Omnitrope

Omnitrope is a growth hormone.

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Indications Omnitrope

It is used for children – in case of growth retardation due to the following conditions and pathologies:

• weak secretion of somatotropin;
• Ullrich syndrome;
• SPV;
• CRF with reduced renal function (more than 50% reduction);
• children who were born with growth parameters that are too small for their gestational age.

For adults, the drug is prescribed for replacement therapy in cases of diagnosed congenital (severe) or acquired deficiency of STH.

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Release form

The substance is released in the form of a liquid for subcutaneous injections (3.3 or 6.7 mg/ml). The volume of glass cartridges of the 1st type is 1.5 ml. The corrector contains 1, 5 or 10 such cartridges. The box contains 1 corrector.

Pharmacodynamics

Somatropin has a pronounced effect on protein, fat and carbohydrate metabolism processes. In children with a deficiency of STH, the substance promotes stimulation of bone growth of the skeleton, lengthening it by influencing the epiphyseal plates inside the tubular bones. This component helps to normalize the body structure, both in children and adults - increasing muscle mass and simultaneously reducing fat mass. The greatest sensitivity to the influence of STH is visceral adipose tissue. Together with the potentiation of lipolysis, the drug reduces the volume of triglycerides entering the body's fat reserves. The influence of STH leads to an increase in the values of the IGF-I element, as well as the protein synthesizing it (IRF-SB3).

Additionally, other effects develop:

• fat metabolism. STH stimulates the activity of liver LDL endings and changes the lipoprotein and lipid blood profile. When using the substance in people with GH deficiency, a decrease in blood values of LDL, as well as apolipoprotein B, is observed. At the same time, a decrease in cholesterol levels is noted;
• carbohydrate metabolism. The drug increases the volume of insulin released, although fasting sugar levels usually remain unchanged. Children with Sheehan syndrome may develop hypoglycemia on an empty stomach. This disorder can be eliminated with the help of STH;
• water-mineral exchange processes. GH deficiency leads to a decrease in plasma volume and the amount of extracellular fluid. Thanks to the use of Omnitrope, both of these parameters quickly increase. The substance also helps to retain potassium with sodium and phosphorus;
• metabolic processes within bone tissue. The drug activates bone metabolism processes. With prolonged use of STH in children with osteoporosis, as well as GH deficiency, bone density and mineral composition are stabilized;
• Improvement of physical condition. Long-term replacement therapy with STH causes an increase in physical endurance and muscle strength. Cardiac output also increases, but in this case the mechanism of therapeutic action remains unclear. Weakening of peripheral vascular resistance may explain this effect of STH to some extent.

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Pharmacokinetics

Suction.

When injected subcutaneously, the bioavailability of STH is approximately 80%. After subcutaneous administration of 5 mg of the substance to volunteers, plasma Cmax and Tmax values were 72±28 μg/l and 4±2 hours, respectively.

Excretion.

The mean half-life of GH after intravenous administration in GH-deficient adults is approximately 0.4 hours. Following subcutaneous injection, the half-life of Omnitrope is 3 hours.

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Dosing and administration

The drug is administered at a low rate, subcutaneously, once a day (usually before bedtime). To avoid lipoatrophy, it is necessary to regularly change the injection sites.

Dosages are selected for each patient individually, taking into account the severity of GH deficiency, weight or body surface area, as well as the therapeutic efficacy of the drug.

Use in children.

If insufficient GH secretion is observed, 0.025-0.035 mg/kg or 0.7-1 mg/m2 should be administered ^per day.

Therapy should be started as early as possible and continued until the child begins to puberty (or until the bone growth zones begin to close). Therapy can also be stopped when the desired effect has been achieved.

When treating Ullrich syndrome, it is necessary to use the medication in a dose of 0.045-0.05 mg/kg or 1.4 mg/m2 ^per day.

In order to increase growth and improve body composition, patients with SPV should be administered 0.035 mg/kg or 1 mg/m2 ^per day. The daily dose of the drug should not exceed 2.7 mg. Therapy is prohibited for children who have a growth gain of less than 1 cm per year, and whose epiphyseal bone growth areas are almost closed.

In case of CRF, against the background of which growth retardation is observed, it is necessary to administer 0.045-0.05 mg/kg per day. If the growth dynamics is insufficient, it is possible that there is a need for a higher dose of the drug. It is allowed to review the optimal dosage after six months of therapy.

When growth disturbances are observed in children born with growth parameters that are too small for their gestational age, 0.035 mg/kg or 1 mg/m2 ^per day should be used until the desired growth is achieved. Therapy should be stopped if after the first year the growth has increased by less than 1 cm.

Treatment should also be discontinued if the growth gain per year is less than 2 cm, and also taking into account the condition of the epiphyseal growth areas (if necessary). It has been established that in girls the bone age is >14 years, and in boys – >16 years.

Use in adults.

Adults with severe GH deficiency should begin replacement therapy with low doses (0.15-0.3 mg per day). Then they are gradually increased, taking into account the serum IGF-I levels. This value should be within 2 deviations from the average level for this age group. In individuals with normal initial IGF-I levels, the dose of the medication should be selected so that the IGF-I level is at the ULN, not exceeding 2 acceptable deviations.

The size of the maintenance dose is determined individually, but it usually should not exceed 1 mg per day (similar to a dosage of 3 IU per day). Lower dosages are used for older people.

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Use Omnitrope during pregnancy

It is prohibited to prescribe the medicine to pregnant women. Also, nursing mothers are required to refrain from breastfeeding during the therapy period.

Contraindications

Main contraindications:

• the presence of severe sensitivity to the elements of the drug;
• neoplasms of a malignant nature;
• urgent conditions (including conditions observed after surgical procedures on the heart or peritoneum, as well as acute respiratory failure);
• to stimulate growth in people whose epiphyseal growth zones are closed.

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Side effects Omnitrope

Adults taking the medication often experience side effects associated with fluid retention. These include stiffness in the limbs, peripheral edema, myalgia with arthralgia, and paresthesia. Typically, the severity of such symptoms is moderate, they occur in the first months of therapy and disappear on their own or after a reduction in the dose of the drug. The likelihood of these symptoms depends on the patient's age and the dosage of the drug (it is very likely that they have an irreversible relationship with the age of development of GH deficiency). However, such disorders have not been recorded in children.

Among other negative signs:

• tumors of malignant or benign, as well as unspecified nature: leukemia develops occasionally. Also, situations with the appearance of leukemia with a deficiency of GH during therapy with STH were observed in children, but it was found that this frequency is similar to cases with children with normal GH levels;
• immune damage: antibodies to STH are often formed. Approximately 1% of patients begin to develop antibodies to somatotropin after its administration. The synthesizing capacity of such antibodies is quite low, so clinical symptoms of such antibody production are not observed;
• disorders affecting endocrine function: type 2 diabetes mellitus occasionally develops;
• disorders in the functioning of the nervous system: paresthesia is often observed (adults). Paresthesia is observed less frequently in children. Sometimes adults develop carpal tunnel syndrome. Rarely, the level of intracranial pressure increases (benign form of the disorder);
• problems arising in the area of connective and skeletal-muscular tissues: often adults experience stiffness in the limbs and myalgia with arthralgia. Sometimes the same symptoms occur in children;
• systemic lesions and disorders at the injection site: peripheral edema (often in adults, less often in children). Also, children often develop transient skin manifestations at the injection site.

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Overdose

Signs of intoxication: in acute poisoning, hypoglycemia may develop first, and later hyperglycemia. Due to prolonged overdose, manifestations develop that often occur with excessive amounts of human GH (for example, gigantism or acromegaly, and in addition, hypothyroidism and decreased serum cortisol levels).

To eliminate the disorders, it is necessary to stop using the drug and carry out symptomatic procedures.

Interactions with other drugs

Data from drug interaction tests in adults with GH deficiency suggest that the use of STH increases the clearance of drugs that are metabolized by hepatic microsomal cytochrome P450 isoenzymes (especially those that are metabolized by isoenzyme 3A4). These include GCS, sex hormones, cyclosporine, and anticonvulsants. This combination may result in a decrease in their plasma levels. The clinical significance of this effect has not yet been determined.

GCS substances slow down the stimulating effect of STH on growth processes. Combined treatment with other hormones (for example, gonadotropin, estrogens, anabolic steroids, and thyroid hormones) can also affect drug effectiveness (in terms of final growth).

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Storage conditions

Omnitrope must be kept in a place out of reach of small children. It is prohibited to freeze the medicine. Temperature values are in the range of 2-8°C.

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Shelf life

Omnitrope can be used within 24 months (3.3 mg/ml form) or 18 months (6.7 mg/ml form) from the date of release of the drug.

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Application for children

It is prohibited to use Omnitrope in newborns (this includes premature babies) because it contains benzyl alcohol.

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Analogues

Analogues of the drug are such drugs as Norditropin Nordilet, Genotropin, and also Rastan with Jintropin.

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