Omnitrope - somatropin

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 has already been authorized in the European Union (EU) and contains the same active substance (for this so-called reference medicine). The reference medicine for Omnitrope is Genotropin. For more information on biosimilar medicines, read the "question and answer" document below.

What is Omnitrope used for?

Omnitrope is used to treat children:

with growth problems due to a growth hormone (GH) deficiency;
of short stature due to chronic renal failure (renal dysfunction) or to a genetic disorder called Turner syndrome;
of short stature because born small in relation to the gestational age and that they have not recovered at the age of four years 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 analyzes.

Omnitrope is also used as a replacement therapy for adults with marked growth hormone deficiency as a replacement therapy.

The medicine can only be obtained with a prescription.

How is Omnitrope used?

Treatment with Omnitrope should be supervised by a doctor experienced in the management of subjects with growth disorders. Omnitrope is given by subcutaneous injection (under the skin) once a day before bedtime. The injection can also be given by the patient or by the person assisting him, following instructions given by the doctor or a nurse. Omnitrope cartridges should only be used with the special Omnitrope injection equipment. The doctor establishes the dose for each patient based on body weight and clinical conditions; over time it may be necessary to change the dose, depending on changes in body weight and patient response.

How does Omnitrope work?

Growth hormone is produced by the pituitary gland (gland located at the base of the brain). It promotes growth during childhood and adolescence and also intervenes on how the body handles proteins, fats and carbohydrates. The active substance in Omnitrope, 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 that becomes able to produce the hormone. Omnitrope replaces the naturally produced hormone.

How has Omnitrope been studied?

Omnitrope has been studied to verify its analogy with the reference medicine, Genotropin. The comparison was carried out on 89 children with GH deficiency who had not been treated previously. The study, which lasted nine months, recorded the height at the beginning and end of the study and the speed of growth. To study its safety aspects, Omnitrope was given to another 51 children for up to a year.

What benefit has Omnitrope shown during the studies?

At the end of the nine months, treatments with Omnitrope and Genotropin showed a similar increase in height and growth rate (equal 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 found with Omnitrope are similar in type and grade to those found with the reference medicine (Genotropin). The most common side effects (observed with a frequency varying from 1 to 10 patients out of 100) are: in children, transient local skin reactions at the injection site and in adults, moderate edema (fluid accumulation), paresthesia (numbness or tingling ), muscle and joint pain (especially in the hip and knee) and limb stiffness. Furthermore, similarly to what happens with all protein-containing medicines, some patients may develop antibodies (proteins produced in response to Omnitrope), which however do not have inhibitory effects on growth. For the full list of all 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 the solvent used with Omnitrope 5 mg / ml contain benzyl alcohol). Omnitrope should not be used if the patient has an active tumor or an acute life-threatening illness. For the full list of usage restrictions, see the package leaflet.

Somatropin may affect the natural use of insulin. During the treatment it will be necessary to monitor blood sugar levels, possibly starting an insulin therapy or modifying it if already in progress.

Why has Omnitrope been approved?

The Committee for Medicinal Products for Human Use (CHMP) believes that, based on the requirements in the EU, 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?

Measures taken to ensure safe use of Omnitrope are related to the reasons the medicine is used. The Omnitrope manufacturer has undertaken to study in more detail the possible long-term side effects of the medicine, such as the possible risk of developing diabetes or reappearance of certain types of cancer in the case of prolonged treatment with somatropin as well as the effects on efficacy deriving from the development of antibodies.