Index of drugs

Children. Growth disturbance associated with insufficient secretion of growth hormone, Turner syndrome or chronic renal failure. Growth disturbance (current increase below -2.5 SD and an increase standardized by parental increase below -1 SD) in children with intrauterine growth delay (SGA), birth weight and / or birth length below -2 SD, who did not recover from growth deficit ( HV SD below 0 in the last year) up to 4 years of age or later. Prader-Willi syndrome to increase growth and improve body composition (reduction of fat mass). Diagnosis of the Prader-Willi syndrome should be confirmed by appropriate genetic tests.Adults. Replacement therapy in adults with a marked deficiency of growth hormone. Severe growth hormone deficiency in adults is defined by the established hypothalamic pituitary pathology and the found deficiency of at least one pituitary hormone, other than prolactin; one dynamic diagnostic test should be performed to diagnose or rule out growth hormone deficiency. In patients with isolated GH deficiency diagnosed in childhood (no evidence of hypothalamic pituitary pathology and no history of radiotherapy), two dynamic tests are recommended, except for patients with low levels of IGF-I (> 2 SD), who may be considered performing only one test. The criteria for evaluating the dynamic test result must be strictly adhered to.

1 ml solution for injection contains either 5.3 mg or 12 mg somatropin.

Human growth hormone produced in cellsE. coli, obtained by recombinant DNA technology. Somatropin is a metabolic hormone, it participates in the metabolism of fats, carbohydrates and proteins. In children with endogenous growth hormone deficiency, somatropin stimulates linear growth and, as a result, accelerates growth. In adults as well as in children, somatropin supports normal body structure, maintains a positive nitrogen balance and stimulates skeletal muscle growth, as well as accelerates fat metabolism in the body. Organ fat tissue is particularly sensitive to somatropin. The bioavailability of subcutaneously administered somatropin is about 80%, both in healthy people and in the case of growth hormone deficiency. The maximum concentration in the blood is reached after 3-6 h. T_0,5 after subcutaneous administration it is 2-3 hours.

Hypersensitivity to the preparation ingredients (including m-cresol). It should not be administered in case of any symptoms of neoplastic disease (anti-cancer treatment should be stopped before starting the treatment). Do not give to children who have closed the growth zones of the long bones. It should not be used in acute life-threatening conditions, in patients with complications after open heart surgery, after abdominal surgery, multi-organ trauma and in patients with acute respiratory failure.

Somatropin may induce a state of insulin resistance, in some patients hyperglycaemia (patients should be monitored for signs of Glucose intolerance, patients with overt diabetes may need to change the dosage of antidiabetic agents). During treatment with somatropin, the increase in peripheral thyroxine conversion was found (T₄) to triiodothyronine (T.₃) - this may result in a decrease in the concentration of thyroxine with a simultaneous increase in the amount of triiodothyronine in the blood. In patients with hypothalamic hypothalamic hypothyroidism, theoretically there may be overt hypothyroidism. On the other hand, hyperthyroidism may occur in patients treated with thyroxine due to hypothyroidism. Therefore, after starting treatment with somatropin and after adjusting the dose, thyroid function should be checked. In the secondary deficiency of growth hormone caused by cancer, attention should be paid to possible symptoms of tumor recurrence.During treatment with somatropin, limping children should be thoroughly examined (in patients with endocrine gland dysfunction, dysplasia of the proximal femur is more common). If mild intracranial hypertension is diagnosed, GH should be discontinued; if the growth hormone administration is resumed, close observation of patients for signs of intracranial hypertension is necessary. There have been reports of deaths associated with the use of GH in children with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, impaired respiratory or history of sleep apnea, or an unidentified respiratory infection. Therefore, patients with Prader-Willi syndrome should be examined for signs of upper airway obstruction, sleep apnea or respiratory tract infection prior to treatment with GH; if any of the above-mentioned conditions are found, appropriate treatment of the disease should be undertaken before the start of GH administration. It is also necessary to closely monitor patients with sleep apnea. If during treatment with somatropin patients develop symptoms of upper airway obstruction (eg, if the snoring appears or gets worse), the treatment should be discontinued and the laryngological diagnosis should be carried out again. All patients with Prader-Willi syndrome should also be monitored for body weight before growth hormone treatment and during treatment. In patients with Prader-Willi syndrome, a low-calorie diet should be used at the same time during treatment with somatropin. During GH therapy, patients with Prader-Willi syndrome should be observed for scoliosis. In children with intrauterine growth retardation, other causes of growth disorders should be ruled out before starting GH therapy. In these children, before starting treatment and every year during treatment, the concentration of insulin and fasting glucose should be measured, in children with an increased risk of diabetes, an oral glucose tolerance test should be performed - patients who have been diagnosed with diabetes should not receive GH. In children with intrauterine growth delay, the IGF-I concentration should be determined before the treatment is implemented, and then twice each year. If consecutive IGF-I results after age and puberty exceed +2 SD, the IGF-I / IGFBP-3 ratio may be considered to adjust the dose of somatropin. Intensification of growth after growth hormone treatment in children with intra-uterine growth delay can be inhibited if the therapy is stopped before reaching the final height. Due to insufficient experience, it is not recommended to start treatment in children with intrauterine growth late in the onset of puberty. There is little experience with the use of GH in patients with Silver-Russel syndrome. The condition for starting treatment with growth hormone in patients with chronic renal failure is a 50% reduction in renal function in relation to the norm. To confirm the growth disorder, the growth rate should be monitored for a year before the start of treatment, during which time the conservative treatment of renal failure (including prevention of acidosis and hyperparathyroidism and the control of the nutritional status) should be established. The established procedure should be maintained during treatment with growth hormone. So far, there is no data regarding the final increase in patients with chronic renal failure resulting from treatment with somatropin. Growth hormone treatment should be terminated when the kidney is transplanted. Clinical data on the use of GH in patients over 60 years are limited. If you have muscular pains or excessive pain at the injection site, you should consider having m-cresol associated muscle inflammation and change the somatropin formulation to a m-cresol-free preparation.

There is no clinical experience with the use of somatropin in pregnant women - it is not recommended for pregnant women and women of childbearing age not using effective contraception. It has not been established whether somatropin is excreted in breast milk. Absorption of unchanged protein from the infant's digestive tract is unlikely.

Common: production of antibodies against somatropin; in addition, in adults - paresthesia, stiffness of limb joints, pain in the joints and muscles, peripheral edema; in children - transient local skin reactions at the application site. Uncommon: in adults - carpal tunnel syndrome; in children - paresthesia, stiffness of limb joints, pain in the joints and muscles, peripheral edema. Rare: type 2 diabetes, benign intracranial hypertension. Very rare: leukemia and myositis caused by the m-cresol preservative. It has also been found that somatropin lowers blood cortisol levels, possibly affecting transport proteins or increasing hepatic cortisol clearance. There have been rare reports of sudden deaths of patients with Prader-Willi syndrome who have been treated with somatropin.

Diagnosis and treatment with the product should be carried out by physicians with appropriate qualifications and experience in the diagnosis and treatment of patients with indications for the use of the drug. Subcutaneously (injection sites should be changed to reduce the risk of lipodystrophy).Children. Growth hormone deficiency: 0.025 - 0.035 mg / kg / day or 0.7 - 1 mg / m² pc./dobę; the dose can be increased if necessary.Prader-Willi syndrome: 0.035 mg / kg / day or 1 mg / m² pc./dobę; the maximum dose is 2.7 mg / m² pc./dobę; drug should not be used in children who grow less than 1 cm per year or with nearly closed growth zones of the epiphysis bones.Turner's team: 0.045 - 0.05 mg / kg / day or 1.4 mg / m² pc./dobę.Growth deficiency in chronic renal failure: 1.4 mg / m² pc / day, corresponding to approximately 0.045 - 0.05 mg / kg / day; the dose can be increased if the rate of growth of the patient is unsatisfactory; after the half-year period of treatment, the dosage may need to be modified.Intrauterine growth delay (SGA): 0.035 mg / kg / day or 1 mg / m² pc / day until the final height is reached; treatment should be discontinued after a year if the growth rate is less than +1 SD; treatment should also be discontinued if the growth rate is less than 2 cm / year and if, if confirmation is necessary, bone age is above 14 years (girls) or above 16 years (boys).Adults. Growth hormone deficiency: the initial dose is 0.15-0.3 mg / day, the dose should be gradually increased depending on individual needs, determined on the basis of the determination of serum IGF-I concentration. One should strive to obtain IGF-I concentration in the range of 2 SD from the mean value standardized in relation to age. Patients with normal IGF-I levels at the time of initiation of therapy should be given growth hormone up to the upper limit of the normal range, without exceeding 2 SD. The maintenance dose is usually not more than 1 mg / day. Women may require higher doses (especially those using HRT) than men who have an increased sensitivity to IGF-I over time. In adults, every six months, the dosage should be modified. With age, the need for somatropin may be reduced. In any case, the lowest effective dose of somatropin should be used.