WHAT IS OMNITROPE?
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.
HOW IS IT USED
Omnitrope can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with growth disorders.
The medicine is available as a powder and solvent, which are made up into a solution for injection, or as a ready-to-use solution in a cartridge. It is given by injection under the skin, once a day. The patient or caregiver can inject Omnitrope, after being trained by a doctor or a nurse. The Omnitrope cartridges should only be used with the special Omnitrope injection device. The doctor calculates the dose for each patient individually according to the body weight and the condition being treated. The dose may need to be adjusted over time, depending on change in body weight and response to treatment.
For further information, see the package leaflet.
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.
ITS SIDE EFFECTS
n adults, side effects related to fluid retention, such as peripheral oedema (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). Howeve,r these antibodies do not have an effect on how well Omnitrope works. For the full list of side effects of Omnitrope, see the package leaflet.