What does Norditropin® do?
Norditropin® provides growth hormone for children who do not make enough 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.
What are hormones?
Hormones are chemicals that carry messages produced in one part of the body that travel to another part of the body to create some sort of change.
What is growth hormone?
Growth hormone is made in the pituitary gland, which is located at the base of the brain.
Pituitary gland
It makes and releases growth hormones which is very important for growth and health.
What is the dosing for Norditropin®?
Your or your child’s doctor will calculate the dose of Norditropin® most appropriate for you or your child, based on body weight.
What if I or my child misses a dose of Norditropin®?
If a dose of medication is missed, it may not work as well as it should. Talk to your doctor or child’s doctor if this happens. If you or your child misses a dose, it is not recommended to double the next dose. Administer the regular dose at the next scheduled dosage time.
What if too much Norditropin® is taken?
If you or your child has been given too much Norditropin®, speak to your or your child’s doctor, hospital emergency department or regional Poison Control Centre immediately, even if there are no 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.
What are some warnings that should be considered for me or my child?
Do not use Norditropin® if:
- You or your child has an illness that requires immediate intensive medical support due to 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.
- You or your child has closed epiphyses (growth areas of the bones have closed) and cannot grow any longer.
- You or your child has active cancer or other tumours. Cancer treatment must be finished before starting treatment with Norditropin®. Stop Norditropin® treatment if cancer develops.
- You or your 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.
- You or your child is allergic to any of the ingredients or to any component of the container in Norditropin®.
To help avoid side effects and ensure proper use, talk to your or your child’s doctor before taking Norditropin®.
Talk about any health conditions or problems you or your child may have, including if you or 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 you or your child is on insulin, the dose may need to be adjusted because Norditropin® may affect the body’s response to insulin.
- Is experiencing headaches, 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 you or your teenaged child becomes pregnant or is sexually active, talk to your or your child’s doctor as it is not known if Norditropin® could cause harm to an unborn baby, or whether it can pass into breast milk when breastfeeding.
Are there other warnings and precautions I or my child should consider before taking Norditropin®?
- 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 injected.
- Patients should be advised to talk to their doctor 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 or your child’s doctor will need to monitor for a return of cancer or a tumour. Talk to your or your child’s doctor if you or 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 or your child’s doctor will do blood tests to check your or your child’s thyroid hormone levels.
- Norditropin® may cause a decrease in a hormone called cortisol.
- Tell your or your child’s doctor if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss. The healthcare professional will do blood tests to check your or your child’s cortisol levels.
- Norditropin® may cause an increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your or your child’s blood.
- Your or your child’s doctor will do blood tests to check this.
What are some side effects of using Norditropin®?
| Side Effect | What to do |
|---|---|
| Serious allergic reactions | Get medical help immediately if you or 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 at the injection site | If this appears to be particularly troublesome or if the injection area becomes painful, discuss this with your or your child's doctor. |
| Insulin resistance | Insulin resistance means your or your child's body cannot make good use of the insulin it produces. This causes higher levels of glucose in the blood. It is important to check your or your child's blood glucose levels if you or your child has diabetes or a family history of diabetes. |
| Nausea, vomiting, headache or visual changes | If you or your child experiences any of these side effects notify your or your child's doctor. |
| Breathing problems in patients with Prader-Willi syndrome | If you or your child has Prader-Willi syndrome and develops signs of breathing problems, sleep apnea (not breathing while sleeping) or new or increased snoring, speak to your or your child's doctor. |
| Unexplained limp, or complains of hip/knee pain (slipped capital femoral epiphysis) | Contact your or your child's doctor. |
| Middle ear infection, hearing problems or ear problems in children with Turner syndrome | If you or your child experiences any of these side effects notify your or your child's doctor. |
| Fluid retention with swelling of the hands and feet at the initiation of treatment, or mild joint pain, muscle pain and tingling or numbness of the hands and feet may occur | Will usually improve without treatment. |
| Breast enlargement (gynecomastia) | N/A |
| Inflammation of the pancreas (in rare cases), which causes severe pain in the abdomen and back | Contact your or your child's doctor if you or your child develops severe stomach-ache after taking Norditropin®. |
These are not all the possible side effects you or your child may feel when taking Norditropin®. If you or your child experience any side effects not listed here, contact your or your child’s doctor.
What are some serious side effects of using Norditropin®?
| Symptom/effect | Talk to your's or your child's healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Very Common | |||
| Respiratory tract infections: Cough; sneezing; nasal congestion; runny nose; fever; scratchy or sore throat. | √ | ||
| Ear infections: Ear pain; fever; drainage from the ear that is thick and yellow or bloody; loss of appetite, vomiting, and grumpy behavior; trouble sleeping. | √ | ||
| Skin infections: Redness of the skin and a rash; itching, pain, and tenderness. | √ | ||
| Infection in the small intestine: Gas, bloating, diarrhea, abdominal pain or cramping; constipation. | √ | ||
| Common | |||
| Worsening of curvature of the spine (scoliosis): Back pain; one shoulder blade is higher than the other; one shoulder blade sticks out more than the other; uneven hips. | √ | ||
| Pain in the joints | √ | ||
| Asthma: Shortness of breath; chest tightness or pain; coughing or wheezing. | √ | √ | |
| Swelling of adenoid glands: Blocked, stuffy nose; ear problems; problems sleeping; sore throat; difficulty swallowing; swollen glands in the neck. | √ | ||
| Constipation: Passing fewer than three stools a week; having hard stools; straining to have a bowel movement; feeling as though you can't completely empty the stool from your rectum. | √ | ||
| Sleep Apnea: Silent pauses in breathing; choking or gasping sounds while sleeping; daytime sleepiness or fatigue. | √ | √ | |
| Uncommon | |||
| Heart problems: Difficulty breathing; shortness of breath, chest pain, or tightness; feeling of heavy, pounding, or noticeable heartbeats; fainting. | √ | √ | |
| Jaundice: Yellowing of the skin or eyes. | √ | ||
| Convulsions: Losing consciousness; having uncontrollable muscle spasms; drooling or frothing at the mouth, having a strange taste in your mouth; clenching your teeth; biting your tongue; having sudden, rapid eye movements. | √ | √ | |
| Febrile convulsions: Breathing difficulty; contraction of the muscles of the face, limbs, and trunk; fever. | √ | √ | |
| Depression; aggression | √ | ||
If you or your child has a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with daily activities, talk to your or your child’s doctor.
What do I need to get myself or my child started with Norditropin®?
To get started with Norditropin®, you or your child will need to get familiar with the Norditropin® FlexPro® pen and understand how to use it.
Find out about how to get started on Norditropin®
How should I or my child store Norditropin®?
You or your child will need to know how to store Norditropin® properly before and after first use.
Find out about how to store Norditropin®
If you or your child still have questions and can’t find the answers on this website, be sure to ask your or your child’s doctor.