Solution for subcutaneous administration
Somatropin has a pronounced effect on the metabolism of fats, proteins and carbohydrates. In children with growth hormone deficiency (GH) deficiency, somatropin stimulates skeletal bone growth in length by acting on the pineal gland platelets. In both adults and children, somatropin helps normalize body structure by increasing muscle mass and reducing body fat. Visceral adipose tissue is especially sensitive to the action of somatropin. In addition to enhancing lipolysis, somatropin reduces the intake of triglycerides in body fat. Under the influence of somatropin, the concentration of insulin-like growth factor I (IRF-I) and the protein binding it (IRF-SB3, insulin-like growth factor binding protein) increases.
In addition, the following effects of
Fat Exchange have been demonstrated. Somatropin activates LDL receptors in the liver and changes the profile of lipids and lipoproteins in the blood. In general, the administration of somatropin to patients with GR deficiency leads to a decrease in blood LDL and apolipoprotein B. There is also a decrease in cholesterol concentration.
Carbohydrate metabolism. Somatropin increases the release of insulin, but the fasting concentration of glucose usually does not change. In children with hypopituitarism, the development of fasting hypoglycemia is possible. This condition is reversible with the introduction of somatropin.
Water-mineral exchange. GH deficiency is associated with a decrease in plasma volume and extracellular fluid. The appointment of somatropin leads to a rapid increase in both parameters. Somatropin promotes the retention of sodium, potassium and phosphorus.
Bone metabolism. Somatropin stimulates bone metabolism. Long-term treatment with somatropin in children with GR deficiency and osteoporosis leads to normalization of the mineral composition and bone density.
Physical activity. Long-term replacement therapy with somatropin leads to an increase in muscle strength and physical endurance. Cardiac output also rises, although the mechanism of this action is not fully understood. A decrease in peripheral vascular resistance may partially explain this effect of somatropin.
After sc administration, the bioavailability of somatropin is approximately 80% in both healthy individuals and patients with GH deficiency. When s / c administration of OmnitropÂ® at a dose of 5 mg to healthy volunteers, the plasma somatropin Cmax and its Tmax were respectively (72 Â± 28) Î¼g / l and (4 Â± 2) h.
Average T1 / 2 of somatropin after iv in the introduction to adult patients with a deficiency of GR is about 0.4 hours. However, after sc administration of T1 / 2 of the drug reaches 3 hours.
Separate patient groups
The absolute bioavailability of somatropin after sc administration is not different in men and women.
There is no data on the effect on the pharmacokinetic parameters of somatropin age, race, impaired liver, kidney or heart function.
In children with growth retardation due to the following diseases and conditions:
insufficient secretion of growth hormone
Prader-Willy syndrome (SPS)
chronic renal failure (CRF) by more than 50% reduction in function
children born with low growth rates for a given gestational age.
In adults, as a replacement therapy:
confirmed pronounced congenital or acquired growth hormone deficiency.
hypersensitivity to any component of the
drug malignant neoplasms
urgent conditions (including conditions after heart, abdominal, acute respiratory failure)
stimulation of growth in patients with closed epiphyseal growth zones
pregnancy and breastfeeding (breast-feeding should be avoided during treatment)
neonatal period (including premature babies) due to the presence of benzyl alcohol in the composition.
Caution: diabetes mellitus cranial hypertension concomitant therapy with corticosteroids hypothyroidism (including during replacement therapy with thyroid hormones).
1 ml of solution contains:
somatropin 6.7 mg,
sodium hydrogen phosphate heptahydrate,
sodium dihydrogen phosphate dihydrate,
benzyl alcohol (preservative),
phosphoric acid – qs to pH6.2 ÐÂ± 0.2,
sodium hydroxide – qs to pH6.2 ÐÂ± 0.2,
water d / u.
Dosage and administration
SC, slowly, 1 time per day, usually at night. The injection sites should be changed to prevent the development of lipoatrophy.
Doses are selected individually, taking into account the severity of GH deficiency, weight or body surface area, effectiveness in the process of therapy.
– with insufficient secretion of GR, a dose of 0.025-0.035 mg / kg / day or 0 is recommended, 71 mg / m2 / day
Treatment begins as early as possible and continues until puberty and / or until the closure of bone growth zones. Perhaps discontinuation of treatment when the desired result is achieved.
– with Shereshevsky-Turner syndrome, a dose of 0.045-0.05 mg / kg / day or 1.4 mg / m2 / day is recommended
– with SPV, the recommended dose is 0.035 mg / kg / day in children to increase growth and improve body composition in children or 1 mg / m2 / day. The daily dose of the drug should not exceed 2.7 mg. Treatment should not be prescribed to children with an increase in growth of less than 1 cm per year and with almost closed epiphyseal areas of
bone growth – with chronic renal failure accompanied by stunted growth, a dose of 0.045-0.05 mg / kg / day is recommended. With insufficient growth dynamics, higher doses of the drug may be required. A review of the optimal dose is possible after 6 months of
treatment – in case of growth disorders in children born with low growth rates for a given gestational age, a dose of 0.035 mg / kg / day or 1 mg / m2 / day is recommended until the desired growth is achieved. Treatment should be discontinued if, after the first year of treatment with the drug, the increase in growth does not exceed 1 cm.
Therapy should also be discontinued if the increase in growth does not exceed 2 cm per year and, based on the state of the pineal growth zones, if necessary, it is confirmed that age> 14 years (for girls) or> 16 years (for boys).
Doses recommended for children
Indications mg / kg / day mg / m2 / day
GR deficiency 0.0250.035 0.71
SPV 0.035 1
Shereshevsky-Turner syndrome 0.045-0.05 1.4
CRF 0.045 0.05 1, 4
Children with low birth height 0.035 1
In adults with severe GH deficiency, replacement therapy is recommended to start with low doses, 0.150.3 mg / day, followed by a gradual increase depending on the concentration of IRF-I in blood serum. This indicator should be within 2 deviations from the average for a given age. In patients with a normal initial concentration of IRF-I, the dose of the drug should be selected so that the values ??of IRF-I were on VGN, without going beyond 2 standard deviations from the average.
The maintenance dose is selected individually, but usually does not exceed 1 mg / day, which corresponds to 3 IU / day. Elderly are recommended lower doses.
A feature of patients with GH deficiency is an extracellular fluid volume deficiency. With the appointment of somatropin, this deficiency is quickly eliminated.
Adverse reactions associated with fluid retention, such as peripheral edema, are often observed in adult patients. stiffness of the extremities, arthralgia, myalgia and paresthesia. As a rule, the severity of these reactions varies from moderate to moderate, they develop in the first months of treatment and pass spontaneously or with a decrease in dose. The likelihood of these reactions depends on the dose of the drug, the patient’s age, and they are probably irreversibly related to age when GH deficiency occurs. In children, these side effects are unknown.
Benign, malignant and unspecified neoplasms: very rarely – leukemia. In very rare cases, children have had cases of leukemia with GH deficiency in the treatment with somatropin, but it was found that this frequency is similar to that in children with a normal concentration of GH.
From the side of the immune system: often – the formation of antibodies to somatropin. When prescribing somatropin, approximately 1% of patients develop antibodies to it. Binding Abilityl of these antibodies is small, and there have been no clinical manifestations of such antibody production.
From the endocrine system: rarely type 2 diabetes.
From the nervous system: often – paresthesia (in adults) infrequently – carpal tunnel syndrome (in adults), paresthesia (in children) rarely – benign intracranial hypertension.
From the side of musculoskeletal and connective tissue: often – stiffness of the limbs, arthralgia, myalgia (in adults) infrequently – stiffness of the limbs, arthralgia, myalgia (in children).
General disorders and disorders at the injection site: often – peripheral edema (in adults), transient skin reactions at the injection site (in children), infrequently – peripheral edema (in children).
Cases of overdose unknown.
Symptoms: an acute overdose can lead first to hypoglycemia, and then to hyperglycemia. With a prolonged overdose, signs and symptoms characteristic of an excess of human GH can be noted (the development of acromegaly and / or gigantism, as well as the development of hypothyroidism, a decrease in the concentration of cortisol in the blood serum).
Treatment: drug withdrawal, symptomatic therapy.
At 2-8 ° C (do not freeze).
The Expiration of
is 1.5 years.
solution for injection
Sandoz GmbH, Switzerland