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Saizen
Last reviewed: 03.07.2025
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The medicinal product Saizen® (Saizen) manufactured by Merck Serono (Switzerland) belongs to the pharmacological group of hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists.
The active substance of the drug is the synthetic growth hormone somatropin (somatotropic hormone), obtained using modern recombinant DNA technology of mammalian cells modified by the addition of the human growth hormone gene.
Indications Saizen
Indications for the use of Saizen® are such cytogenetic disorders as insufficient production or complete absence of secretion of growth hormone in childhood, incomplete development of the sex glands. These pathologies are associated with mutation of certain genes, which lead to underdevelopment of the pituitary gland.
Saizen® is used to treat growth retardation in girls ( gonadal dysgenesis or Turner syndrome ); insufficient growth in prepubertal children caused by chronic renal failure; growth disorders in short children over 4 years of age (with the standard deviation index (SDS) of existing height < -2.5 and taking into account the height of parents SDS < -1).
The drug can also be used in replacement therapy in adults with severe growth hormone deficiency.
Release form
Saizen® is available as a lyophilisate - a biologically active dry powder for the preparation of a solution for subcutaneous injections. The vial for the preparation of an injection solution contains somatropin (8 mg) complete with a solvent (0.3% metacrisol solution) in cartridges and a device for administering the solution "click easy".
Pharmacodynamics
Saizen® contains recombinant human growth hormone (r-LHR), which stimulates protein synthesis and prevents its breakdown (catabolism), thereby affecting growth and body composition. The pharmacodynamics of Saizen® is based on the interaction of the hormone with specific receptors of muscle cells (myocytes), liver cells (hepatocytes), fat cells (adipocytes), lymphocytes and hematopoietic cells of the bone marrow.
The drug helps to increase the level of peptide hormones of the hypothalamus (somatostatin and somatoliberin), which are secreted by neurosecretory cells of the hypothalamus into the portal veins of the pituitary gland and act on the cells releasing the growth hormone (somatotropes). This causes acceleration of growth (mainly due to the growth of long tubular bones of the limbs), helps to normalize carbohydrate metabolism - increased burning of subcutaneous fat and reduced its deposition.
At the same time, the blood glucose level (glycemia) and the level of endogenous insulin secretion (C-peptide) remain within the physiological norm and can increase significantly only in the case of high doses of the drug (20 mg).
In addition, somatotropin has an immunostimulating effect on the growth of most internal organs and has a modulating effect on some functions of the central nervous system.
Pharmacokinetics
After the administration of Saizen®, the maximum concentration of the active substance in the blood serum is reached after 4 hours, after which the somatotropin content in the serum returns to the base level within 24 hours. This indicates the absence of cumulation, i.e. the hormone does not accumulate upon repeated administration.
After intramuscular administration, the maximum hormone content in the blood plasma is reached after 3 hours, and with subcutaneous injection - after 4-6 hours.
The absolute bioavailability of the drug after intramuscular and subcutaneous administration is at least 70-90%.
Dosing and administration
Hormonal therapy is only carried out under systematic medical supervision, since non-androgenic steroids can cause an additional increase in growth rate.
Method of administration and dosage of Saizen®: the drug should be dissolved in a bacteriostatic solvent, which is included in the package. The usual weekly dosage of the drug for intramuscular or subcutaneous administration is 0.6-0.8 IU/kg. For intramuscular administration, this dose is divided into three single injections, for subcutaneous administration - into 6-7 single injections. In the second year of treatment with Saizen®, the weekly dosage can be increased, but not more than to 1 IU/kg.
Therapy for growth hormone deficiency in adult or overweight patients may require individual dosage adjustments towards lower dosages. Experience in treating patients over 60 years of age and long-term use of the drug is limited.
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Use Saizen during pregnancy
The use of Saizen® during pregnancy and lactation is not recommended.
Contraindications
The use of Saizen® is contraindicated in children with pineal gland closure (epiphysis), hypersensitivity to somatropin or another component of the drug, as well as in the presence of active (progression or relapse) neoplasms of the brain. The drug is not used in acute conditions that developed after surgery on the abdominal cavity or heart, as well as in multiple injuries and respiratory failure.
The use of Saizen® may reduce glucose tolerance, as the somatotropin it contains can cause excess sugar in the blood (insulin resistance). Therefore, this drug should be used with caution in patients with diabetes mellitus or a family history of this disease.
Side effects Saizen
Side effects of this drug include: allergic reaction (with the formation of antibodies to Saizen); pain, loss of sensitivity, redness and swelling at the injection site.
To prevent atrophy of fatty tissue in certain areas or regions of the body (local lipoatrophy), subcutaneous injection sites should be changed daily. During therapy, thyroid function may decrease (hypothyroidism), which should be eliminated by administering thyroid hormones (triiodothyronine, thyroxine, thyroglobulin).
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Overdose
An overdose of Saizen® is expressed as a decrease in the normal level of glucose in the blood
(hypoglycemia), which is replaced by increased blood sugar (hyperglycemia). In case of overdose of the drug over a long period of time, signs of acromegaly may be observed - disturbances in the proportions of the skeleton, soft tissues and internal organs (enlargement of facial features, increase in the size of the feet and hands).
Interactions with other drugs
Sensitivity to Saizen® may be suppressed by concomitant treatment with glucocorticoid drugs (prednisolone, etc.). Concomitant therapy with concomitant use of corticosteroids (hydrocortisone, etc.) may completely neutralize the therapeutic effect of Saizen®. During a course of therapy with Saizen®, it is necessary to monitor the level of cortisol in the blood serum to adjust the dose of corticosteroids.
Storage conditions
Shelf life
The shelf life of Saizen® is 3 years from the date of manufacture indicated on the packaging.
Attention!
To simplify the perception of information, this instruction for use of the drug "Saizen" translated and presented in a special form on the basis of the official instructions for medical use of the drug. Before use read the annotation that came directly to medicines.
Description provided for informational purposes and is not a guide to self-healing. The need for this drug, the purpose of the treatment regimen, methods and dose of the drug is determined solely by the attending physician. Self-medication is dangerous for your health.