Omnitrop - instructions for use, reviews, analogs and release forms (solution for subcutaneous administration of 3.3 mg and 6.7 mg per ml in a syringe pen or injector with a cartridge) of the drug for the treatment of growth retardation in adults, children and in pregnancy

In this article, you can read the instructions for using the drug Omnitrop. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Omnitrop in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Omnitrops in the presence of existing structural analogues. Use to treat growth retardation and chronic renal failure in adults, children, as well as during pregnancy and lactation.

Omnitrop - a drug that exerts a pronounced effect on the metabolism of fats, proteins and carbohydrates. In children with a deficiency of growth hormone somatropin (the active substance of the drug Omnithrop) stimulates the growth of the bones of the skeleton in length, affecting the plates of the epiphysis of tubular bones. In both adults and children, somatropin helps normalize the structure of the body 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 flow of triglycerides into body fat. Under the action of somatropin, the concentration of insulin-like growth factor 1 (IRP-1) and its binding protein (IGF-SB3, insulin-like growth factor binding protein) increases.

Omnitrop activates low-density lipoprotein (LDL) receptors in the liver and changes the profile of lipids and lipoproteins in the blood. In general, the appointment of somatropin to patients with a deficiency of growth hormone leads to a decrease in blood levels of LDL and apolipoprotein B. A decrease in the concentration of cholesterol is also observed.

Somatropin increases the release of insulin, but the fasting glucose concentration usually does not change.Children with hypopituitarism may develop fasting hypoglycemia. This condition is reversible with the administration of somatropin.

Deficiency of growth hormone is associated with a decrease in the volume of plasma and extracellular fluid. The administration of somatropin leads to a rapid increase in both parameters. Somatropin promotes the retention of sodium, potassium and phosphorus.

Omnitrop stimulates bone metabolism. Long-term treatment of children with growth hormone deficiency and osteoporosis with somatropin leads to normalization of mineral composition and bone density.

Long-term substitution therapy with somatropin leads to an increase in muscle strength and physical endurance. Cardiac output is also increased, although the mechanism of this action is not completely clear. Reduction of peripheral vascular resistance, perhaps, partially explains this action of somatropin.

Composition

Somatropin + auxiliary substances.

Pharmacokinetics

After subcutaneous administration, the bioavailability of somatropin is approximately 80% in both healthy individuals and in patients with growth hormone deficiency. Absolute bioavailability of Omnitrops after subcutaneous administration does not differ between men and women.There is no evidence of an effect on age, race, liver, kidney or heart function on the pharmacokinetic parameters of somatropin.

Indications

• growth retardation in children due to inadequate growth hormone secretion;
• Shereshevsky-Turner syndrome, Prader-Willi syndrome (SLE) in children;
• accompanied by delayed growth, a decrease in kidney function by more than 50% in chronic renal failure (CRF) in childhood;
• low for this gestational age of the newborn growth indicators;
• in adults as a substitution therapy with a confirmed expressed congenital or acquired growth hormone deficiency, including hypopituitarism.

Forms of release

A solution for subcutaneous administration of 3.3 mg in 1 ml and 6.7 mg in 1 ml in a 1.5 ml cartridge (syringe pen or injector).

Instructions for use and dosing regimen

Omnitrop is administered subcutaneously, slowly, once a day, usually at night. It is necessary to change the injection site to prevent the development of lipoatrophy. Doses are selected individually, taking into account the severity of growth hormone deficiency, mass or body surface area, the effectiveness in the therapy process.

Children

If there is insufficient secretion of growth hormone, a dose of 0.025-0.035 mg per kg of body weight per day or 0.7-1 mg per 1 m2 of body surface area per day is recommended. Treatment begins as early as possible and continues until puberty and / or until the bone growth zones are closed. It is possible to stop treatment when the desired result is achieved.

With Shereshevsky-Turner syndrome, a dose of 0.045-0.05 mg per kg of body weight per day or 1.4 mg per 1 m2 of body surface area per day is recommended.

With Prader-Willy syndrome, the recommended dose is 0.035 mg per kg of body weight per day or 1 mg per 1 m2 of body surface area per day to increase growth and improve body composition in children. The daily dose of the drug should not exceed 2.7 mg. Treatment should not be given to children who have an increase in growth of less than 1 cm per year and with practically closed epiphyseal bone growth zones.

In chronic renal failure in children accompanied by growth retardation, a dose of 0.045-0.05 mg per kg of body weight per day is recommended. If the growth dynamics are insufficient, higher doses of the drug may be required. Revision of the optimal dose is possible after 6 months of treatment.

If growth is impaired in children born with low growth rates for this gestational age,a dose of 0.035 mg per kg of body weight per day or 1 mg per 1 m2 of body surface area per day is recommended until the desired growth is achieved. Treatment should be discontinued if, after the first year of therapy with the drug, the increase in growth does not exceed 1 cm. The therapy should also be discontinued if the growth increase does not exceed 2 cm per year and based on the condition of epiphyseal growth zones, if necessary, it is confirmed that the bone age more than 14 years (for girls) or more than 16 years (for boys).

Adults

In adults with a pronounced growth hormone deficiency, it is recommended to start substitution therapy with low doses - 0.15-0.3 mg per day, followed by a gradual increase depending on the serum concentration of IGF-1. This indicator should be within 2 deviations from the average for a given age. In patients with normal initial concentration of IGF-1, the dose of the drug should be selected in such a way that the IGF-1 values ​​are at the upper limit of the norm, within the limits of 2 standard deviations from the mean. The maintenance dose is selected individually, but does not exceed, as a rule, 1 mg per day, which corresponds to 3 international units (IU) per day.

Side effect

• peripheral edema;
• stiffness of limbs;
• arthralgia, myalgia (pain in the joints, muscles);
• paresthesia (spontaneous sensations of burning, tingling, crawling);
• leukemia;
• the formation of antibodies to somatropin;
• type 2 diabetes mellitus;
• carpal tunnel syndrome (in adults);
• benign intracranial hypertension;
• transient skin reactions at the injection site (in children).

Contraindications

• malignant neoplasms;
• Urgent conditions (including conditions after operations on the heart, abdominal cavity, acute respiratory failure);
• stimulation of growth in patients with closed epiphyseal growth zones;
• pregnancy;
• the period of breastfeeding (during the period of treatment it is necessary to refuse breastfeeding);
• the period of newborns (including premature babies) due to the presence of benzyl alcohol in the composition;
• hypersensitivity to any component of the drug.

Application in pregnancy and lactation

Contraindicated therapy Omnitropom during pregnancy and lactation (at the time of treatment must abandon breastfeeding).

Use in children

It is used in children according to indications.

Contraindicated in the period of newborns (including premature infants) due to the presence of benzyl alcohol.

PPatients in elderly patients

Experience in people over 60 years of age is limited.

Elderly patients are recommended lower doses.

special instructions

Somatropin can cause insulin resistance, and in some patients - hyperglycemia, so you should first identify the presence of glucose intolerance. In rare cases, the appointment of Omnitrop can develop type 2 diabetes mellitus, however, in the vast majority of these cases, patients had risk factors such as obesity (including obesity with SLE), family history, glucocorticosteroids (glucocorticosteroids) or previous tolerance impairment glucose. In patients with existing diabetes mellitus, when administering somatropin, a dosage adjustment of hypoglycemic drugs may be necessary.

In the treatment with somatropin, increased conversion of thyroxine (T4) to triiodothyronine (T3) has been identified, which can cause a decrease in T4 concentration and an increase in plasma T3 concentration.In healthy volunteers, as a rule, the concentration of thyroid hormones in the blood remained within normal limits. The effect of somatropin on the concentration of thyroid hormones can be of clinical significance in patients with central subclinical hypothyroidism, in whom hypothyroidism can potentially develop. On the other hand, patients receiving thyroxine as hormone replacement therapy may develop hyperthyroidism. Proceeding from this, it is strongly recommended to monitor the function of the thyroid gland after the initiation of somatropin therapy, and also with each change in its dose.

It was noted that somatropin reduces the concentration of cortisol in the plasma, possibly by acting on carrier proteins or by increasing hepatic clearance. The clinical significance of these observations can be limited, however, substitutive glucocorticosteroid therapy prior to Omnitrophe administration should be optimized.

If there is a deficiency of growth hormone, which appeared after antitumor therapy, you should pay attention to possible signs of recurrence of malignant neoplasm.

In patients with endocrine disorders, including growth hormone deficiency, the femoral epiphysis shift may be observed more often than in the general population.

Detection of lameness on the background of somatropin therapy requires clinical examination and careful observation.

In case of severe or recurrent headaches, visual disturbances, nausea and / or vomiting, fundoscopy is recommended (eye examination, by which you can inspect the back of the eyeball called the bottom) in order to diagnose a possible edema of the optic nerve. When confirming the diagnosis, you should evaluate the presence of benign intracranial hypertension and, if necessary, cancel the drug.

To date, there is no clear guidance on the use of growth hormone in patients with corrected intracranial hypertension. Nevertheless, the experience of clinical application indicates that the resumption of treatment with somatropin in many cases does not lead to relapse of intracranial hypertension. If the use of growth hormone has been resumed, careful monitoring of the possible appearance of symptoms of intracranial hypertension is necessary.

In patients with SLE, treatment should necessarily be associated with a calorie-restricted diet.

There have been reports of deaths associated with the use of growth hormone in children with SLE who have at least one of the following risk factors: severe obesity, a history of respiratory failure, nocturnal sleep apnea, or an unidentified respiratory infection. Patients with SLE in the presence of one or more of the listed factors may have a greater risk.

Patients with Prader-Willi syndrome should be examined for obstruction of the upper respiratory tract, nighttime apnea and respiratory infections before commencing somatropin. If there is an obstruction of the upper respiratory tract, it must be skillfully suppressed before starting the use of somatropin.

Diagnosis of nocturnal sleep apnea is performed before the beginning of the drug using approved methods such as polysomnography or night oximetry, and if suspicion of this syndrome occurs, careful monitoring should be carried out. If during the treatment with somatropin there are signs of obstruction of the upper respiratory tract (including the appearance or strengthening of snoring),treatment should be interrupted and an unplanned otolaryngological examination should be conducted.

All patients with SLE should be observed for an overnight apnea, and, if suspected, their condition should be monitored. In addition, all patients with SLE should monitor the occurrence of respiratory infections, diagnose them as early as possible, and carry out massive antimicrobial therapy. All patients with SLE should actively monitor their body weight both before and during somatropin.

Scoliosis - a frequent phenomenon in SLE, it can progress in any child with rapid growth of the body. Therefore, during treatment with somatropin it is necessary to monitor possible signs of scoliosis. Despite this, the use of growth hormone does not increase the likelihood of development or severity of scoliosis.

Long-term experience in adults and patients with SLE is limited.

In children and adolescents with growth deficiency and low weight for gestational age at birth (MWGV), other causes of growth insufficiency and the possibility of using other methods of treatment should be evaluated before starting therapy with somatropin.

In children and adolescents with WBG it is recommended to measure the concentration of insulin and blood glucose on an empty stomach before the start of therapy and then annually. In patients with an increased risk of developing diabetes (a family history of diabetes, obesity, severe insulin resistance, acanthokeratoderma - blue-black skin syndrome), a glucose tolerance test should be performed. With the obvious symptoms of diabetes, the use of growth hormone is not allowed.

In children and adolescents with WBG it is recommended to measure the concentration of IRF-1 before treatment and 2 times a year after its onset. If in repeated measurements the concentration of IGF-1 exceeds +2 standard deviations relative to the typical values ​​for a given age and the degree of sexual development, then the ratio of concentrations of IGF-1 to IRF-SB3 should be taken into account for correcting the dose of somatropin.

The experience of therapy in patients with MWVB during puberty is limited, so it is not recommended to start treatment during this period.

The use in patients with the syndrome of Silver-Russell is also limited.

When treating children and adolescents with WBV, one should keep in mind that when therapy is stopped before reaching the maximum possible growth, some of the increase in growth may be lost.

With CRF, the functional activity of the kidneys before the initiation of therapy should be less than 50% of normal. To confirm the violation of growth, it is necessary to monitor growth in dynamics during the year preceding therapy. During this period, a conservative treatment is prescribed, including control of acidosis, hyperparathyroidism, and nutritional status. This treatment continues with the beginning of the main therapy.

When kidney transplantation treatment should be discontinued.

At present, there is no data on the magnitude of the growth increment when Omnitrop is prescribed for patients with CRF.

The reparative effects of somatropin in adult patients critically ill due to complications after open-heart and abdominal operations, multiple accidental injuries, and acute respiratory failure were evaluated in two placebo-controlled studies. Mortality in patients who were prescribed 5.3 mg or 8 mg of somatropine per day was higher than in the placebo group (42% and 19%, respectively). According to these results, the listed patient groups should not be prescribed somatropin.Since the safety of the appointment of growth hormone in patients in acute critical condition is unknown, the intended benefit from the appointment should be correlated with the possible risk in such patients.

It is necessary to change the places of hypodermic injections in connection with the possibility of lipoatrophy development.

This preparation contains less than 1 mmol sodium (23 mg) per 1 ml, which is a negligible amount.

Since benzitric alcohol is present in the Omnitrop, so it should not be given to premature infants or newborns, as this component can cause toxic and anaphylactic reactions in children under 3 years of age.

Drug Interactions

The results of the study of drug interaction in adult patients with growth hormone deficiency suggest that the appointment of somatropin increases the clearance of drugs metabolized by microsomal isoenzymes of cytochrome P450 in the liver, especially those metabolized by the isoenzyme 3A4 - sex hormones, glucocorticosteroids, anticonvulsants and cyclosporine, which can lead to a decrease in their concentration in the plasma.The clinical significance of this effect has not yet been determined.

GCS inhibits the stimulating effect of somatropin on growth processes.

The effectiveness of the drug (in terms of final growth) may also be affected by concomitant therapy with other hormones, for example, gonadotropin, anabolic steroids, estrogens and thyroid hormones.

Analogues of the drug Omnithrop

Structural analogs for the active substance:

• The biosome;
• Genotropin;
• Gentropine;
• Dinatrop;
• Norditropin;
• Rastan;
• Sizen;
• Somatropin;
• Humatrop.

Analogues of the drug Omnitrop on the pharmacological group (hormones of the hypothalamus, pituitary, gonadotropins and their antagonists):

• Adiurecrin;
• Adiuretin;
• Alterpur;
• The biosome;
• Bravelle;
• Vasomyrin;
• Genotropin;
• Genfastat;
• Gonadotropin;
• Danoval;
• Dianodiol;
• Gentropine;
• Dinatrop;
• Diferelin;
• Zoladex;
• Luveris;
• Menogon;
• Menopur;
• The Merial;
• Modastatin;
• Nativa;
• Norditropin;
• Norprolac;
• Ovitrel;
• Oxytocin;
• Organutran;
• Pabal;
• Peptorelin;
• Pergoveris;
• Pergonal;
• Pureghon;
• Rastan;
• Remestip;
• Sizen;
• Sandostatin;
• Sigetin;
• Signyfor;
• Sinakten depot;
• Somatropin;
• Somatulin;
• Stylamine;
• Tirodzhin;
• Tyroliberin;
• Tractocyl;
• Triptorelin;
• Horagon;
• Choral;
• Humatrop;
• Humegon;
• HuMoG;
• Cetrotid;
• Elonva;
• Emosint.

Review of the endocrinologist

In my many years of practice Omnithrop was prescribed twice. The first patient is a boy born with a low growth for gestational age and with a pronounced muscular hypotension. Subsequently, he was diagnosed with Prader-Willi syndrome. The second patient is a girl with the Shereshevsky-Turner syndrome. Both patients for a long time received treatment with Omnitrop, against which a positive trend was traced: an increase in the annual growth of 3 or more centimeters. There were no recorded adverse reactions to therapy with this hormonal drug.

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