Omnitrope is also known as human growth hormones (hGH or HGH) in its human form, is a peptide hormone that stimulates growth, cell reproduction, and cell regeneration in humans and other animals. It is thus important in human development. GH also stimulates the production of IGF-1 and increases the concentration of glucose and free fatty acids. It is a type of mitogen which is specific only to the receptors on certain types of cells. GH is a 191-amino acid, single-chain polypeptide that is synthesized, stored, and secreted by somatotropic cells within the lateral wings of the anterior pituitary gland.
A recombinant form of hGH called somatreopleopin (INN) is used as a prescription drug to treat children’s growth disorders and adult growth hormone deficiency. In the United States, it is only available legally from pharmacies by prescription from a licensed health care provider. In recent years in the United States, some health care providers are prescribing growth hormones to the elderly to increase vitality. While legal, the efficacy and safety of this use for HGH have not been tested in a clinical trial. Many of the functions of hGH remain unknown.
In its role as an anabolic agent, HGH has been used by competitors in sports since at least 1982 and has been banned by the IOC and NCAA. Traditional urine analysis does not detect doping with HGH, so the ban was not enforced until the early 2000s when blood tests that could distinguish between natural and artificial HGH were starting to be developed. Blood tests conducted by WADA at the 2004 Olympic Games in Athens, Greece targeted primarily HGH. The use of the drug for performance enhancement is not currently approved by the FDA.
WHAT IS OMNITROPE?
Growth hormone or somatotropin, also known as human growth hormones in its human form, is a peptide hormone that stimulates growth, cell reproduction, and cell regeneration in humans and other animals. It is thus important in human development.
Omnitrope is a medicine used to treat children who:
- do not grow normally because they do not have enough growth hormone;
- are short because they have long-term kidney disease or a genetic disorder called Turner syndrome;
- are short and were born small for their gestational age, and have not caught up by the age of 4 years or later;
- have a genetic condition called Prader-Willi syndrome. Omnitrope is given to improve their growth and body composition (by reducing fat and improving muscle mass). The diagnosis must be confirmed by genetic testing.
Omnitrope is also used as replacement therapy in adult patients with pronounced growth hormone deficiency. The deficiency can have started in adulthood or childhood and needs to be confirmed by testing before treatment.
Omnitrope contains the active substance somatropin and is a ‘biosimilar’ medicine. This means that Omnitrope is highly similar to a biological medicine (the ‘reference medicine’) that is already authorized in the EU.
Omnitrope was studied to show that it is comparable to the reference medicine, Genotropin. Omnitrope was compared with Genotropin in 89 children with a lack of growth hormone who had not been treated before. Results showed that, after treatment for 9 months, Omnitrope was as effective as Genotropin in improving growth. Children receiving Omnitrope and Genotropin grew at a similar rate of about 10.7 cm per year.
In adults, side effects related to fluid retention, such as peripheral edema (swelling, especially of the ankles and feet), paraesthesia (numbness or tingling), joint and muscle pain, and stiffness of the limbs are common (may affect between 1 and 10 patients in 100). These side effects are uncommon in children (may affect between 1 and 10 patients in 1,000). As with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Omnitrope).