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Genotropin® contains syntactized with the help of recombinant technologies somatropin, identical to human growth hormone. In children with deficiency of endogenous growth hormone and Prader-Willi syndrome, somatropin enhances and accelerates the linear growth of the skeleton. In both adults and children, somatropin maintains a normal body structure, stimulating muscle growth and facilitating the mobilization of fat. Visceral adipose tissue is particularly sensitive to somatropin. In addition to stimulating lipolysis, somatropin reduces the flow of triglycerides to the fat stores.

 

Somatropin increases the concentration of insulin-like growth factor (IRP-I) and IRP-binding protein (IRFSB-3) in serum.

 

In addition to the above properties, the following effects of somatropin were shown:

 

Lipid exchange
Somatropin stimulates the hepatic receptors of low density lipoproteins (LDL) and affects the profile of lipids and lipoproteins in the blood serum. In general, the use of somatropin in patients with a deficiency of growth hormone leads to a decrease in the concentration of LDL and apolipoprotein B in the blood serum. There may also be a decrease in the concentration of total cholesterol.

 

Exchange of carbohydrates
Somatropin increases the concentration of insulin, however, the fasting glucose concentration usually does not change. Children with hypopituitarism may have fasting hypoglycaemia. Somatropin stops this condition.

 

Water-salt exchange
The lack of growth hormone is associated with a decrease in the volume of plasma and tissue fluid. Both these indicators increase rapidly after treatment with somatropin. Somatropin promotes the retention of sodium, potassium and phosphorus.

 

Bone Metabolism
Somatropin stimulates bone metabolism. In patients with growth hormone deficiency and osteoporosis, prolonged treatment with somatropin leads to the restoration of mineral composition and bone density.

 

Physical performance
Treatment with somatropin increases muscle strength and physical endurance. Somatropin also increases cardiac output, but the mechanism of this effect has not yet been elucidated. A certain role in this may play a decrease in peripheral vascular resistance.

 

Mental status
In patients with growth hormone deficiency, there may be a decrease in mental abilities and changes in mental status. Somatropin increases vitality, improves memory and affects the balance of neurotransmitters in the brain.

Suction
As in healthy individuals, and in patients with insufficiency of growth hormone, approximately 80% of the administered scatomatropine is absorbed. After subcutaneous administration of somatropin at a dose of 0.1 IU / kg, the maximum concentration and time of its attainment in blood plasma are 13-35 ng / ml and 3-6 hours, respectively.

The average volume of distribution is 1.3 l / kg.

 

Excretion
The average half-life after intravenous administration of somatropin in patients with growth hormone deficiency is about 0.4 hours. With subcutaneous administration of the drug, the half-life period reaches 2-3 hours. The observed difference is probably associated with a slower absorption with subcutaneous injection. Metabolized in the kidneys and liver, about 0.1% in unchanged form is excreted with bile.

 
Subpopulations
Absolute bioavailability of somatropin with subcutaneous injection is the same in males and females.

Children:

• Growth retardation with insufficient growth hormone secretion;
• Growth retardation in Shereshevsky-Turner syndrome;
• Growth retardation in chronic renal failure;
• Intrauterine growth retardation (in children who have not reached the normative growth rates until the age of 2 years);
• Growth retardation in patients with Prader-Willy syndrome.

 
Adults
A confirmed expressed congenital or acquired growth hormone deficiency (as a substitute therapy) in patients who meet one of the following two criteria:

• manifestation of the disease in adults: patients who have only a deficiency of growth hormone or in combination with the deficiency of other hormones (hypopituitarism), as a result of pituitary, hypothalamic, surgical, radiotherapy or trauma;
• manifestation of the disease in children: patients who have had growth hormone deficiency in childhood, due to congenital, genetic, acquired or idiopathic causes.

Hypersensitivity to any of the components of the drug.

Presence of symptoms of tumor growth, including uncontrolled growth of a benign intracranial tumor. Antitumor therapy should be completed before starting treatment with Genotropin®.

Active malignant neoplasms of any localization.

Critical condition, acute development in patients as a result of open heart or abdominal surgery, multiple trauma and acute respiratory failure.

If during the replacement therapy with growth hormone a patient has a critical condition for any reason, the risk-benefit ratio should be evaluated from the continuation of treatment in this case.

Heavy forms of obesity (weight / height ratio exceeds 200%) or severe respiratory disorders (see section "Special instructions") in patients with Prader-Willi syndrome.

Stimulation of growth in children after the closure of the growth zones of the epiphyses of tubular bones.

Pregnancy.

 

CAREFULLY

Diabetes mellitus, intracranial hypertension (see section "Side effect"), hypothyroidism (see section "Special instructions"), the period of breastfeeding, concomitant therapy with glucocorticosteroids, Prader-Willi syndrome.