SAIZEN ® - Somatotropin: growth hormone

SAIZEN ® is a drug based on recombinant human growth hormone

THERAPEUTIC GROUP: Hormones of the anterior pituitary lobe and analogues

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications SAIZEN ® - Somatotropin: growth hormone

SAIZEN ® is used clinically for the treatment of pathologies characterized by growth hormone deficiency in children and adults.

More precisely in children it is successfully used in the treatment of Turner syndrome and in growth disorders in short children born small for gestational age.

In adults, on the other hand, it is used in replacement therapy in patients with congenital growth hormone deficiency or secondary to hypothalamic or pituitary diseases.

Mechanism of action SAIZEN ® - Somatotropin: growth hormone

Growth hormone (GH) is a hormone of protein nature, consisting of 191 amino acids and secreted by the adenohypophysis, according to specific circadian rhythms and according to the different needs of the organism .

Its importance from the functional point of view is absolute since it intervenes in the regulation of the metabolic activities of various tissues, promoting the anabolic phase and counteracting the catabolic one, thus exerting an intense growth activity useful for the correct development of organs and systems.

The aforementioned activities, particularly intense at the muscular, hepatic, lymphocytic and hematopoietic level, seem to be carried out from the molecular point of view, through a mediator downstream of the biological signal, represented by the IGF 1 -2, known as somatomedins, capable of reprogramming the gene expression of target cells, supporting the growth phase.

In a synthetic way, this hormone intervenes in the:

Protein synthesis process, supporting muscular and skeletal development;
Oxidation of fatty acids, improving the energy yield of the body favoring the loss of fat mass;
Carbohydrate metabolism, stimulating hyperglycemia;
Immune control, increasing the number and competence of immune system cells;
Erythropoiesis improving the differentiation of mature erythrocytes.

From a pharmacological point of view, this hormone is obtained through recombinant DNA technology, thus limiting the risks related to the organic extraction of GH, and administered parenterally by injection, given the high susceptibility to proteases present in the gastro-intestinal tract.

Studies carried out and clinical efficacy

1. CLINICAL CHARACTERISTICS OF PEDIATRIC PATIENTS IN THERAPY WITH GH

Epidemiological study conducted between the United States and Canada demonstrating that SAIZEN treatment is effective and safe for pediatric patients. Of these, about 70% were male and suffered from idiopathic growth hormone deficiency.

2. EFFECTIVENESS OF GH AND GENDER

Work that shows how GH replacement therapy can be well tolerated in adult patients with side effects mainly related to water retention. The benefits on body composition were more intense in men (increase of about 3 kg of lean mass) while the improvement in cardiac function was almost identical between the two genders.

3. THE EFFECTS OF GH ON MALNUTRIC PATIENTS

Low doses of Gh for 4 weeks proved to be effective in improving the overall health status and quality of life of malnourished elderly patients. The increase of the lean mass and the improvement of the motor functions have been decidedly more accentuated than those obtained with the dietary intervention alone.

Method of use and dosage

SAIZEN ®

Powder and solvent for 8 mg somatotropin solution for injection:

the definition of the specific dosage is up to the competent doctor, after having evaluated the physio-pathological characteristics of the patient, the severity of the clinical picture and the related therapeutic objectives.

The dosing schedule which should follow different phases, characterized by the gradual increase of the dosage, must necessarily be accompanied by haematochemical analyzes useful for evaluating the patient's health status and the biological efficacy of the therapy.

In principle the maximum dosage is always limited to 1 mg of GH per day.

Warnings SAIZEN ® - Somatotropin: growth hormone

The biological complexity of GH therapy requires the supervision of a specialist doctor both in the definition phase of the dosage and throughout the therapeutic process, in order to avoid the appearance of serious side effects and at the same time to evaluate the clinical efficacy of the therapy.

The entire treatment period must be combined with periodic medical examinations and control of thyroid function, glucose metabolism, renal function, leukocyte formula and neurological function.

At the onset of the first side effects, the doctor should evaluate the possible need to suspend therapy in order to avoid the aggravation of the clinical picture.

The exogenous administration of growth hormone may in some cases be associated with the appearance of anti-somatotropin antibodies, which can significantly reduce therapeutic efficacy and compromise the results.

In order to avoid unpleasant side effects at the injection site, including lipodystrophy, it would be ideal to rotate, according to the doctor's indications, the site of inoculation of the hormone.

PREGNANCY AND BREASTFEEDING

The absence of studies able to characterize the safety profile of GH on the health of the fetus when taken during pregnancy or during the subsequent period of breastfeeding does not allow the use of this hormone during these periods.

Interactions

The activity of somatotropin could be compromised or inhibited by the simultaneous intake of glucocorticoids, while it could at the same time induce the activity of the cytochrome p450, resulting in an increased metabolism of various active ingredients, substrates of these enzymes, thus a consequent reduction in their effectiveness therapeutic.

Contraindications SAIZEN ® - Somatotropin: growth hormone

The use of SAIZEN ® is contraindicated in case of malignant neoplastic diseases, of recent major surgery, of severe kidney disease and kidney transplants, and of hypersensitivity to the active ingredient or to one of its excipients.

Undesirable effects - Side effects

The side effects described following the use of SAIZEN ® involve different organs and systems with a varied clinical course, which tends to worsen in terms of frequency and extent when the administration of this hormone disregards the real medical needs trespassing into doping practice.

More precisely, water retention, peripheral edema, arthralgia, myalgia, paraesthesia and intracranial hypertension are the most frequently documented adverse reactions together with cutaneous manifestations during administration.

Headache, slipping of the epiphysis of the femoral head with necrosis, insulin resistance, hypothyroidism and increased risk of leukemia, as documented by some studies, are instead the potential side effects that are of greater concern from the medical point of view.