Norditropin Simplexx: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication 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 also used for the treatment of children with short stature born small for gestational age (SGA) with no catch-up growth by age 2.

What it does:

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.

When it should not be used:

• If the child has acute critical illness due to complications following open heart surgery, abdominal surgery, multiple trauma, or acute respiratory failure.
• If the child’s growth areas of the bones have closed (closed epiphyses) and cannot grow any longer.
• If the child has active cancer or tumours. Tumours must be inactive and anti-tumour treatment must be finished before starting treatment with Norditropin^®. Therapy with Norditropin^® should be discontinued if evidence of cancer develops.

• Norditropin^® is not to be used for long-term treatment of growth failure due to genetically confirmed 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.
  • If the child is hypersensitive to this drug or to any ingredient in the formulation or component of the container.

What the medicinal ingredient is:

Somatropin (recombinant human growth hormone)

What the nonmedicinal ingredients are:

histidine, mannitol, phenol, poloxamer 188 and water for injections

What dosage forms it comes in:

Norditropin^® SimpleXx^® is available as a cartridge in 3 strengths (5 mg/1.5 mL; 10 mg/1.5 mL and 15 mg/1.5 mL) for use with the NordiPen^® delivery system.

Norditropin NordiFlex^® 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

WARNINGS AND PRECAUTIONS

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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 hormone deficiency.

BEFORE using Norditropin^® talk to your doctor or pharmacist if:

• The child has Prader-Willi syndrome and breathing problems, sleep apnea (not breathing while sleeping), snoring or a respiratory infection.
• The child 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.
• The child is experiencing headache, nausea, visual changes and/or vomiting. These are symptoms of a condition called intracranial hypertension.
• The child has a history of lesions or tumour of the brain.
• The child has a history of hypothyroidism (low levels of thyroid hormone), since Norditropin^® may reduce the levels of thyroid hormone in the body.
• The child has a history of scoliosis (a condition which affects the spine). Since growth hormone increases
• growth rate, patients with a history of scoliosis who are treated with Norditropin^® should be monitored for progression of scoliosis.

If the child develops any of these symptoms during treatment with Norditropin^® please speak with your doctor immediately.

This information will help your doctor and you decide whether you should use Norditropin^® and what extra care may need to be taken while your child is on the medication.

INTERACTIONS WITH THIS MEDICATION

Norditropin^® is generally safe to take with other medicines. You should, however, tell the doctor about all medicines that the child is taking, including those obtained without a doctor’s prescription.

Corticosteroids (steroids) may decrease the effects of Norditropin^®. If the child is currently receiving concomitant steroid therapy talk to your doctor. Doses of the steroid may need to be adjusted.

Norditropin^® may also affect the body’s response to insulin. Tell your doctor if your child is currently taking insulin. Your child’s insulin dose may need to be adjusted.

PROPER USE OF THIS MEDICATION

Your doctor has prescribed Norditropin^® after carefully studying your child’s case. Other people may not benefit from taking this medicine, even though their problems may seem similar to yours.

Usual dose:

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

Overdose:

Call your doctor immediately if your child takes more than the amount of Norditropin^® prescribed by the doctor.

Missed Dose:

Missing doses can interfere with the effectiveness of the medication. Talk to the child’s doctor if this happens. If you miss 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.

If your child is taking Norditropin NordiFlex^® please see the section “INFORMATION ON HOW TO INJECT NORDITROPIN NORDIFLEX^®”at the end of this leaflet.

If your child is taking Norditropin^® SimpleXx^® please refer to the separate user guide provided in the package containing NordiPen^®.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Unwanted effects are possible with all medicines. Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are receiving treatment with Norditropin^®.

The following side effects may occur while using Norditropin^®:

• 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 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.
• If the child shows an unexplained limp, or complaints of hip/knee pain, please contact your child’s doctor.

This is not a complete list of side effects. For any unexpected effects while taking Norditropin^®, contact your doctor.

REPORTING SUSPECTED SIDE EFFECTS

HOW TO STORE NORDITROPIN^®

Storage Options

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.novonordisk.ca or by contacting Novo Nordisk Canada Inc., at: 1-800-465-4334

Last revised: January 2015

Norditropin^® SimpleXx^®, Norditropin NordiFlex^®, NordiPen^®, NovoFine^® and NovoTwist^® are registered trademarks of Novo Nordisk A/S and Novo Nordisk Health Care AG and are used under license by Novo Nordisk Canada Inc.

© Novo Nordisk Canada Inc. 2015

MORE INFORMATION

Introduction Norditropin NordiFlex® is a multi-dose pre-filled pen with human growth hormone solution for injection. The dose is in milligrams (mg). Your health care professional will provide the correct dose for you. For Norditropin NordiFlex® 5 mg/1.5 mL, you can use the dose selector to dial any dose from 0.025 to 1.50 mg. For Norditropin NordiFlex® 10 mg/1.5 mL, you can use the dose selector to dial any dose from 0.05 to 3.00 mg. For Norditropin NordiFlex® 15 mg/1.5 mL, you can use the dose selector to dial any dose from 0.075 to 4.50 mg. Norditropin NordiFlex® is designed to be used with NovoFine®, NovoFine® Plus or NovoTwist® disposable needles up to a length of 8 mm. The Norditropin NordiFlex® pen should not be shared with anyone else. Prior to any contact with Norditropin NordiFlex® wash hands thoroughly with soap and water. Norditropin NordiFlex® should not be shaken vigorously at any time. Please read the following instructions carefully before using Norditropin NordiFlex®.	Residual scale Inner needle cap Protective paper tab Pen cap Cartridge Dosage selector Dosage indicator window Push button Residual scale window Disposable needle (example) Outer needle cap Needle
1. Check the solution Pull off the pen cap [A]. Check the solution inside the pen by turning it upside down once or twice. Only use the Norditropin NordiFlex® pen if the solution inside is clear and colourless.
2. Attach the needle Always use a new disposable needle for each injection in order to receive the correct dose and prevent contamination. Take a new needle and remove the protective paper tab. Screw the needle tightly onto the injection pen [B]. The needle has two needle caps. You need to remove them both. Pull off the outer needle cap and keep it to dispose of the used needle later.

Remove the inner needle cap by pulling on the central tip and throw it away.
3. Check the flow Before you use a new pen for the first time, you need to check the flow (called ‘priming’ the pen) to make sure you get the correct dose and do not inject any air [C]. For Norditropin NordiFlex® 5 mg/1.5 mL dial 0.025 mg. This is one ‘click’ after 0.0 on the dose selector at the end of the pen. For Norditropin NordiFlex® 10 mg/1.5 mL dial 0.05 mg. This is one ‘click’ after 0.0 on the dose selector at the end of the pen. For Norditropin NordiFlex® 15 mg/1.5 mL dial 0.075 mg. This is one ‘click’ after 0.0 on the dose selector at the end of the pen.	C
Hold Norditropin NordiFlex® with the needle pointing upwards and tap the cartridge gently with your finger a few times [D].
Holding the Norditropin NordiFlex® pen with the needle upwards, press the push button at the bottom of the pen all the way in [E]. Repeat steps C to E until a drop of growth hormone solution appears at the needle tip. Do not use the Norditropin NordiFlex® pen if a drop of growth hormone solution does not appear. Always check the flow (prime the pen) before the first injection from a new Norditropin NordiFlex® pen. Check the flow again if your pen has been dropped or knocked against a hard surface or if you are not sure that Norditropin NordiFlex® works properly.
4. Dial the dose Check that the dosage selector is set at 0.0. Dial the number of mg your doctor has recommended for you [F]. The dose can be increased or decreased by turning the dosage selector in either direction. When dialing back, be careful not to press the push button as growth hormone will come out. You cannot set a dose larger than the amount of solution left in the pen.
5. Inject the solution

Use the injection technique recommended to you. Your doctor or nurse will teach you how to locate appropriate injection sites. It is very important that you rotate the site of an injection each time you give the medication. Prepare the injection site by wiping with an alcohol swab. Insert the needle into your skin. Deliver the dose by pressing the push button all the way in. Be careful only to press the push button when injecting [G]. After the injection, keep the needle under the skin for at least 6 seconds and then withdraw it. Keep the push button fully depressed until the needle is withdrawn from the skin. This ensures that you get the full dose.
6. Remove the needle Replace the outer needle cap and unscrew the needle [H]. Dispose of it carefully. Always use a new needle for each injection and always remove a used needle immediately after the injection. If you do not remove the needle immediately, air may enter into the cartridge, which may mean you get the wrong dose next time. Caregivers should be most careful when handling used needles to avoid needle sticks. When the Norditropin NordiFlex® pen is empty, dispose of it carefully without the needle attached. Ask your health care professional how to dispose of used needles and empty Norditropin NordiFlex® pens.	H
7. Maintenance Look after your Norditropin NordiFlex® pen so that it continues to work accurately and safely. Norditropin NordiFlex® should be handled with care. Avoid situations where Norditropin NordiFlex® might be damaged. Protect Norditropin NordiFlex® from dust, dirt and direct sunlight. You can clean the exterior of your Norditropin NordiFlex® by wiping it with cotton wool moistened with alcohol. Do not soak Norditropin NordiFlex® in alcohol, wash, or lubricate it as this may damage it.