SOMATIN® (Somatropin human recombinant)
International non-proprietary name: somatropin.
Main Properties: The drug is a powder of white or almost white color. Solvent is a clear, colorless or slightly yellowish liquid.
Qualitative and quantitative composition
active ingredient - 1 bottle of the drug contains recombinant human Somatropin - 1.3 mg (4 IU) or 2.6 mg (8 IU)
Excipients: mannitol, glycine, sodium dihydrogenphosphate dihydrate (as anhydrous), disodium phosphate dihydrate (based on anhydrous);
solvent: metacresol, mannitol, water for injections.
Form of release
Lyophilizate for solution for injection at 1.3 mg (4 IU) or 2.6 mg (8 IU) in vial № 1, complete with a solvent (0.3% solution of metacresol), respectively 1.0 ml or 2.0 ml, ampoules No. 1.
PBX code. Н01АС01. Hormones of the anterior part of the pituitary gland and their analogues. Somatropin
Immunobiological and biological properties. Somatropin is a single chain polypeptide consisting of 191 amino acid residues (Human Growth Hormone), which is produced by genetically modified Escherichia sol culture using recombinant DNA technology. Somatropin is a metabolic hormone that affects the metabolism of lipids, carbohydrates and proteins. In children with endogenous growth hormone deficiency, somatropin accelerates the linear growth of the skeleton and the rate of growth by affecting the epiphysis tubular bone plates, bone metabolism. In patients with growth hormone deficiency and osteoporosis, substitution therapy leads to the normalization of the mineral composition and density of bones. Somatropin increases the number and size of cells of the muscles, liver, rectum, gonads, adrenal glands, thyroid gland; stimulates transport of amino acids into the cell and synthesis of proteins; lowers cholesterol levels, affects the profile of lipids and lipoproteins; suppresses insulin release; promotes delayed sodium, potassium and phosphorus; increases body weight, muscular activity and physical endurance.
The bioavailability of the subcutaneously administered drug is 80%. The maximum concentration in the blood is reached in 3-6 hours. The half-life is 2-3 hours.
Indications for use
Growth failure with insufficient secretion of growth hormone (growth hormone deficiency (GHR);
violation of growth in dysgenesis of gonads (Shereshevsky-Turner syndrome);
violation of growth in puberty period in chronic renal failure;
growth disturbance (the magnitude of the standard deviation (SD) of current growth <-2.5 and the magnitude of the standard deviation of genetically determined growth <-1) in low birth-born children with a height below the age-old norm born with weight and / or body length less - 2 standard deviations, and could not reach the age-old growth rate (the value of the standard deviation of the growth rate <0 during the last year) until they reach 4 years of age or more;
Breeding growth with Prader-Willie syndrome in order to improve the growth and structure of the body. Diagnosis of Prader-Willy syndrome should be confirmed by appropriate genetic tests.
Somatin® is indicated as a substitution therapy in adults with severe growth hormone deficiency associated with multiple hormonal deficiencies due to known pathologies of the hypothalamus or pituitary gland, as well as those with at least one of the pituitary hormones deficiency, with the exception of prolactin. Such patients should undergo an appropriate dynamic test to determine whether or not there is a growth hormone deficiency.
For patients who have had a growth factor deficiency even in childhood (as a result of inborn, genetic, acquired or idiopathic causes), the ability to produce a growth hormone after long-term growth should be re-evaluated. For patients with a high probability of persistent ADHD, for example, in the case of congenital or secondary ADHD due to hypothalamic-pituitary or stroke, a CS of insulin-like growth factor (IRF-I) <-2 without treatment with a growth hormone for at least 4 weeks should be considered a sufficient basis for the diagnosis of DHA . For all other patients, an IRF-I and one hormone stimulation test is sufficient.
Preparation of the drug solution
Dissolve the contents of a vial with activity of 4 IU (1.3 mg) in 1 ml of a solvent, with activity of 8 MO (2.6 mg) - in 2 ml of the solvent added, based on the calculated dose. To do this, select the solvent with a syringe and slowly enter into the vial with the drug through the plug, gently swinging to completely dissolve the contents of the vial. Sharp shaking is unacceptable. This can lead to the denaturation of the active components.
Adult patients have side effects due to fluid retention, namely peripheral edema, pastosity of the lower extremities, arthralgia, myalgia and paresthesia. These phenomena, of course, weakly or moderately expressed, manifest during the first months of treatment and disappear themselves or after reducing the dose of the drug. The frequency of these side effects depends on the dose of somatropin, the age of the patients and may be inversely proportional to the age at which the growth hormone was deficient. In children, side effects are rare.
When using Somatropin, isolated cases of type II diabetes mellitus are possible. In adults, carpal tunnel syndrome can sometimes be observed. It is also possible to reduce the level of cortisol in the serum, which may be due to the action of somatropin on transport proteins.
The incidence of leukemia does not differ from that in children with no growth hormone deficiency. Occasionally, benign intracranial hypertension develops.
Possible reduction of thyroid function, hyperglycemia, epiphyseosis, pancreatitis. During treatment it is advisable to control the titre of antibodies to the hormone of growth in the blood, thyroid and adrenal glands.
Reaction at the injection site, increased sensitivity to solvent, which may cause myositis.
Somatropin should not be prescribed in the presence of signs of tumor growth. Anti-tumor therapy should be completed before commencing treatment with Somatropin.
Somatropin is not intended as a growth stimulator for children with closed epiphyses of tubular bones.
Treatment with Somatropin is contraindicated in patients in critical condition, which has been acutely developed as a consequence of surgery in the open heart or abdominal cavity, multiple trauma and acute respiratory insufficiency.
The drug is contraindicated in case of hypersensitivity to the active substance or other components included in its composition.
Acute overdose can lead to hypoglycemia with the subsequent development of hyperglycemia. Therapy is symptomatic. Long-term overdose can lead to gigantism, acromegalia (excessive growth).
Somatin® injections are subcutaneously administered to areas where subcutaneous fat is present: in the abdomen, the anterior surface of the thighs, the back side of the shoulder, the upper part of the buttocks.
It is necessary to change the places of hypodermic injections due to the possibility of development of lipoatrophy.
Somatropin may cause insulin resistance and hyperglycaemia in some patients, in which case patients should be monitored for reducing glucose tolerance. On the background of Somatin® treatment, it may be necessary to correct the doses of sugar-reducing drugs in patients with diabetes mellitus. There may be a manifestation of latent hypothyroidism, and in patients receiving thyroxine, signs of hyperthyroidism may appear. In this regard, it is recommended to conduct a thyroid gland study after commencing treatment with somatropin and after changing the dose of the dose.
During treatment it is necessary to control the condition of the fundus, especially with symptoms of intracranial hypertension. Swelling of the optic nerve requires the discontinuation of the drug. The detection of lameness against the background of Somatin therapy requires careful observation.
In patients with Prader-Willie syndrome, the use of the drug should always be combined with a low calorie diet.
Prior to treatment with somatropin in Patients with Prader-Willi's syndrome, symptoms of upper respiratory tract obstruction, sleep apnea or the presence of respiratory infections should be detected. If these pathologies are detected, the child should be directed to an otolaryngologist for the treatment and elimination of respiratory distress before treatment. If during treatment of patients with somatropin there are symptoms of upper airway obstruction (including the appearance and increase of snoring), treatment should be interrupted and reconsidered by an otorhinolaryngologist. All patients with Prader-Willy syndrome should be monitored for the probability of sleep apnea. Patients should be screened for symptoms of respiratory infections that should be diagnosed as early as possible and actively treated.
All patients with Prader-Willie syndrome need to monitor body weight before and during treatment with a growth hormone.
When using the drug, you should monitor the signs of scoliosis.
In determining the indications for the treatment of low birth-rate babies with an under-the-age increase, the causes of low growth should be established before treatment commences. Such children should determine the level of insulin and glucose in the blood before starting treatment and repeat this study every year.
Patients at high risk of developing diabetes should be prescribed with caution and have an oral glucose tolerance test.
The drug should be used with caution in patients with renal insufficiency.
Before entering, take the vial from the refrigerator and do not stand at room temperature
less than 30 minutes.
Use during pregnancy or breastfeeding
Clinical experience of using the drug during pregnancy is limited. During the physiological pregnancy, the level of the pituitary hormone of growth decreases significantly after 20 weeks and is almost completely replaced by a placental hormone of growth for 30 weeks. Based on this, it is unlikely that the continuation of replacement therapy with growth hormone will be necessary in women with a deficit in the third trimester of pregnancy.
There is no reliable information on the possibility of excretion of peptide hormones with breast milk, but in any case absorption of intact protein in the digestive tract of a child is unlikely.
Interaction with other medicinal products
Glucocorticosteroids can slow down the therapeutic effect of somatropin. Where appropriate, glucocorticoid replacement therapy should be carefully monitored for dosing and compliance to prevent the development of adrenal insufficiency or inhibition of growth stimulation effects.
Somatropin is an inducer of cytochrome P450 (CYP) activity, which may decrease blood plasma concentrations and decrease the efficacy of cytochrome CYP3A-metabolised drugs such as sex hormones, corticosteroids, cycloserol and anticonvulsants.
Impact on the ability to drive vehicles and work with mechanisms. There were no manifestations of influence on the ability to drive a car and work with mechanisms.
Store in a dry place protected from light at a temperature from 2 to 8 oC.
Before the dilution, the preparation can be stored at room temperature (not above 25 ºС).
The prepared solution can be stored in a vial for no more than 15 days at a temperature from 2 to 8 oC.
Do not freeze!
Conditions of release
By 1.3 mg (4 IU) or 2.6 mg (8 IU) of the drug in a bottle; respectively 1.0 ml or 2.0 ml of solvent in an ampoule.
1 vial with the preparation and 1 ampoule with solvent in the blister. 1 blister in a pack