Testobolin – complete information on the preparation: official instructions, price in the nearest pharmacies for Testobolin, a list of analogues. Indications for use, method of use, side effects, contraindications, pregnancy. The average price is 176.93 UAH. 91 pharmacy prices reported.
- active ingredient: somatropin;
- 1 vial of the drug contains recombinant human Testosterone Enanthate 1.3 mg (4 IU) or 2.6 mg (8 IU);
- excipients: mannitol, glycine, sodium dihydrogen phosphate, disodium phosphate;
- solvent: metacresol, water for injection.
Dosage form. Lyophilisate for injection solution complete with solvent.
Main physicochemical properties: the preparation is a powder of white or almost white color; the solvent is a clear, colorless or slightly yellowish liquid.
Pharmacotherapeutic group. Hormones of the anterior part of the pituitary gland and their analogues. Testosterone Enanthate and Testosterone Enanthate agonists. Testosterone Enanthate ATH code H01A C01.
Pharmacological properties Pharmacodynamics.
Testosterone Enanthate is a strong metabolic hormone that plays an important role in the metabolism of lipids, carbohydrates and proteins. In children with endogenous insufficiency, Testobolin Testosterone Enanthate accelerates linear skeletal growth and growth rate. In both adults and children, Testosterone Enanthate supports normal body structure due to increased nitrogen absorption, accelerated growth of skeletal muscles and mobilization of body fat. Visceral adipose tissue is particularly sensitive to Testosterone Enanthate. In addition to stimulating lipolysis, Testosterone Enanthate reduces the flow of triglycerides to fat depots. The concentrations of IGF-1 (insulin-like growth factor, type 1) and IFRSB-3 (binding protein of insulin-like growth factor, type 3) in the serum are increased under the influence of Testosterone Enanthate.
Lipid metabolism. Testosterone Enanthate stimulates low-density lipoprotein cholesterol receptors (LDL) in the liver and affects the serum lipid and lipoprotein profile. In general, the use of Testosterone Enanthate in patients with Testobolin deficiency leads to a decrease in the concentration of LDL and apolipoprotein B. It is also possible to reduce the level of total cholesterol.
Carbohydrate metabolism. Testosterone Enanthate increases insulin levels, but fasting glucose does not usually change. Children with hypopituitarism may experience fasting hypoglycemia. Stanoprime inverts this state.
Water-salt metabolism. Testobolin deficiency is associated with a decrease in blood plasma and tissue fluid. Both of these indicators are growing rapidly after treatment with Testosterone Enanthate. Testosterone Enanthate contributes to the delay in the body of sodium, potassium and phosphorus.
Bone metabolism. Testosterone Enanthate stimulates skeletal bone renewal. In patients with Testobolin deficiency and osteoporosis, long-term treatment with Testosterone Enanthate leads to an increase in the mineral composition and bone density in the supporting areas.
Physical performance. Long-term treatment with Testosterone Enanthate increases muscle strength and physical endurance. Trenbolin also increases cardiac output, but the mechanism of this effect has not yet been elucidated. A reduction in peripheral vascular resistance may play a role in this.
Data on the safety of long-term use of the drug is still limited.
Absorption. The absolute bioavailability of Testosterone Enanthate, administered subcutaneously, is approximately 80%. The maximum concentration in the blood is reached after 3-6 hours.
Inference. After subcutaneous administration, the half-life may be up to 2-3 hours.
Subpopulations. Bioavailability Testosterone Enanthateu subcutaneous administration is the same in males and females.
Information on the pharmacokinetics of Testosterone Enanthate in elderly patients, children, patients of different races and in patients with impaired renal function and liver or heart failure is missing or incomplete.
- Dysplasia with insufficient secretion of Testobolin (Testobolin deficiency (GDR);
- Dysplasia associated with Shereshevsky-Turner syndrome or chronic renal failure.
Growth impairment (standard deviation (GUS) of the current height is less than2.5 and the standard deviation of genetically determined growth is less than1) in low birth children with a height below the age norm born with a mass and / or body length less than2 standard deviations that could not reach the age norm of growth (the value of the standard deviation of the growth rate is less than 0 during the last year) before they reach 4 years or more.
Growth disorder in Prader-Willi syndrome, with the aim of improving the growth and structure of the body. The diagnosis of Prader-Willi syndrome should be confirmed by appropriate genetic tests.
Replacement therapy for adults with severe Testobolin deficiency.
The occurrence of Testobolin deficiency in adulthood. Patients with Testobolin deficiency are severely associated with multiple hormonal deficiencies due to the known pathology of the hypothalamus or pituitary, as well as patients who are deficient in at least one of the pituitary hormones, with the exception of prolactin. Such patients should be given an appropriate dynamic test to establish the presence or absence of Testobolin deficiency.
For patients whose growth factor deficiency occurred in childhood (as a result of congenital, genetic, acquired or idiopathic causes), the possibility of producing Testobolin after the end of longitudinal growth should be re-evaluated. For patients with a high probability of persistent DGR, for example, with congenital or secondary DGR due to hypothalamic-pituitary disease or stroke, HUS insulin-like growth factor (IGF-I).
Contraindications Increased sensitivity to the active substance or to any excipient.
Testosterone Enanthate is prohibited to prescribe if there are any signs of tumor activity. Intracranial tumors must be inactive, and antitumor therapy must also be completed before the growth hormone therapy begins. If there is any evidence of tumor growth, treatment should be discontinued.
Testobolin should not be used to stimulate growth in children with closed epiphyseal growth zones.
Treatment with Testobolin is contraindicated in patients who are in acute critical condition as a result of complications of open heart surgery, in the abdominal cavity, as a result of multiple trauma, acute respiratory failure or other similar conditions (for information on patients receiving substitution treatment, see Features application “).
Testosterone Enanthate is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
Testosterone Enanthate is contraindicated in children with Prader-Willi syndrome, severe obesity or severe respiratory problems.
In children with chronic kidney disease, treatment with Testosterone Enanthate should be discontinued during kidney transplantation.
Interaction with other drugs and other types of interactions.
Simultaneous use with glucocorticosteroids (GCS) can suppress the stimulating effect of Testosterone Enanthate drugs on the growth rate. Therefore, it is necessary to carefully monitor the growth of patients receiving GCS treatment in order to be able to assess the potential effect of glucocorticoid use on growth.
Testobolin reduces the conversion of cortisone to cortisol and may reveal a previously undiagnosed central hypoadrenalism or make low doses of glucocorticoids ineffective during replacement therapy.
Testosterone Enanthate is an inducer of cytochrome P450 (CYP) activity, which can lead to a decrease in plasma concentration and, accordingly, to a decrease in the effectiveness of drugs that are metabolized with cytochrome CYP3A, for example, sex hormones, corticosteroids, cyclosporine and anticonvulsants.
For more information on diabetes and thyroid dysfunction, see the section Application Features, and on oral estrogen replacement therapy, see the section Dosage and Administration.
Features of the applicationStep the diagnosis, start therapy with COMATIN and follow up monitoring should be carried out by qualified doctors with experience in the diagnosis and treatment of patients in accordance with the indications for use.
Myositis is a very rare side effect that can be caused by the action of the preservative metacresol, which is part of the drug. In the case of myalgia or increased pain at the injection site, the occurrence of myositis should be assumed. If it is confirmed, the form of the drug Testosterone Enanthate that does not contain metacresol should be used.
Do not exceed the maximum recommended daily dose (see section “Dosage and administration”).
Testobolin Insulin sensitivity
Testosterone Enanthate may decrease insulin sensitivity. For patients with diabetes after initiation of Testosterone Enanthate therapy, insulin dosage adjustment may be required. During Testosterone Enanthate therapy, the condition of patients with diabetes mellitus, glucose intolerance or additional risk factors for the development of diabetes mellitus should be monitored. In rare cases, Testosterone Enanthate therapy may cause significant glucose intolerance, which meets the diagnostic criteria for type 2 diabetes.
The risk of developing diabetes mellitus during treatment with Testosterone Enanthate is higher in patients with other risk factors for the onset of type 2 diabetes, such as obesity, diabetes mellitus in the family history, treatment with steroids, or pre-reduced glucose tolerance. In patients with existing diabetes mellitus, the dosage of anti-diabetic therapy may require correction after the appointment of Testosterone Enanthate therapy.
Thyroid function of Testobolin
Testobolin accelerates the peripheral conversion of T4 to T3, which can lead to a decrease in serum T4 and an increase in serum T3. While peripheral concentrations of thyroid hormones remain normal in most healthy volunteers, it is theoretically possible for hypothyroidism to develop in patients with a subclinical form of hypothyroidism. Therefore, thyroid function should be monitored in all patients. In patients with hypopituitarism who receive standard replacement therapy, it is necessary to carefully control the possible effect of growth hormone therapy on thyroid function.
In the case of a secondary Testobolin deficiency due to the treatment of malignant diseases, it is recommended to pay attention to the signs of recurrence of a malignant neoplasm. In relation to persons with advanced malignant neoplasms in childhood, an increased risk of the development of a secondary neoplasm was reported in patients treated with Testosterone Enanthate after the primary neoplasm. Most often, such secondary tumors in patients receiving radiotherapy in the head area for primary neoplasm were intracranial tumors, in particular meningiomas.
Patients with endocrine disorders, particularly Testobolin deficiencies, may experience hip-head dislocations more often than in the general population. Children limping during Testosterone Enanthate therapy should be clinically examined.
Treatment with Testosterone Enanthate can lead to inhibition of 11ЮВHSD-1 and a decrease in serum cortisol concentration. In patients treated with Testosterone Enanthate, a previously undiagnosed central (secondary) hypoadrenalism can be detected, and they may need to be replaced with GCS. In addition, patients who received glucocorticoids as a replacement therapy for previously diagnosed hypoadrenalism may require an increase in supportive or shock doses after starting treatment with Testosterone Enanthate.
Testobolin Use with Oral Estrogen
If a woman who is taking Testosterone Enanthate starts oral estrogen therapy, then you may need to increase the dose of Testosterone Enanthate to maintain serum IGF-1 levels within the age norm. Conversely, if a woman is taking Testosterone Enanthate, stops therapy with oral estrogen, then you may need to reduce the dose of Testosterone Enanthate to avoid an excess of Testobolin and / or side effects.
Benign intracranial hypertension
In case of severe or frequent headache, visual impairment, nausea and / or vomiting, an ophthalmoscopy is recommended to detect optic nerve edema. If the presence of optic nerve edema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if necessary, discontinued treatment with growth hormone. Currently, there is insufficient information on the basis of which recommendations can be formulated regarding the continuation of growth hormone therapy for patients after the elimination of intracranial hypertension. After the resumption of growth hormone therapy, it is necessary to carefully monitor for the appearance of symptoms of intracranial hypertension.
Cases of leukemia have been reported in a small number of patients with Testobolin deficiency, some of whom received Testosterone Enanthate therapy. However, there is no evidence of an increase in the incidence of leukemia in patients receiving Testobolin and who are not prone to this disease.
In a small proportion of patients, antibodies to the preparation COMATIN may be formed. These antibodies are characterized by weak binding ability and do not affect the growth rate. Any patient with an insufficient response to treatment (which cannot be explained by other reasons) should be tested for the presence of antibodies to Testosterone Enanthate.
Experience with patients aged 80 years is limited. Elderly patients may be more sensitive to the action of the drug, and therefore more likely to develop adverse reactions.
Acute Critical Conditions
Since there is no information about the safety of growth hormone replacement therapy in patients with acute critical conditions, for this situation it is necessary to compare the benefits of continuing treatment and potential risks.
For all patients who have a different or similar acute critical condition, it is necessary to compare the perceived benefit of treatment with COMATIN and the potential risk.
There are isolated cases of pancreatitis in children and adults treated with Testosterone Enanthate, with some evidence of a higher risk in children than adults. There is evidence that girls with Shereshevsky Turner syndrome are at greater risk than other children who were treated with Testosterone Enanthate. In any patient treated with Testosterone Enanthate, especially in children with progressive, persistent severe abdominal pain, it is necessary to consider the possibility of pancreatitis.
In patients with Prader-Willi syndrome, treatment should always be combined with a low-calorie diet.
Lethal effects were reported associated with the use of Testobolin in children with Prader-Willi syndrome who had one or more risk factors: severe obesity (patients with a weight-to-height ratio that exceeds 200%), a history of respiratory failure or apnea during sleep or unidentified respiratory infection. Patients with one or more of these factors may be at increased risk.
Patients with Prader-Willi syndrome should be checked for signs of upper airway obstruction, sleep apnea, or respiratory infections before starting Testosterone Enanthate treatment.
If, when assessing the patency of the upper respiratory tract, data on the presence of pathology are obtained, the child should be referred to an otolaryngologist for treatment and elimination of respiratory disorder before the start of treatment with growth hormone.
The presence of sleep apnea should be checked prior to the initiation of growth hormone therapy using standard polysomnography or nighttime oximetry and should be monitored if it can develop.
If during treatment with Testosterone Enanthate, patients experience symptoms of obstruction of the upper respiratory tract (including the appearance and increase in snoring), treatment should be interrupted and a new examination of the upper respiratory tract should be conducted.
If sleep apnea can develop during sleep, all patients with Prader-Willi syndrome should be monitored.
Patients should identify signs of respiratory infections that need to be diagnosed as early as possible and actively treated.
In all patients with Prader-Willi syndrome, body weight should also be carefully monitored before and during growth hormone treatment.
Patients with Prader-Willi syndrome often develop scoliosis. In some children, due to rapid growth, scoliosis may progress. During treatment, signs of scoliosis should be monitored.
The long-term experience with Testobolin for the treatment of adults and patients with Prader-Willi syndrome is limited.
Low born children
Before treatment is started, low birth-born babies with a height below the norm for their gestational age should exclude the possibility of the influence of other medical causes or remedies on growth impairment.
Before starting treatment of low-born babies born with a growth below the norm for their gestational age, it is recommended to determine fasting insulin levels and fasting blood glucose and repeat this study every year. Patients with a high risk of diabetes (for example, in the presence of a family history of diabetes, obesity, severe insulin resistance, black acanthosis) should be given an oral glucose tolerance test. If diabetes is diagnosed, Testobolin should not be used.
Before starting treatment, low birth-born babies with a growth below the normal for their gestational age are recommended to measure IGF-1 levels and repeat this study twice a year. If, after repeated measurements, the standard deviation of IGF-1 levels exceeds +2 VSO compared with the age norm and puberty, then the IGF-1 / IFRS-3 ratio should be taken into account in order to decide whether to correct the dose.
The experience of treatment immediately before the onset of puberty is low from the birth of children born with low body mass is limited. Therefore, it is not recommended to start treatment immediately before puberty. Experience in treating patients with Silver-Russell syndrome is limited.
The advances made in treating low-born growth hormone can be lost if treatment is stopped before they reach their final height.
Chronic renal failure
In the case of chronic renal failure, renal function before treatment should be less than 50% of the norm. To confirm signs of dysplasia, growth should be monitored throughout the year prior to initiation of therapy. During this period, conservative treatment of renal dysfunction (including control of acidosis, hyperparathyroidism and nutrition) should be initiated and carried out during growth hormone therapy. Treatment should be discontinued in the event of a kidney transplant.
At present, there are no data on the achievement of final growth in patients with chronic renal dysfunction, for the treatment of which Testosterone Enanthate was used.
Patients with existing tumors or Testobolin deficiency, arising from intracranial lesions, should be regularly examined for progression or recurrence of the underlying pathological process. In children, no link was found between Testosterone Enanthate replacement therapy and central nervous system (CNS) tumor recurrence or the emergence of new extracranial tumors. However, among the surviving children with cancer, an increased risk of a second neoplasm was reported in patients who received Testosterone Enanthate after treatment of the first neoplasm. Intracranial tumors, in particular meningiomas, are the most common secondary neoplasms in patients undergoing treatment with irradiation of the head during the treatment of the first neoplasm.
It is not known whether there is a link between Testosterone Enanthate replacement therapy and CNS tumor recurrence in adult patients.
Patients should be carefully monitored for any malignant transformation of skin lesions.
Replacement therapy should be carefully monitored in patients with hypopituitarism during treatment with Testosterone Enanthate.
Dislocation of the femoral head in children
Dislocation of the femoral head often occurs in patients with endocrine disorders (including DGR and Shereshevsky Turner syndrome) or in fast-growing patients. Any pediatric patient who began to limp or complain of pain in the hip or knee joint during Testosterone Enanthate therapy should be carefully examined.
Otitis and cardiovascular disorders in patients with Shereshevsky-Turner syndrome
Patients with Shereshevsky Turner syndrome should be carefully evaluated for the occurrence of otitis media and other ear diseases, since these patients have an increased risk of developing such diseases and hearing disorders. Treatment with Testosterone Enanthate can lead to an increased risk of otitis media in patients with Shereshevsky Turner syndrome. In addition, in patients with Shereshevsky Turner syndrome, the state of the cardiovascular system must be carefully monitored, since such patients have an increased risk of cardiovascular diseases such as stroke, aneurysm / aortic dissection, and hypertension.
Systemic and local reactions
With the introduction of Testosterone Enanthate subcutaneously in the same place for a long time, tissue atrophy may occur.
As with any protein, local or systemic allergic reactions can occur. Parents / patients should be informed that such reactions are possible and prompt medical intervention is necessary in the event of an allergic reaction.
Changes in laboratory parameters
During therapy with Testosterone Enanthate in serum, the level of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH) and insulin-like growth factor (IFR-I) may increase.
Use during pregnancy or lactation. Clinical studies of the use of Testosterone Enanthate drugs during pregnancy are absent. Therefore, drugs containing Testosterone Enanthate are not recommended for pregnant women and women of reproductive age who do not use contraception.
Clinical studies of the use of drugs Testosterone Enanthate during the period of breastfeeding were not conducted. It is not known whether Testosterone Enanthate penetrates into breast milk, but absorption of intact protein from the infant gastrointestinal tract is extremely unlikely. Testosterone Enanthate drugs should be used with caution in breastfeeding women.
The ability to influence the reaction rate when driving vehicles or other mechanisms.
Testobolin does not affect the reaction rate when driving vehicles or other mechanisms.
Dosage and administration: Stage diagnosis, start therapy with COMATIN and follow up monitoring should be carried out by qualified doctors with experience in diagnosing and treating patients in accordance with the indications for use.
The dosage and mode of use should be selected individually, taking into account the severity of Testobolin deficiency, weight or surface area of the patient, and effectiveness in the treatment process.
The injection should be carried out subcutaneously, slowly, as a rule, in the evening and change the place of administration to prevent lipoatrophy.
Growth retardation due to insufficient secretion of Testobolin in children. Usually the recommended dose is 0.025-0.035 mg / kg body weight (0.07-0.1 IU / kg) per day or 0.7-1.0 mg / m2 of body surface area (2.1-3.0 IU / m2) per day. Treatment begins as soon as possible at an earlier age and continues until the growth rate decreases with treatment up to 2 cm / year or less, until the growth zones close, achieve socially acceptable growth (155-160 cm for girls, 165-170 cm for boys) or attaining bone age in girls 14-15 years old, in boys 16-17 years old.
If Testobolin deficiency occurred in childhood and persists during adolescence, treatment should continue until full physical development (i.e., body structure, bone mass) is achieved. To control the achievement of a normal peak, bone mass is defined as T>1 (standardization to the average peak of the adult bone mass measured using dual-energy x-ray absorptiometry taking into account gender and ethnicity), which is one of the therapeutic goals during the transition period.
Prader-Willi syndrome, with the aim of improving growth and build in children. Typically, 0.035 mg / kg of body weight per day or 1.0 mg / m2 of body surface area is prescribed. The daily dose of 2.7 mg should not be exceeded. Testobolin should not be used in children with a growth rate of less than 1 cm per year and at the age when the closing of the epiphyseal growth zones begins.
Growth retardation due to Shereshevsky Turner syndrome. The recommended dose is 0.045-0.05 mg / kg body weight (0.14 IU / kg) or 1.4 mg / m2 (4.3 IU / m2) of body surface area per day.
Growth retardation in patients with chronic renal failure. The recommended dose is 0.045-0.05 mg / kg body weight (0.14 IU / kg) or 1.4 mg / m2 (4.3 IU / m2) of body surface area per day. Insufficient growth rate may require a higher dose. Dose adjustment may be required after 6 months of treatment.
Growth retardation in low-born children. Usually, the recommended dose is 0.035 mg / kg body weight per day (1 mg / m2 body surface per day) until the final growth is achieved.
Treatment should be discontinued after the first year if the standard deviation of the growth rate is less than +1. Treatment should be discontinued if the growth rate is less than 2 cm per year and (if it is necessary to confirm) the bone age is more than 14 years for girls or more than 16 years for boys, corresponds to the age of closure of germ zones in the epiphysis of bones.