained limp, or complains of hip/knee pain. These symptoms may be a consequence of the end of the bone having slipped from the cartilage (slipped capital femoral epiphysis) or a disease affecting the top of the thigh bone (osteonecrosis of femoral head e.g., Legg-Calvé disease).
• Middle ear infection, hearing problems or ear problems in children with Turner syndrome. If your child experiences any of these side effects notify your child’s doctor.
• When treatment with NORDITROPIN^® is initiated, fluid retention with swelling of the hands and feet may occur. Mild joint pain, muscle pain and tingling or numbness of the hands and feet may also occur, but will usually improve without treatment.
• Breast enlargement (gynecomastia)
• In rare cases growth hormone treatment may cause an inflammation of the pancreas, which causes severe pain in the abdomen and back. Contact your doctor if your child develops severe stomach-ache after taking NORDITROPIN^®.

Serious side effects and what to do about them

If your child has a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with their daily activities, talk to your child’s healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Before you use NORDITROPIN^® FlexPro^® pens for the first time:

• Store your new, unused NORDITROPIN^® pen in a refrigerator between 2°C to 8°C.
• Do not freeze or expose NORDITROPIN^® to heat. Do not store close to any cooling element in the refrigerator. Do not use if frozen.
• 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:

• Store remaining NORDITROPIN^® in the refrigerator between 2°C to 8°C and use within 4 weeks, or
• Store remaining NORDITROPIN^® at room temperature up to 25°C and use within 3 weeks.
• Do not use NORDITROPIN^® which has been frozen or exposed to excessive temperatures.

Keep out of reach and sight of children.

If you want more information about NORDITROPIN^®:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.novonordisk.ca or by calling Novo Nordisk Canada Inc., at: 1-800-465-4334.

NORDITROPIN^® and FlexPro^® are registered trademarks of Novo Nordisk Health Care AG and are used under license by Novo Nordisk Canada Inc.

NovoFine^® is a registered trademark of Novo Nordisk A/S and is used under license by Novo Nordisk Canada Inc.

© 2025

Novo Nordisk Canada Inc.

Date of Authorization: April 20, 2026

INFORMATION ON HOW TO INJECT NORDITROPIN^® FLEXPRO^®

Instructions on how to use NORDITROPIN^® FlexPro^®

Please read these instructions carefully before using your NORDITROPIN^® FlexPro^® pen.

Start by checking the name, strength and coloured label of your NORDITROPIN^® FlexPro^® pen to make sure that it contains the growth hormone strength you need.

Read on to learn about:

Preparing your NORDITROPIN^® FlexPro^® pen

Checking the growth hormone flow with each new pen

Selecting your dose

Injecting your dose

Caring for your NORDITROPIN^® FlexPro^® pen

Important information

Pen cap Growth hormone scale Pointer Dose selector Dose button Needle (example) Needle Outer needle cap Inner needle cap Paper tab Norditropin® FlexPro® Display

Your NORDITROPIN^® FlexPro^® pen is a pre-filled growth hormone pen.

For NORDITROPIN^® FlexPro^® 5 mg / 1.5 mL, the pen contains 5 mg human growth hormone solution and delivers doses from 0.025 mg to 2.0 mg, in increments of 0.025 mg.

For NORDITROPIN^® FlexPro^® 10 mg / 1.5 mL, the pen contains 10 mg human growth hormone solution and delivers doses from 0.05 mg to 4.0 mg, in increments of 0.05 mg.

For NORDITROPIN^® FlexPro^® 15 mg / 1.5 mL, the pen contains 15 mg human growth hormone solution and delivers doses from 0.1 mg to 8.0 mg, in increments of 0.1 mg.

NORDITROPIN^® FlexPro^® is designed to be used with NovoFine^® or NovoFine^® Plus disposable needles up to a length of 8 mm.

Preparing your NORDITROPIN^® FlexPro^® pen

Check the name, strength and coloured label of your NORDITROPIN^® FlexPro^® pen to make sure that it contains the growth hormone strength you need.

1. A.

   Pull off the pen cap.

   Check that the growth hormone solution in the pen is

   clear and colourless by tipping it upside down once or

   twice. If the solution looks unclear or cloudy, do not use the pen.

A

B. Take a new disposable needle. Tear the paper tab off and screw the needle straight onto the pen. Make sure the needle is on tight.		B
		Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of growth hormone, blocked needles and inaccurate dosing. Never bend or damage the needle.
C. Pull off the outer needle cap and save it. After injection, you will need it to correctly remove the needle from the pen.		C
D. Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle. A drop of growth hormone may appear at the needle tip. This is normal.		D
Checking the growth hormone flow with each new pen Make sure that you receive your full dose by checking the growth hormone flow before you select and inject your first dose with each new pen.
E. For NORDITROPIN® FlexPro® 5 mg / 1.5 mL, turn the dose selector to select the minimum dose, 0.025 mg. For NORDITROPIN® FlexPro® 10 mg / 1.5 mL, turn the dose selector to select the minimum dose, 0.05 mg. For NORDITROPIN® FlexPro® 15 mg / 1.5 mL, turn the dose selector to select the minimum dose, 0.1 mg.		E 0.025 mg selected
F. Hold the pen with the needle pointing up. Tap the top of the pen a few times to let any air bubbles rise to the top.		F
G. Press the dose button until the figure 0 in the display lines up with the pointer and a drop of growth hormone appears at the needle tip. If no drop appears, repeat steps E to G up to 6 times. If no drop appears after these new attempts, change the needle and repeat steps E to G once more. Do not use the pen if a drop of growth hormone still does not appear.		G
		Always make sure that a drop appears at the needle tip before you inject your first dose with each new pen.
Selecting your dose For NORDITROPIN® FlexPro® 5 mg / 1.5 mL, use the dose selector on your NORDITROPIN® FlexPro® pen to select up to 2.0 mg per dose. For NORDITROPIN® FlexPro® 10 mg / 1.5 mL, use the dose selector on your NORDITROPIN® FlexPro® pen to select up to 4.0 mg per dose. For NORDITROPIN® FlexPro® 15 mg / 1.5 mL, use the dose selector on your NORDITROPIN® FlexPro® pen to select up to 8.0 mg per dose.
H. Select or adjust the dose you need by turning the dose selector forwards or backwards until the right number of mg lines up with the pointer. For NORDITROPIN® FlexPro® 5 mg / 1.5 mL, when the pen contains less than 2.0 mg, the dose selector stops at the number of mg left. For NORDITROPIN® FlexPro® 10 mg / 1.5 mL, when the pen contains less than 4.0 mg, the dose selector stops at the number of mg left. For NORDITROPIN® FlexPro® 15 mg / 1.5 mL, when the pen contains less than 8.0 mg, the dose selector stops at the number of mg left.		H 0.35 mg selected 1.475 mg selected
		The dose selector clicks differently when turned forwards, backwards or past the number of mg left.
		How much growth hormone is left?

You can use the growth hormone scale to see approximately how much growth hormone is left in the pen.

For NORDITROPIN^® FlexPro^® 5 mg / 1.5 mL, you can use the dose selector to see exactly how much growth hormone is left – if the pen contains less than 2.0 mg:

Turn the dose selector until it stops. The figure that lines up with the pointer shows how many mg are left.

For NORDITROPIN^® FlexPro^® 10 mg / 1.5 mL, you can use the dose selector to see exactly how much growth hormone is left – if the pen contains less than 4.0 mg:

Turn the dose selector until it stops. The figure that lines up with the pointer shows how many mg are left.

For NORDITROPIN^® FlexPro^® 15 mg / 1.5 mL, you can use the dose selector to see exactly how much growth hormone is left – if the pen contains less than 8.0 mg:

Turn the dose selector until it stops. The figure that lines up with the pointer shows how many mg are left.

If you need more growth hormone 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.

Never use the pen clicks to count the number of mg you select. Only the display and pointer will indicate the exact number of mg.

Never use the growth hormone scale to measure how much growth hormone to inject.

Only the display and pointer will indicate the exact number of mg.

Injecting your dose

Make sure that you receive your full dose by using the right injection technique.

1. I.

   Insert the needle into your skin as your doctor or nurse has shown you. Press the dose button to inject until the figure 0 in the display lines up with the pointer.

   As you do this, you may hear or feel a click.

   Leave the needle under the skin for at least 6 seconds to make sure that you get your full dose.

   You can let go of the dose button while you wait

I 6 seconds

1. J.

   Remove the needle from the skin.

   After that, you may see a drop of growth hormone at the needle tip. This is normal and has no effect on the dose you just received.

J

Never use the pen clicks to count the number of mg you inject. Only the display and pointer will indicate the exact number of mg.

Never touch the display when you inject, as this can block the injection.
K. Put the outer needle cap back on carefully without touching the needle. Unscrew the needle and throw it away carefully as instructed by your doctor or nurse. Put the pen cap back on after every use. When the pen is empty, throw it away without a needle on as advised by your doctor or nurse and local authorities.		K
		Never put the inner needle cap back on once you have removed it from the needle. You may accidentally stick yourself with the needle. Always store the pen without a needle attached. This reduces the risk of contamination, infection, leakage of growth hormone, blocked needles and inaccurate dosing.
Caring for your NORDITROPIN® FlexPro® pen Treat your NORDITROPIN® FlexPro® pen with care: Do not drop your pen or knock it against hard surfaces. If you do drop it or suspect that something is wrong with it, always screw on a new disposable needle and check the growth hormone flow before you inject. Do not try to refill your pen – it is pre-filled. Do not try to repair your pen or pull it apart. Do not expose your pen to dust, dirt, liquid or direct light. Do not try to wash, soak or lubricate your pen. If necessary, clean it with a mild detergent on a moistened cloth. Do not freeze your pen or store it close to any cooling element, e.g., in a refrigerator, store far away from the cooling elements. See the “Storage” section of this leaflet for information about how to store your pen.
			Important information Always keep your pen and needles out of reach of others, especially children. Never share your pen or your needles with other people. It might lead to cross-infection. Caregivers must be very careful when handling used needles – to reduce the risk of needle injury and cross-infection.
Important information Pay special attention to these notes as they are important for safe use of the pen. Additional information
NORDITROPIN® FlexPro® 5 mg / 1.5 mL Somatropin NORDITROPIN® FlexPro® 10 mg / 1.5 mL Somatropin NORDITROPIN® FlexPro® 15 mg / 1.5 mL Somatropin