Universal reference book for medicines
Product name: OMNITROPE ® (OMNITROPE)

Active substance: somatropin

Type: Recombinant growth hormone

Manufacturer: SANDOZ (Austria)
Composition, form of production and packaging
The solution for administration is
transparent or slightly opalescent, colorless.

1 ml 1 cartridge

Somatropin 3.3 mg 5 mg (15 IU)

Auxiliary substances: sodium hydrogen phosphate heptahydrate 1.33 mg, sodium dihydrogen phosphate dihydrate 1.57 mg, poloxamer 3 mg, benzyl alcohol (preservative) 13.5 mg, mannitol 52.51 mg, phosphoric acid qs to pH6.2 ± 0.2, sodium hydroxide - qs to pH6.2 ± 0.2, water d / u - up to 1.5 ml.

1.5 ml - cartridges (1) - plastic contoured packages (1) - cardboard packs.

The solution for administration is transparent or slightly opalescent, colorless.

1 ml 1 cartridge

somatropin 6.7 mg 10 mg (30 IU)

Auxiliary substances: sodium hydrogen phosphate heptahydrate - 1.7 mg, sodium dihydrogen phosphate dihydrate - 1.35 mg, poloxamer - 3 mg, phenol (preservative) - 4.5 mg, glycine - 27.75 mg, phosphoric acid - qs to pH6.2 ± 0.2, sodium hydroxide - qs up to pH6.2 ± 0.2, water d / u - up to 1.5 ml.

1.5 ml - cartridges (1) - plastic contoured packages (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Somatropin has a pronounced effect on the metabolism of fats, proteins and carbohydrates.
In children with a deficiency of growth hormone, somatropin 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 I (IRP-I) and its binding protein (IGF-SB3, insulin-like growth factor binding protein) increases.
Fat exchange

Somatropin 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.
Exchange of carbohydrates

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.
Water-mineral exchange

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.
Metabolism of bone tissue

Somatropin 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.
Physical activity

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.
PHARMACOKINETICS

Suction

After the SC administration, the bioavailability of somatropin is approximately 80% in both healthy individuals and in patients with growth hormone deficiency.
With the administration of Omnitrop® in a dose of 5 mg to healthy volunteers, C max of somatropin in plasma and T max was, respectively, 72 ± 28 μg / l and 4 ± 2 hours, respectively.
Excretion

The average T 1/2 somatropin after iv introduction to adult patients with a growth hormone deficiency is about 0.4 h. However, after a sc administration of T 1/2 of thedrug reaches 3 h.

Individual patient groups

Absolute bioavailability of somatropin after SC 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

In children with growth retardation:

- due to insufficient secretion of growth hormone;

- with Shereshevsky-Turner syndrome;

- with Prader-Willi syndrome (SLE);

- with chronic renal failure (CRF) with a decrease in kidney function by more than 50%;

- in children born with low growth rates for this gestational age.

In adults, as a substitution therapy with a confirmed expressed congenital or acquired growth hormone deficiency.

DOSING MODE

Somatropin is given SC, slowly, 1 time / 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 / kg / day or 0.7-1 mg / m 2 / 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 / kg / day or 1.4 mg / m 2 / day is recommended.

With Prader-Willy syndrome, the recommended dose is 0.035 mg / kg / day or 1 mg / m 2 / day for increasing body composition and improvement 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 virtually closed epiphyseal areas of bone growth.
In chronic renal failure in children accompanied by growth retardation , a dose of 0.045-0.05 mg / kg / 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 / kg / day or 1 mg / m 2 / 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 the epiphyseal growth zones, if necessary, it is confirmed that the bone age > 14 years (for girls) or> 16 years (for boys).
Table 1. Doses of the drug recommended for children.

Indications mg / kg body weight / day mg / m 2 body surface / day

Deficiency of growth hormone 0.025-0.035 0.7-1

Prader-Willi syndrome 0.035 1

Syndrome Shereshevsky-Turner 0.045-0.05 1.4

CRF 0.045-0.05 1.4

Children with low birth-weight 0.035 1

Adults

In adults with a pronounced growth hormone deficiency, it is recommended to start substitution therapy with low doses - 0.15-0.3 mg / day with subsequent gradual increase depending on serum concentration of IGF-I.
This indicator should be within 2 deviations from the average for a given age. In patients with normal initial concentration of IGF-I, the dose of the drug should be selected in such a way that the IGF-I 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 / day, which corresponds to 3 IU / day.
Elderly patients are recommended lower doses.

SIDE EFFECT

Below are summarized data on adverse reactions noted in accordance with the system-organ classification (MedDRA) and the WHO classification by frequency: very often (? 1/10);
often (? 1/100, <1/10); infrequently (? 1/1000, <1/100), rarely (? 1/10 000, <1/1000) and very rarely (<1/10 000).
A feature of patients with growth hormone deficiency is the lack of volume of extracellular fluid.
With the appointment of somatropin, this deficit is quickly eliminated. Adult patients often experience adverse reactions associated with fluid retention, such as peripheral edema, rigidity of the limbs, arthralgia, myalgia, and paresthesia. Typically, the severity of these reactions varies from moderate to moderate, they develop in the first months of treatment and are spontaneous or with a lower dose. The likelihood of these reactions depends on the dose of the drug, the age of the patient and is probably irreversibly related to age when growth hormone deficiency occurs. In children these side effects are unknown.
Benign, malignant and unspecified neoplasms: very rarely - leukemia.
In very rare cases, cases of leukemia with growth hormone deficiency in the treatment of somatotropin have been reported in children, but it was found that this frequency is similar to that of children with normal growth hormone concentrations.
From the immune system: often - the formation of antibodies to somatropin.
In the appointment of somatropin, approximately 1% of patients develop antibodies to it.The binding ability of these antibodies is small and no clinical manifestations of such antibody production have been reported.
From the endocrine system: rarely - type 2 diabetes.

From the nervous system: often - paresthesia (in adults);
infrequently - carpal tunnel syndrome (in adults), paresthesia (in children); rarely - benign intracranial hypertension.
From the musculoskeletal and connective tissue: often - stiff limbs, arthralgia, myalgia (in adults);
infrequently - stiff limbs, arthralgia, myalgia (in children).
General disorders and disorders at the injection site: often - peripheral edema (in adults);
transient skin reactions at the injection site (in children); infrequently, peripheral edema (in children).
CONTRAINDICATIONS

- malignant neoplasms;

- Urgent conditions (including conditions after operations on the heart, abdominal cavity, acute respiratory failure);

- growth stimulation in patients with closed epiphyseal growth zones;

- Pregnancy;

- the period of breastfeeding (during the period of treatment it is necessary to refuse breastfeeding);

- Newborn period (including premature infants) due to the presence of benzyl alcohol in the composition;

- Hypersensitivity to any component of the drug.

With caution: diabetes, craniocerebral hypertension, concomitant therapy with GCS, hypothyroidism (including when carrying out substitution therapy with thyroid hormones).

PREGNANCY AND LACTATION

Contraindicated in pregnancy and lactation (during treatment it is necessary to abandon breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

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, conservative treatment is prescribed (including control of acidosis, hyperparathyroidism, and nutritional status), which continues with the onset of primary therapy.
When kidney transplantation treatment should be discontinued.

At present, there is no data on the magnitude of the growth increment in the appointment of Omnitrop® to patients with CRF.

APPLICATION FOR CHILDREN

It is used in children according to indications.

Contraindicated in the period of newborns (in the number of preterm infants) due to the presence of benzyl alcohol.

APPLICATION 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, type 2 diabetes may develop with the use of somatropin, however, in the vast majority of these cases, patients had risk factors, such as obesity (including obesity with SLE), family history, SCS, or previous glucose tolerance impairment. 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 T3 concentration in the plasma.
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, incl.
deficiency of growth hormone, the displacement of the epiphyses of the femur can be noted more often than in the general population.
Detection of lameness on the background of somatropin therapy requires clinical examination and careful observation.

In the event of severe or recurrent headaches, visual impairment, nausea and / or vomiting, fundus examination is recommended to diagnose a possible edema of the optic nerve disc.
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.
Experience in people over 60 years of age is limited.

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 SLE should be screened for upper airway obstruction, sleep apnea, and respiratory infections before commencing somatropin.
If there is an obstruction of the upper respiratory tract, it must be skillfully suppressed before commencing somatropin.
Diagnosis of nocturnal sleep apnea is carried out before the application of the drug with the help of approved methods, such as polysomnography or night oximetry, and when suspicion of this syndrome occurs, careful monitoring should be carried out.
If during the treatment with somatropin signs of obstruction of the upper respiratory tract (including the appearance or strengthening of snoring) are observed, treatment should be discontinued 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 before and during the use of 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, acanthokeratodermia), 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 IGF-I before treatment and 2 times a year after its onset.
If, during repeated measurements, the concentration of IGF-I exceeds +2 standard deviations with respect to typical
values ​​for a given age and the degree of sexual development, then the ratio of concentrations of IGF-I to IRF-SB3 should be taken into account to correct 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.

Previous use in patients with Silver-Russell syndrome is also limited.
In the treatment of children and adolescents with MVGV should be borne in mind that at the termination of treatment to achieve the highest possible growth of the gain in growth may be lost.
When CRF functional renal activity before therapy should be less than 50% of normal. To confirm dysplasia need to monitor the growth dynamics within the year prior to treatment. During this period prescribed conservative treatment (including control acidosis, hyperparathyroidism, and nutritional status), which continues with the beginning primary therapy.
In renal transplantation the treatment should be discontinued.
There is currently no data on the amount of gain increase in the appointment of the drug Omnitrop® patients with CRF.
Reparative effects of somatropin in adult patients who are in critical condition as a result of complications following open heart surgery, and abdominal cavity, multiple accidental trauma, and acute respiratory failure were evaluated in two placebo-controlled studies. Mortality in patients who were prescribed 5.3 mg somatropin or 8 mg per day was higher than in the placebo group (42% and 19%, respectively). According to these results, the listed groups of patients should not be prescribed somatropin. As the safety purpose of growth hormone in patients in acute critical condition unknown, the anticipated benefits from the destination must be related to the possible risk in these patients.
It is necessary to change the place of subcutaneous injections in connection with the development of lipoatrophy.
This product contains less than 1 mmol sodium (23 mg) in 1 mL of that amount is negligible.
Since a part of Omnitropa presence of benzyl alcohol, it should not be given to premature infants or newborns, as said component toxic and can cause anaphylactic reactions in children under 3 years.
OVERDOSE

Cases of overdose are unknown.
Symptoms: Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia. During prolonged overdose may experience the signs and symptoms associated with excess human growth hormone (acromegaly development and / or gigantism, and also the development of hypothyroidism, reduced cortisol concentrations in serum).
Treatment: withdrawal of the drug, symptomatic therapy.

DRUG INTERACTION

Results of the study of drug interaction in adult patients with growth hormone deficiency suggest that administration of growth hormone increases the clearance of drugs metabolized by microsomal cytochrome P450 in the liver, especially those that are metabolized isoenzyme 3A4 - sex hormones, corticosteroids, anticonvulsants and cyclosporine, which may lead to a decrease in their concentration in the plasma. The clinical relevance of this effect has not been determined.
Corticosteroids inhibit the stimulatory effect of growth hormone on growth processes.
The effectiveness of the drug (in relation to the final height) may also be influenced by concomitant therapy with other hormones, for example gonadotrophin, anabolic steroids, estrogens and thyroid hormones.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be kept out of reach of children at a temperature of from 2 ° to 8 ° C.
Do not freeze. No need for special precautions in the destruction of unused product.
Shelf life: cartridges 5 mg / ml 1.5 - 2 years, cartridges 10 mg / 1.5 ml - 1.5 years.
Do not use the drug after the expiry date stated on the package.
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