What is Omnitrope?
Omnitrope is a medicine that contains the active substance somatropin. It is available as a solution for injection obtained by mixing a powder and a solvent (1.3 or 5 mg / ml) or as a ready-to-use solution in cartridges (3.3 or 6.7 mg / ml).
Omnitrope is a biosimilar medicine, which means that it is similar to another biological medicine that is already authorized in the European Union (EU) and contains the same active substance (for this reference medicine). The reference medicine of Omnitrope è Genotropin For more information on biosimilar medicines, please read the question and answer document below.
What is Omnitrope used for?
Omnitrope is used to treat children:
- with growth problems due to growth hormone (GH) deficiency;
- short stature due to chronic kidney failure (kidney dysfunction) or a genetic disorder called Turner syndrome;
- of short stature because they were born small in relation to their gestational age and who did not recover at the age of four or later;
- suffering from Prader-Willi syndrome, a genetic disease; in this case Omnitrope serves to improve growth and body structure (the ratio between fat mass and muscle mass). In this case the diagnosis must be confirmed by appropriate genetic analysis.
Omnitrope is also used as a replacement therapy for adults with marked growth hormone deficiency, such as replacement therapy.
The medicine can only be obtained with a prescription.
How is Omnitrope used?
Omnitrope treatment should be supervised by a physician experienced in the management of people with growth disorders. Omnitrope is given by injection under the skin (under the skin) once a day at bedtime. The injection can also be given by the patient or their caregiver following instructions given by the doctor or nurse. Omnitrope cartridges should only be used with Omnitrope's special injection equipment. The doctor determines the dose for each patient. based on body weight and clinical condition; the dose may need to be adjusted over time, depending on changes in body weight and patient response.
How does Omnitrope work?
Growth hormone is produced by the pituitary gland (gland at the base of the brain). It promotes growth during childhood and adolescence and also affects the way the body handles proteins, fats and carbohydrates. Omnitrope's active ingredient, somatropin, is identical to the growth hormone produced by the body. It is produced with the so-called "recombinant DNA technology", that is, by inserting a gene (DNA) into a bacterium which thus becomes capable of producing the hormone. Omnitrope replaces the naturally produced hormone.
How has Omnitrope been studied?
Omnitrope was studied to see how similar it is to the reference medicine, Genotropin. The comparison was made on 89 children with GH deficiency who had not been treated before. The study, which lasted nine months, recorded the " height at the start and at the end of the study and the rate of growth. To investigate safety aspects, Omnitrope was given to a further 51 children for up to one year.
What benefit has Omnitrope shown during the studies?
At the end of the nine months, Omnitrope and Genotropin treatments showed a similar increase in height and growth rate values (equivalent to an increase of 10.7 cm / year with both drugs). The efficacy of Omnitrope was found to be equivalent to the efficacy of Genotropin.
What is the risk associated with Omnitrope?
The side effects seen with Omnitrope are similar in type and degree to those seen with the reference medicine (Genotropin). The most common side effects (seen with a frequency ranging from 1 to 10 patients in 100) are: in children, transient local skin reactions at the injection site and in adults, moderate edema (fluid accumulation), paraesthesia (numbness or tingling ), muscle and joint pain (especially in the hip and knee) and stiffness in the limbs. Also, as with all protein-containing medicines, some patients may develop antibodies (proteins produced in response to Omnitrope), which however have no growth inhibitory effects. For the full list of side effects reported with Omnitrope, see the package leaflet.
Omnitrope should not be used in patients who may be hypersensitive (allergic) to somatropin or any of the other ingredients (the ready-to-use solution and solvent used with Omnitrope 5 mg / ml contain benzyl alcohol). Omnitrope should not be used if the patient has active cancer or acute, life-threatening disease. For a complete list of restrictions on use, see the package leaflet.
Somatropin can affect the natural use of insulin. Blood sugar levels should be monitored during treatment, possibly starting insulin therapy or modifying it if already in progress.
Why has Omnitrope been approved?
The Committee for Medicinal Products for Human Use (CHMP) considers that, based on EU requirements, Omnitrope has demonstrated a comparable profile to that of Genotropin with regard to quality, safety and efficacy. The CHMP therefore considers that, as in the case of Genotropin, the benefits outweigh the identified risks.
What measures are being taken to ensure the safe use of Omnitrope?
The measures taken to ensure the safe use of Omnitrope are linked to the reasons why the medicine is used. The company that makes Omnitrope has undertaken to investigate in greater depth the possible long-term side effects of the medicine, such as the possible risk of developing diabetes or the reappearance of certain types of cancer in the event of prolonged treatment with somatropin as well as the repercussions on efficacy deriving from the development of antibodies.
Learn more about Omnitrope:
On 12 April 2006, the European Commission granted Sandoz GmbH a "Marketing Authorization" for Omnitrope, valid throughout the EU.
For the full version of Omnitrope's EPAR, click here.
Last update of this summary: 03-2008
The information on Omnitrope - 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.
