Norditropin Simplexx Pen 45IU contains a biosynthetic human growth hormone called somatropin which is identical to the growth hormone produced naturally in the body. Children need growth hormone to help them grow, but adults also need it for their general health.
Norditropin Simplexx Pen 45IU comes as a solution in a cartridge ready for you to inject after you have put it in the matching NordiPen injection pen.
Norditropin Simplexx Pen 45IU is used to treat growth failure in children:
If they have no or very low production of growth hormone (growth hormone deficiency)
If they have Turner syndrome (a genetic problem which may affect growth)
If they have reduced kidney function
If they are short and were born small for gestational age (SGA).
Norditropin SimpleXx is used as a growth hormone replacement in adults:
In adults Norditropin Simplexx Pen 45IU is used to replace growth hormone if their growth hormone production has been decreased since childhood or has been lost in adulthood because of a tumour, treatment of a tumour, or a disease that affects the gland which produces growth hormone. If you have been treated for growth hormone deficiency during childhood, you will be retested after completion of growth. If growth hormone deficiency is confirmed, you should continue treatment.
2. What you need to know before you use Norditropin Simplexx Pen 45IU
Do not use Norditropin Simplexx Pen 45IU
If you are allergic to somatropin, to phenol, or to any of the other ingredients of this medicine (listed in section 6)
If you have had a kidney transplant
If you have an active tumour (cancer). Tumours must be inactive and you must have finished your anti-tumour treatment before you start your treatment with Norditropin SimpleXx
If you have an acute critical illness e.g. open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure
If you have stopped growing (closed epiphyses) and you do not have growth hormone deficiency.
Warnings and precautions
Talk to you doctor or pharmacist before using Norditropin Simplexx Pen 45IU
If you have diabetes
If you have ever had a cancer or another kind of tumour
If you have recurrent headaches, eyesight problems, nausea, or if vomiting occurs
If you have abnormal thyroid function
If you develop a limp or low-back pain as these could be signs of a curved spine (scoliosis)
If you are over 60 years of age, or have received somatropin treatment as an adult for more than 5 years, as experience is limited
If you suffer from kidney disease as your kidney function should be monitored by your physician.
Other medicines and Norditropin SimpleXx
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines
Glucocorticoids or sex steroids (for example anabolic steroids and estrogen) – your adult height may be affected if you use Norditropin Simplexx Pen 45IU and glucocorticoids or sex steroids at the same time
Cyclosporin (immunosuppressive) – as your dose may need to be adjusted
Insulin – as your dose may need to be adjusted
Thyroid hormone – as your dose may need to be adjusted
Gonadotrophin (gonad stimulating hormone) – as your dose may need to be adjusted
Anticonvulsants – as your dose may need to be adjusted.
Pregnancy and breast-feeding
Somatropin containing products are not recommended in women of childbearing potential not using contraception.
Pregnancy. Stop the treatment and tell your doctor if you become pregnant while you are using Norditropin Simplexx
Breast-feeding. Do not use Norditropin Simplexx Pen 45IU while you are breast-feeding as somatropin might pass into your milk.
Driving and using machines
Norditropin does not affect the use of any machines or the ability to drive safely.
3. How to use Norditropin
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The dose for children depends on their body weight and body surface area. Later in life, the dose depends on height, weight, gender and growth hormone sensitivity and will be adjusted until you are on the right dose.
Children with low production or lack of growth hormone: The usual dose is 0.025 to 0.035 mg per kg body weight per day or 0.7 to 1.0 mg per m2 body surface area per day
Children with Turner syndrome: The usual dose is 0.045 to 0.067 mg per kg body weight per day or 1.3 to 2.0 mg per m2 body surface area per day
Children with kidney disease: The usual dose is 0.05 mg per kg body weight per day or 1.4 mg per m2 body surface area per day
Children born small for gestational age (SGA): The usual dose is 0.035 mg per kg body weight per day or 1.0 mg per m2 body surface area per day until final height is reached. (In clinical trials of short children born SGA doses of 0.033 and 0.067 mg per kg body weight per day have typically been used)
Adults with low production or lack of growth hormone: If your growth hormone deficiency continues after completion of growth, treatment shoul
When to use Norditropin Simplexx
Inject your daily dose into the skin every evening just before bedtime.
How to use Norditropin Simplexx
Norditropin Simplexx Pen 45IU solution comes in cartridges with a color coded cap and is ready to be used in the matching color coded NordiPen. If the corresponding NordiPen is not used it will result in incorrect dosing. The NordiPen instruction manual tells you how to use the cartridges in the injection pen
Check each new Norditropin Simplexx Pen 45IU cartridge before you use it. Do not use any cartridge that is damaged or cracked
Do not use the Norditropin SimpleXx cartridges if the solution inside is cloudy or discoloured
Vary the area you inject so you do not harm your skin
Do not share your Norditropin SimpleXx cartridge with anyone else.
How long you will need treatment for
Children with growth failure because of Turner syndrome, kidney disease, or SGA: Your doctor will recommend you continue treatment until you stop growing
Children or adolescents who lack growth hormone: Your doctor will recommend you continue treatment into adulthood
Do not stop using Norditropin SimpleXx without discussing it with your doctor first.
If you use more Norditropin Simplexx Pen 45IU than you should:
Tell your doctor if you inject too much somatropin. Long-term overdosing can cause abnormal growth and coarsening of facial features.
If you forget to use Norditropin Simplexx Pen 45IU:
Take the next dose as usual, at the normal time. Do not take a double dose to make up for a forgotten dose.
If you stop using Norditropin Simplexx
Do not stop using Norditropin Simplexx Pen 45IU without discussing it with your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Effects seen in children and adults (unknown frequency):
Rash; wheezing; swollen eyelids, face or lips; complete collapse. Any of these may be signs of allergic reactions
Headache, eyesight problems, feeling sick (nausea), and being sick (vomiting). These may be signs of raised pressure in the brain
Serum thyroxin levels may decrease
Hyperglycaemia (elevated levels of blood glucose).
If you get any of these effects, see a doctor as soon as possible. Stop using Norditropin® SimpleXx® until your doctor says you can continue treatment.
Formation of antibodies directed against somatropin has been rarely observed during Norditropin® therapy.
Increased levels of liver enzymes have been reported.
Cases of leukaemia and relapse of brain tumours have also been reported in patients treated with somatropin (the active ingredient in Norditropin Simplexx Pen 45IU), although there is no evidence that somatropin was responsible.
If you think you are suffering from any of these diseases, speak to your doctor.
Additional side effects in children:
Uncommon (may affect up to 1 in 100 children):
Redness, itching, and pain in the area of injection.
Rare (may affect up to 1 in 1,000 children):
Muscle and joint pain
Swollen hands and feet due to fluid retention.
In rare cases, children using Norditropin SimpleXx have experienced hip and knee pain or have started limping. These symptoms may be caused by a disease affecting the top of the thigh bone (Legg-Calvé disease) or because the end of the bone has slipped from the cartilage (slipped capital femoral epiphysis) and may not be due to Norditropin Simplexx Pen 45IU.
In children with Turner syndrome, a few cases of increased growth of hands and feet compared to height have been observed in clinical trials.
A clinical trial in children with Turner syndrome has shown that high doses of Norditropin® can possibly increase the risk of getting ear infections.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist, as the dose may need to be reduced.
Additional side effects in adults:
Very common (may affect more than 1 in 10 adults):
Swollen hands and feet due to fluid retention.
Common (may affect up to 1 in 10 adults):
Feeling of skin crawling (formication) and numbness or pain mainly in fingers
Joint pain and stiffness; muscle pain.
Uncommon (may affect up to 1 in 100 adults):
Type 2 diabetes
Carpal tunnel syndrome; tingling and pain in fingers and hands
Itching (can be intense) and pain in the area of injection
Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Norditropin Simplexx Pen 45IU
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after EXP/. The expiry date refers to the last day of that month.
Store unused Norditropin SimpleXx cartridges in a refrigerator (2°C – 8°C) in the outer carton, in order to protect from light. Do not freeze or expose to heat.