Genotropin

Genotropin is a drug of somatotropin - a substance synthesized with the help of specific recombinant technologies, similar to the growth hormone contained in the human body.

[1], [2], [3], [4]

Indications Genotropin

It is used in children in such cases:

• problems with growth, arising from the inadequate isolation of the STG element by the body;
• disorders of growth processes when the child is sick with Turner's syndrome ;
• problems with growth in a child who has chronic kidney failure;
• occurring in the intra-uterine period, growth retardation;
• people with Prader-Willi syndrome.

Adults prescribe medication for diagnosed somatotropin deficiency.

[5]

Release form

The drug release is realized as a lyophilizate with a solvent for injection liquid.

The first pre-filled handle with a volume of 5.3 mg contains 1 cartridge for 2 chambers (in the anterior one there is a lyophilizate, and in the back there is a solvent). Inside the box there is 1 such pen.

Also, such a handle can have a volume of 12 mg. Handles with such capacity are packed in packs on the first or 5 pieces.

Pharmacodynamics

Children with insufficiency of internal somatropin, as well as those who suffer from Prader-Willi syndrome, the drug potentiates linear skeletal growth and increases its speed.

Both in an adult and a child, a medicine maintains a healthy body structure, contributing to muscle growth and fat mobilization. The most sensitive to STH is the fatty tissue that has a visceral type.

In addition to stimulating the processes of lipolysis, the substance reduces the volume of passage of triglycerides to fat stores. The STH component raises the IRF-1 substances and, in addition, IRFSB-3 inside the blood serum.

Along with this, the medicine has an effect on the processes of carbohydrate, and besides fat and water-electrolyte metabolism. The STG helps stimulate the hepatic endings to LDL, and also affects the lipoprotein and lipid profiles inside the serum.

In general, the use of medicament in people with somatropin deficiency can reduce the LDL, as well as apolipoprotein B inside the blood serum. Along with this, there may be a decrease in the values of total cholesterol.

Somatotropin raises the values of insulin, but fasting sugars at the same time often remain the same. A child with hypopituitarism on an empty stomach can have hypoglycemia, which disappears when using drugs.

The medication restores the volumes of tissue fluids with plasma that decrease in case of STH deficiency, and besides it helps to keep potassium with sodium and phosphorus.

The drug stimulates the activity of bone metabolism. In people with a deficiency of somatotropin, as well as osteoporosis with prolonged therapy with the use of STH, there is a restoration of bone density with a mineral structure.

The use of medication potentiates physical endurance and muscular strength.

Along with this, the STG increases the volume of cardiac output, but the structure of such an impact has not yet been determined. A certain role in this process can be played out by the worsening of the resistance of peripheral vessels.

In persons with a deficiency of the STH component, weakening of mental characteristics may be recorded, and, in addition, a change in the mental state. The substance increases vitality, helps improve memory, and in addition affects the level of cerebral neuronal mediators.

[6], [7]

Pharmacokinetics

Suction.

The bioavailability of STH, introduced by the SC method, is approximately 80% (in both volunteers and patients with a deficiency of somatotropin). After subcutaneous administration of a 0.035 mg / kg dose, Cmax values within the blood plasma range from 13-35 ng / ml. It takes 3-6 hours to reach this level.

Excretion.

The half-life of the substance after intravenous injection in people with STH deficiency is about 0.4 hours. But with subcutaneous application this interval can be increased up to 2-3 hours. The observed difference may be associated with a delayed absorption from the site of the injection during injections.

[8], [9], [10], [11]

Dosing and administration

The dosages of the drug substance and the mode of use are determined separately for each child. Injection is administered subcutaneously, and for each new procedure, the injection site should be changed to avoid lipoatrophy.

Growth disorder due to lack of allocated STH in a child.

Often, a dosage of 0.025-0.035 mg / kg or 0.7-1.0 mg / m ² per day is expected . Also, there are data on the use of drugs in higher portions.

If GDR symptoms persist and in adolescence, therapy should continue until a full somatic development (bone mass indexes, as well as body structure) is achieved. It is necessary to monitor the process of achieving the required peak of bone mass values, defined as the T> -1 mark (standardization with respect to the average peak of bone mass in an adult, measured using a 2-energy X-ray absorptiometry that takes into account the ethnic and gender identity of a person ). This is one of the main medical goals in the transition period.

Schemes of therapy in adults.

The size of the initial dosage in an adult with a STH deficiency is 0.15-0.3 mg (about 0.45-0.9 IU) per day. In this case, the maintenance dose is selected separately, taking into account the sex and age of the patient; it only rarely exceeds the 1.3 mg mark (4 ME) per day.

It should be borne in mind that a woman may need a higher dose than a man. Since the healthy physiological production of somatotropin decreases with age, the portion of drugs can be reduced in proportion to the age.

Clinical as well as negative symptoms and the selection of IGF-1 indices within the blood serum can be used as a guide during the selection of serving sizes.

The drug at a dose of 5.3 mg (is 16 IU), as well as 12 mg (is 36 IU) is administered subcutaneously with the use of injector pens - respectively, Nos. 5.3 and 12. After inserting the cartridge inside the injector, the process of diluting the medicine is carried out automatically. At this time, the solution should not be shaken.

[16], [17], [18], [19], [20], [21]

Use Genotropin during pregnancy

The number of clinical data regarding the use of Genotropin in pregnant women is limited. Because of this, in this period it is necessary to carefully evaluate the need for drug use and existing risks.

When pregnancy progresses normally, the pituitary somatotropin values decrease significantly after the 20th week, undergoing almost complete replacement by placental substance by the 30th week. Because of this, the need for substitution treatment with Genotropin in the 3rd trimester is considered low.

Contraindications

The main contraindications:

• presence of signs of tumor growth, including uncontrolled growth of intracranial neoplasms that are benign (antitumor treatment should be completed before Genotropin is used);
• critical pathological conditions in the acute form that arise in patients due to surgical procedures inside the peritoneum or on the open heart, and in addition, provoked by multiple trauma and acute respiratory insufficiency;
• obesity in severe degree (with weight / increase proportions of more than 200%) or severe forms of respiratory disorders in people suffering from Prader-Willi syndrome;
• closing of epiphyseal growth sites in the region of tubular bones;
• the presence of intolerance relative to any element of the drug.

Caution is necessary when used in individuals with elevated ICP values, diabetes mellitus, or hypothyroidism.

[12]

Side effects Genotropin

In adults, development of negative symptoms associated with fluid retention may be noted: among these are myalgia, peripheral edema, foot pastost, paresthesia and arthralgia. These signs often have a weak or moderate intensity, develop during the first months of therapy and pass independently or after a decrease in dosage of drugs. The frequency of occurrence of these disorders is determined by the dosage of the medication and the age of the patient, and besides it may be inversely proportional to the age when a person has developed a deficiency of STH. In children, such disorders occur quite rarely.

Among other adverse events:

• disorders affecting the operation of the central nervous system: occasionally there is an increase in the level of ICP, which is benign. Puffiness in the optic nerve can also occur;
• problems with the endocrine function: occasionally can develop a type 2 diabetes mellitus. In addition, there is a decrease in serum cortisol values. The therapeutic significance of this phenomenon is considered to be limited;
• lesions in the musculoskeletal structure: dislocations or subluxations of the femoral head, where there is pain in the knee area with the hip and limping. People with Prader-Willi syndrome may have scoliosis (because the drug increases the growth rate). Myositis is noted singly (perhaps it develops under the influence of the preservative of m-cresol, which is an integral part of the drug);
• allergy symptoms: itching and eruptions on the epidermis;
• local manifestations: at the site of the introduction there are pains, rashes, a feeling of numbness, and besides itching, swelling and hyperemia with lipoatrophy;
• other disorders: the appearance of leukemia occurs sporadically in children, but the frequency of leukemia development is similar to that recorded in children without a lack of STH.

[13], [14], [15]

Overdose

Manifestations of acute intoxication - the development of first hypoglycemia, and later - hyperglycemia. With prolonged overdose, the occurrence of known effects of an overabundance of human STG (such as gigantism or acromegaly) may occur.

To eliminate such manifestations, it is necessary to cancel the medicine and perform symptomatic procedures.

[22]

Interactions with other drugs

Combination of the drug with GCS leads to a weakening of its stimulating effect with respect to growth processes.

Combination of genotropin with thyroxine can lead to the appearance of a moderate form of thyrotoxicosis.

The drug with simultaneous use is able to increase the clearance rates of compounds metabolized by isoenzyme CYP3A4 (among these are GCS, sex hormones, cyclosporine and anticonvulsants). The clinical significance of this influence has not yet been studied.

Storage conditions

Genotropin should be kept in a dark place and closed from children's access. Temperature values are within the limits of 2-8 ° C. Do not freeze both the prepared solution and the cartridge.

Shelf life

Genotropin is allowed to be used within 3 years of the release of the drug. Shelf life of the finished product (if kept in a refrigerator with a temperature in the range of 2-8 ° C) is 1 month.

[23]

Analogues

The analogues of the medication are preparations of Biorostan, Zomakton, Somatin and Biosome with Nutropin, and in addition Grotropin, Rastan, Gentropine with Norditropin and Humatrop.

[24], [25]