Norditropin® SimpleXx® 10 mg/1.5 ml solution for injection in cartridge
1. What Norditropin® SimpleXx® is and what it is used for
Norditropin® SimpleXx® 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® 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® 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® 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®
Do not use Norditropin® SimpleXx®
- 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 your doctor or pharmacist before using Norditropin® SimpleXx®
- 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 this 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® 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® while you are breast-feeding as somatropin might pass into your milk.
Driving and using machines
Norditropin® SimpleXx® does not affect the use of any machines or the ability to drive safely.
3. How to use Norditropin® SimpleXx®
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 0.050 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 should be continued. The usual starting dose is 0.2 to 0.5 mg per day. Dose will be adjusted until you are on the right dose. If your growth hormone deficiency starts during adult life, the usual starting dose is 0.1 to 0.3 mg per day. Your doctor will increase this dose each month until you are on the right dose. The usual maximum dose is 1.0 mg per day.
When to use Norditropin® SimpleXx®
Inject your daily dose into the skin every evening just before bedtime.
How to use Norditropin® SimpleXx®
- Norditropin® SimpleXx® 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® 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.