Somatropin Biopartners

What is Somatropin Biopartners and what is it used for?

Somatropin Biopartners is a medicine that contains the human growth hormone (also known as somatropin ). The medicine is indicated for the treatment of children aged between 2 and 18 who cannot grow normally because they have a low growth hormone production. It is also indicated in adults with growth hormone deficiency that may have manifested in childhood or developed into adulthood.

How is Somatropin Biopartners used?

Treatment with Somatropin Biopartners should be started and followed by a doctor with appropriate experience in the diagnosis and treatment of growth hormone deficient patients. The medicine can only be obtained with a prescription. Somatropin Biopartners is available as a powder and solvent to be reconstituted in a suspension for injection. Somatropin Biopartners should be administered subcutaneously once a week. The patient himself or his carer can inject Somatropin Biopartners after receiving appropriate instructions from a doctor or nurse. In children the recommended dose is 0.5 mg / kg of body weight given once a week. In adults, the recommended dose is 2 mg once a week for all patients, except for women receiving oral estrogen therapy, who must receive 3 mg once a week. The dose can be adjusted depending on the patient's response to treatment or the reported side effects. For more information, see the package leaflet.

How does Somatropin Biopartners work?

Growth hormone is a substance secreted by the pituitary gland or pituitary gland (a gland located at the base of the skull) that promotes growth in childhood and adolescence and influences the way the body assimilates proteins, fats and carbohydrates. The active substance in Somatropin Biopartners, somatropin, is identical to the human growth hormone. It is produced by a method known as "recombinant DNA technology", that is, it is obtained by cultivating yeast cells in which a gene (DNA) has been introduced that allows them to produce the hormone. Somatropin Biopartners replaces the natural hormone.

What benefit has Somatropin Biopartners shown during the studies?

Somatropin Biopartners has been studied in one main study involving 180 children with growth hormone deficiency. The study compared Somatropin Biopartners administered once a week with another somatropin medicine called Genotropin, given once a day. The main measure of effectiveness was the growth of patients one year after treatment. The study found that Somatropin Biopartners is as effective as Genotropin in promoting growth: children treated with Somatropin Biopartners grew about 11.7 cm in one year compared to children on Genotropin therapy, who grew by 12.0 cm in a year. Somatropin Biopartners has also been studied in one main study involving 151 adults with growth hormone deficiency. This study compared Somatropin Biopartners with placebo (a substance with no effect on the body) and measured the loss of body fat (which is normally high in adults with growth hormone deficiency) after 6 months of treatment. Adults treated with Somatropin Biopartners showed an average reduction in body fat of 1 kg compared to patients treated with placebo, which instead showed an increase in body fat of 0.5 kg.

What is the risk associated with Somatropin Biopartners?

In children the most common side effects of Somatropin Biopartners (which may affect more than 1 in 10 people) are swelling at the site of injection and antibody development (proteins that are produced in response to Somatropin Biopartners). However, these antibodies do not appear to affect the medicinal product's mode of action. In adults the most common side effects (which may affect more than 1 in 10 people) are swelling, mild hyperglycemia (increased blood sugar levels) and headache. For the full list of all side effects reported with Somatropin Biopartners, see the package leaflet. Somatropin Biopartners should not be used in patients with active cancer or with an acute life-threatening illness. For the full list of limitations, see the package leaflet.

Why has Somatropin Biopartners been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Somatropin Biopartners' benefits are greater than its risks and recommended that it be approved for use in the EU. The committee concluded that, in children who do not have normal statural growth, Somatropin Biopartners is as effective as other somatropin-based treatments given daily. In adults with growth hormone deficiency, Somatropin Biopartners has a modest effect on reducing body fat. As for its safety, the side effects reported with Somatropin Biopartners were similar to those of other somatropin-containing medicines taken daily, with the exception of an increased number of reactions at the injection site in children, which should be offset by the benefit from the weekly administration of the medicine.

What measures are being taken to ensure the safe and effective use of Somatropin Biopartners?

A risk management plan has been developed to ensure that Somatropin Biopartners is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Somatropin Biopartners, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Somatropin Biopartners will provide additional long-term data on the efficacy and safety of the medicine.

More information on Somatropin Biopartners

On 05.08.2013 the European Commission issued a marketing authorization for Somatropin Biopartners, valid throughout the European Union. For more information about treatment with Somatropin Biopartners, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 07-2013.