What is Norditropin, prefilled pen injection and what is it used for?
Therapeutic class: Somatropin and Somatropin Agonists
Norditropin HGH pens contain the human growth hormone analog somatropin, which is identical to the growth hormone naturally produced by the human body. Children need the growth hormone to promote their growth, but adults also need it for their general health.
In children, Norditropin is used to treat growth disorders:
- related to the lack or very low production of growth hormone (growth hormone deficiency)
- related to Turner syndrome (a genetic problem that can affect growth)
- related to reduced renal function
- in small children and those born small for gestational age (SGA)
In adults, Norditropin is used as a growth hormone replacement when its production has been reduced from childhood or stopped in adulthood due to a tumor, tumor treatment, or pituitary gland disease. If treated for HGH deficiency in your childhood, the persistence of this deficiency will be reassessed when growth is complete. If the growth hormone deficiency is confirmed, further treatment is necessary. Somatropin can also be prescribed to those experiencing wasting caused by HIV.
What information do you need to know before using Norditropin
Never use Norditropin prefilled pen injections:
- If you are allergic to somatropin, phenol or any of the other ingredients in this medicine
- If you have had a kidney transplant
- If you have an active tumor (cancer). Tumors must be inactive and you must have finished cancer treatment
- If you suffer from an acute critical condition, such as open-heart surgery, abdominal surgery, multiple accidental trauma or severe respiratory failure
- If you stopped growing (fused growth plates) and there is no growth hormone deficiency
Warnings and precautions
Talk to your doctor or pharmacist before using Norditropin:
- If you have diabetes
- If you’ve ever had cancer or any other form of tumors
- If you have recurrent headaches, vision problems, nausea, or vomiting
- If you have abnormal thyroid function
- If you start to limp or have back pain, this may be symptomatic of a spinal abnormality (scoliosis)
- If you are over 60 years of age or have received somatropin treatment as an adult for more than 5 years you need to get re-evaluated periodically by a knowledgeable endocrinologist
- If you have kidney disease, your kidney function should be monitored by your doctor
Tell your doctor or pharmacist if you are using or have recently used any of the following medications:
- Glucocorticoids or sex steroids (e.g., anabolic steroids and estrogens) because your adult size may be affected if you take somatropin and glucocorticoids or sex steroids at the same time
- Cyclosporin (immunosuppressant), as its dose may need adjusting
- Insulin, as your dose may need to be adjusted
- Thyroid hormones, since the doses may need adjusting
- Gonadotropins (gonad stimulating hormone), as its dose may need adjusting
- Anti-convulsants, since their dose may need adjusting
Pregnancy and breastfeeding
Products containing somatropin are not recommended for women of childbearing age who do not use contraception.
- Pregnancy: If you become pregnant while taking Norditropin, stop taking it, and tell your doctor.
- Breastfeeding: Do not use Norditropin if you are breastfeeding as somatropin may pass into breast milk.
Driving and using machinery
Norditropin has no effect on the ability to drive vehicles and operate machinery.
How to use Norditropin Pen
Always use this medicine exactly as directed by your physician. Consult your doctor or pharmacist if you are unsure.
In children, the dose depends on weight and body surface area. After childhood, the dose depends on height, weight, sex, and sensitivity to growth hormone and is adjusted until the optimal dose is reached.
- Children born small for gestational age: The usual dose is 0.035 mg per kg per day or 1.0 mg per m² of body surface per day until the final height is reached (in clinical studies, children of gestational age were treated with doses between 0.033 and 0.067 mg per kg per day).
- Children with little or no growth hormone production: The usual dose is 0.025 to 0.035 mg per kg per day or 0.7 to 1.0 mg per m² of body surface per day.
- Children with Turner syndrome: The usual dose is 0.045 to 0.067 mg per kg per day or 1.3 to 2.0 mg per m² of body surface per day.
- Children with chronic renal insufficiency: The usual dose is 0.050 mg per kg per day or 1.4 mg per m² of body surface area per day.
- Adults with low or no growth hormone production: If their growth hormone deficiency persists after growth is complete, treatment should be continued. The usual starting dose is 0.2 to 0.5 mg per day. The dose is adjusted until the optimal dose is reached. If your growth hormone deficiency begins in adulthood, the usual starting dose is 0.1 to 0.3 mg per day. Your doctor will increase this dose every month until the correct dose is reached. The usual maximum dose is 1.0 mg per day.
When using Norditropin 5 mg/1.5 mL, prefilled pen injection solution
Inject your daily dose under the skin every evening just before bedtime.
How to use Norditropin pen?
- Check the solution before use by turning the pen up and down once or twice. Do not use the pen if the solution inside is opaque or colored.
- Norditropin is intended for use with NovoFine or NovoTwist disposable needles up to 8 mm in length.
- A new needle is always inserted for each injection.
- Change the injection site to avoid damaging your skin.
- To ensure correct dosing and to avoid air injection, check the flow (i.e. pen bleeding) of growth hormone before the first injection. Do not use the pen if no drops of growth hormone solution appear on the needle tip.
Do not share on your Norditropin pen with other people.
How long will your treatment last?
- Small children with a growth disorder associated with Turner syndrome, chronic renal failure, or SGA: Your doctor will recommend that you continue treatment until growth stops.
- Children or adolescents with growth hormone deficiency: Your doctor will recommend that you continue treatment as an adult.
- Do not stop using Norditropin without first consulting your doctor.
If you have accidentally used more Norditropin than you needed Consult your doctor or pharmacist immediately!
If you have injected too much somatropin, talk to your doctor. Prolonged somatropin overdose may cause abnormal growth and thickening of the facial features (Acromegaly).
If you forgot to use Norditropin:
Take the next usual dose at the usual time. Do not take a double dose to make up for the lost dose.
When discontinuing Norditropin injections do not stop taking Norditropin without first consulting your doctor.
If you have further questions about the use of this medicine, ask your doctor or pharmacist for more information.
What are the possible side effects of Norditropin?
Like all medicines, this medicine may have side effects. However, these side effects do not always occur in everyone.
Adverse reactions in children and adults (frequency not known) :
- Rash, wheezing, and swelling of the eyelids. Any of these signs may be a sign of allergic reactions.
- Headache, blurred vision, nausea, and vomiting. This could be a sign of increased pressure on the brain.
- Serum thyroxine levels can decrease.
- Hyperglycemia (high blood sugar).
If you experience any of these effects, consult a doctor as soon as possible. Stop taking Norditropin until your doctor tells you to start taking it again.
The formation of antibodies that act directly against somatropin has rarely been observed during treatment with Norditropin.
High concentrations of liver enzymes have been reported.
Leukemia and recurrent brain tumors have also been reported in patients treated with somatropin (the active ingredient of Norditropin), although there is no evidence that somatropin is the cause.
If you think you have any of these conditions, talk to your doctor.
Additional side effects in children:
Unusual (may affect up to 1 in 100 children):
- Redness, itching, and pain at the injection site
Rare (may affect up to 1 in 1,000 children):
- Muscle pain
- Joint pain
- Swelling of the hands and feet from water retention.
Rare cases of hip and knee pain and limping have been reported in children taking Norditropin. These symptoms may be related to a disorder of the femur (Legg-Calve-Perthes disease) or slippage of the tip of the femur in relation to the cartilage (epiphysiolysis of the femoral head) and may not be due to Norditropin.
In children with Turner syndrome, clinical studies have observed some cases of increased growth of hands and feet in relation to height.
A clinical study in children with Turner syndrome showed that high doses of Norditropin may increase the risk of ear infections.
If any of these side effects affect you significantly, or if you notice any side effects not listed in this guide, you should talk to your doctor or pharmacist as the dose may be reduced.
Additional adverse reactions in adults
Very common (may affect more than 1 in 10 adults):
- Hand and foot swelling due to water retention.
- Tingling in the skin and numbness or pain mainly in the fingers,
- Joint pain and stiffness, muscle pain.
Unusual (may affect up to 1 in 100 adults):
- Type 2 diabetes,
- Carpal tunnel syndrome with tingling and pain in the fingers and hands
- Itching (which can be serious) and pain at the injection site
- Muscle stiffness
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this article. You can also report adverse reactions directly to the FDA.
By reporting adverse reactions, it helps to provide more information on the safety of the medicine.
HOW to store Norditropin 15 mg/1.5 ml, prefilled pens?
Keep the medicine out of sight and out of the reach of children.
Do not use this medicine after the expiry date shown on the container.
Store unused Norditropin in a refrigerator (between 2°C and 8°C) away from light. Do not freeze or expose to heat.
After starting to use Norditropin store the opened pen in a refrigerator (between 2°C and 8°C) for up to 4 weeks or store at room temperature (not above 25°C) for up to 3 weeks
Do not continue to use a Norditropin pen that has been frozen or exposed to excessive temperatures.
Do not use Norditropin Pen if the growth hormone solution inside is opaque or discolored.
Always store Norditropin without a needle.
Always keep the cap of the Norditropin Pen closed when not in use.
Always use a new needle for each injection.
Do not dispose of drugs in the sewerage system or with household waste. Ask your pharmacist to dispose of medicines that you no longer use. This will help to protect the environment.
Read Also: Growing Taller as an Adult: Is It Possible?
Norditropin pen Ingredients
- The active ingredient is somatropin.
- The other ingredients are as follows mannitol, poloxamer 188, phenol, water for injection, histidine, hydrochloric acid, and sodium hydroxide.
Norditropin is presented as a clear, colorless injectable HGH solution in a pre-filled 1.5 mL multi-dose disposable pen.
- 1 mL of the solution contains 10 mg somatropin.
- 1 mg somatropin corresponds to 3 IU somatropin.
Norditropin is available in three strengths:
5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL (3.3 mg/mL, 6.7 mg/mL and 10 mg/mL respectively).