What is NutropinAq?
NutropinAq is a solution for injection contained in a cartridge. Each cartridge contains 10 mg (corresponding to 30 IU) of the active ingredient somatropin.
What is NutropinAq used for?
NutropinAq is used to treat children in the following cases:
• children with growth failure due to insufficient growth hormone;
• children whose short stature is attributable to Turner syndrome (a rare genetic problem affecting girls), confirmed by chromosomal analysis (DNA test);
• prepubertal children with growth failure associated with chronic renal failure up to the time of kidney transplant.
NutropinAq is used to treat adults in the following cases:
• adult patients with growth hormone deficiency (replacement therapy) - the deficiency may have originated in adulthood or childhood and must be ascertained before treatment.
The medicine can only be obtained with a prescription.
How is NutropinAq used?
NutropinAq treatment should be started and supervised by a physician experienced in the treatment of patients with growth disorders. The medicine is given once a day by subcutaneous injection (under the skin) using a pen specially designed for the NutropinAq cartridge. NutropinAq can be injected directly by the patient or caregiver, after receiving adequate instruction from a doctor or nurse. The injection site must be changed daily. The doctor calculates the dose for the individual patient according to his condition; this dose may need to be corrected over time based on response, age and body weight.
How does NutropinAq work?
Growth hormone is a substance secreted by the pituitary gland (a gland located at the base of the brain). This substance stimulates growth during childhood and adolescence, also affecting the way the body uses proteins. fats and carbohydrates. The active ingredient in NutropinAq, somatropin, is analogous to human growth hormone. It is produced by a method known as 'recombinant DNA technology': this hormone is made by starting a bacterium that has received a gene (DNA) that allows it to produce it. NutropinAq replaces the natural hormone.
How has NutropinAq been studied?
NutropinAq has been studied in children with growth failure due to growth hormone deficiency, Turner syndrome or kidney disease. NutropinAq has also been studied in 171 adult patients with growth hormone deficiency. These studies were controlled (NutropinAq was compared with placebo (a dummy treatment) or with a group of untreated patients), with the exception of studies in children with "growth hormone deficiency for which there was no" comparison with another group. The main measurements made in these studies in children were height at the end of the study and the rate of growth during the study. The main measurements made in the studies in adult patients were lean body mass and total body fat loss.
What benefit has NutropinAq shown during the studies?
NutropinAq generated significantly better growth in children than expected without treatment. In adults, NutropinAq increased lean body mass and reduced total body fat.
What is the risk associated with NutropinAq?
The most common side effects in adults are myalgia (muscle pain), arthralgia (joint pain) and edema (swelling), which occur in more than 1 in 10 patients. In children, the frequency is lower (between 1 and 10 in 100 patients). Other side effects found in this low frequency range are injection site reaction, headache, hypertonia (muscle tension), hypothyroidism (reduced activity of the thyroid gland), asthenia (weakness) and development of antibodies (proteins that are produced in response to NutropinAq). For the full list of side effects reported with NutropinAq, see the package leaflet.
NutropinAq must not be used in people who are hypersensitive (allergic) to somatropin or any of the other substances. NutropinAq should not be used in the presence of an active tumor or life-threatening disease. NutropinAq should not be used to stimulate the growth of children with fused epiphyses (the state achieved by the long bones when they finish growing). For the full list of restrictions, see the Package Leaflet.
Somatropin can interfere with how the body uses insulin. Blood sugar levels need to be monitored during treatment, sometimes by starting insulin therapy or correcting it if necessary.
Why has NutropinAq been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the efficacy and safety of NutropinAq are generally comparable to those of other recombinant human growth hormone medicines. It was decided that the benefits of NutropinAq are greater than its risks for the treatment of growth hormone deficiency in adults and children. The CHMP therefore recommended the granting of a marketing authorization for NutropinAq.
More information about NutropinAq
On February 16, 2001, the European Commission granted Ipsen Ltd a "marketing authorization" valid throughout the European Union for NutropinAq. This authorization was renewed on February 16, 2006.
For the full evaluation version (EPAR) of NutropinAq, click here.
Last update of this summary: 10-2006.
The information on NutropinAq - somatropin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
