What is SOMAVERT?
SOMAVERT consists of a powder and a solvent to be mixed together to obtain a solution for injection. SOMAVERT contains the active ingredient pegvisomant (10, 15 or 20 mg / ml).
What is SOMAVERT used for?
SOMAVERT is used to treat patients with acromegaly (a rare hormonal disorder due to excessive production of growth hormone by the pituitary gland, which usually affects middle-aged adults).
SOMAVERT is used in patients who have not responded adequately to surgery or radiotherapy or to drug therapy with somatostotin analogues (another kind of drug used in the treatment of acromegaly).
Because the number of patients with acromegaly is low, the disease is considered rare and SOMAVERT was designated an "orphan medicine" (a medicine used in rare diseases) on February 14, 2001.
The medicine can only be obtained with a prescription.
How is SOMAVERT used?
Treatment with SOMAVERT should be started under the supervision of a physician experienced in the treatment of acromegaly. SOMAVERT is given by subcutaneous injection (under the skin).
The patient receives an initial dose of 80 mg under medical supervision. Subsequently, 10 mg of the medicine should be given once a day, by subcutaneous injection. The patient himself or the person in charge of him can inject SOMAVERT after receiving appropriate instructions from a doctor or nurse. The doctor should measure the response every four to six weeks and adjust the dose if necessary. The maximum dose should not exceed 30 mg / day.
How does SOMAVERT work?
Acromegaly occurs because the pituitary gland, the gland located in the lower part of the brain, produces excess growth hormones, usually as a result of a benign tumor. Growth hormone is responsible for the growth of the body during childhood and adolescence.
In acromegaly, this excess production induces an abnormal growth of the bones and a thickening of the soft tissues (for example, hands and feet); it also causes heart disease and other ailments. The active ingredient in SOMAVERT, pegvisomant, is very similar to the human growth hormone, but has been designed to block receptors with which the growth hormone usually binds. In this way, it prevents the growth hormone from becoming effective. SOMAVERT is therefore able to prevent unwanted abnormal development and other disorders typical of acromegaly.
Pegvisomant is produced with a method known as "recombinant DNA technology": that is, it is obtained from a bacterium in which a gene (DNA) has been inserted that makes it capable of producing the substance.
What studies have been carried out on SOMAVERT?
SOMAVERT has been studied in 112 patients with acromegaly during a 12-week study.
Three different doses of the drug (10, 15 or 20 mg / day) were compared with a placebo (a dummy treatment). Treatment efficacy was measured by comparing IGF-I (insulin-like growth factor I) levels at the start and end of the study. The IGF-1 factor is regulated by human growth hormone and is responsible for body growth.
What benefit has SOMAVERT shown during the studies?
SOMAVERT reduced IGF-1 levels to all doses tested. The IGF-I value was within the normal limits at the end of the study (week 12) in 38.5%, 75% and 82% of patients treated with SOMAVERT 10, 15 or 20 mg / day, respectively (compared to 9.7% of patients treated with placebo).
What is the risk associated with SOMAVERT?
The most frequent undesirable effects detected with SOMAVERT during the clinical trial were injection site reactions (observed in 11% of patients), sweating (7%), headache (6%) and asthenia (loss of strength and energy, 6%). Some patients treated with SOMAVERT have developed anti-growth hormone antibodies (proteins produced by the body in response to the medicine). For the full list of all side effects reported with SOMAVERT, see the Package Leaflet.
SOMAVERT should not be used in patients who are potentially hypersensitive (allergic) to pegvisomant or any of the other substances. The risk of hypoglycaemia (low blood sugar) was observed in diabetic patients receiving SOMAVERT therapy; therefore in these patients it may be necessary to modify the antidiabetic therapy.
Why has SOMAVERT been approved?
The Committee for Medicinal Products for Human Use (CHMP) has decided that the benefits of SOMAVERT outweigh the risks in the treatment of patients with acromegaly who have not responded adequately to surgery and / or radiotherapy and for whom appropriate therapy pharmacological with somatostotine analogues has been shown to be ineffective in normalizing IGF-I concentrations or was not tolerated. The Committee recommended that SOMAVERT be given marketing authorization.
More information on SOMAVERT
On 13 November 2002, the European Commission granted a marketing authorization for SOMAVERT, valid throughout the European Union, to Pfizer Limited. The authorization was renewed on 13 November 2007.
To register as a SOMAVERT orphan medicinal product, click here.
For the full EPAR of SOMAVERT click here.
Last update of this summary: 11-2007.
