Norditropin Simplex

Indications

Somatropin is man-made human growth hormone. In children it is used to treat poor growth caused by growth hormone deficiency, and growth problems linked to Turner syndrome, Prader-Willi syndrome, Noonan syndrome, chronic kidney disease, SHOX gene deficiency, or being born small for gestational age without catching up. In adults it is used to replace growth hormone when the pituitary gland does not make enough.

How It Works

Somatropin has the same structure as the growth hormone made by the pituitary gland. It stimulates the liver and other tissues to produce IGF-1, a substance that drives growth of bones and muscles. It also affects how the body handles fat, protein and sugar, helping to build muscle and reduce body fat in adults with deficiency.

Dosage and Administration

Somatropin is given as an injection under the skin, usually once a day in the evening. The dose is calculated by a specialist from body weight or body surface area and adjusted according to growth, blood tests and response, so it must be used exactly as prescribed. Patients or parents are trained to give the injection with a pen or syringe. Change the injection site each time (thigh, abdomen, buttock or upper arm) to avoid skin changes.

Interactions

Corticosteroids such as Prednisolone or Hydrocortisone can reduce its growth effect. Somatropin can raise blood sugar, so doses of Insulin and other diabetes medicines may need adjusting. Women taking oral oestrogen may need a higher dose. It may change the effect of thyroid hormone and of some medicines broken down by the liver, such as Ciclosporin and some antiepileptics. Tell your doctor about all your medicines.

Contraindications

Somatropin must not be used:

• If there is any active tumour or cancer
• To promote growth in children whose bone growth plates have closed
• In people who are acutely and critically ill after major surgery, serious injury or breathing failure
• In people with Prader-Willi syndrome who are severely overweight or have severe breathing problems or sleep apnoea
• With active proliferative diabetic eye disease, or allergy to the medicine

Side Effects

Common side effects include:

• Pain, redness or swelling at the injection site
• Headache
• Joint or muscle pain, and swelling of hands or feet from fluid retention
• Tingling or numbness in the hands (carpal tunnel symptoms)
• Raised blood sugar or reduced thyroid hormone levels

Get urgent medical help for a severe headache with vision changes, nausea or vomiting; a new limp or hip or knee pain in a child; severe stomach pain; or swelling of the face or throat or difficulty breathing.

Pregnancy and Lactation

Treatment is usually stopped if pregnancy occurs, as there is little information on its safety. It is not known whether Somatropin passes into breast milk. Talk to your specialist before planning a pregnancy or breastfeeding.

Precautions and Warnings

Your doctor will check growth, blood sugar, thyroid function and IGF-1 levels regularly. Children with growth hormone deficiency caused by a previous tumour need checks for regrowth. Curvature of the spine (scoliosis) can worsen during fast growth. People with diabetes need closer sugar monitoring. Never share pens or needles.

Overdose

A large single overdose may first cause low blood sugar and then high blood sugar. Long-term overdose can lead to signs of too much growth hormone, such as enlarged hands, feet and facial features. Contact your doctor if you inject more than prescribed.

Therapeutic Class

Growth hormone (pituitary hormone, recombinant somatotropin).

Storage

Store in a refrigerator at 2 to 8°C. Do not freeze. Keep in the original carton to protect from light, out of the reach of children. Once in use, follow the storage time stated on the leaflet.