Humatrop

Humatrop is a medication containing hormones of the anterior pituitary lobe.

[1]

Indications Humatropa

It is used in pediatrics in such cases:

• prolonged therapy in children with growth disorders due to insufficient release of normal natural GH;
• long-term treatment in case of short stature (with Ulrich syndrome in a child);
• therapy for severe growth retardation - to children in prepubertal age with chronic renal failure;
• long-term therapy for short stature - for children who were born too small for their gestational age ( intrauterine growth retardation ) and cannot catch up with other children under 2 years old;
• long-term therapy for short stature, which is not associated with a deficiency of GH level;
• long-term therapy for short stature or growth retardation - children with a short-stature homeobox gene and open epiphyses.

Adults are prescribed as a substitution treatment for severe deficiency of GH.

Release form

The release of the substance is realized in the form of a powder, inside 6 or 12 mg glass cartridges. Included with them is a syringe with a special solvent.

Pharmacodynamics

Substance STH stimulates linear growth in children who lack normal natural growth hormone, and in addition in children whose short stature is associated with Ulrich syndrome. Due to a moderate increase in body length due to the use of growth hormone and human somatropin (pituitary nature), the effect on the growth plates of long bones is developed.

Treatment in a child with a STG deficiency leads to an increase in the concentration and growth rate of the element IGF-1, which is similar to that when using human growth factor of a pituitary nature. At the same time, it also stimulates intra-cell protein binding and nitrogen retention.

The substance GH is therapeutically equivalent to the human growth hormone that has the pituitary nature, and also achieves pharmacokinetic indices that are observed in healthy adults.

[2], [3], [4], [5], [6],

Pharmacokinetics

In adult male volunteers, a serving of 100 μg / kg results in plasma Cmax values of approximately 55 ng / ml; however, the half-life is approximately 4 hours, and the AUC [0-∞] level is approximately 475 ng * h / ml.

Dosing and administration

The dosage regimen and the scheme of using Humatrop are selected for each patient separately.

Children with deficiency of GH are required to administer daily (p / c injection) at 0.025-0.035 mg / kg. In addition, it can be used in the / m introduction.

Adults with a deficiency of STH first need to be administered at 0.15-0.30 mg / kg per day (via sc injection). This portion is gradually increased, taking into account the condition of the patient, up to a maximum of 0.08 mg / kg (corresponding to 0.25 IU / kg) in 7 days. Titration of dosage is based on the negative symptoms that appear in the patient, and besides on the determination of plasma values of IGF-1. With age, the required dosage may be reduced.

Older people may have a higher sensitivity in terms of the effect Humatrop has, which increases their tendency to the appearance of negative symptoms. Therefore, they need to prescribe a lower initial dose of the drug, and its subsequent increase is performed more slowly.

People with Ulrich syndrome are injected at 0.045-0.050 mg / kg of the drug per day - through sc injection (it is recommended to carry out the procedure in the evenings). The dosing regimen and the selection of the scheme are performed individually for each individual.

Children who are in prepubertal age and are suffering from chronic renal function failure should be prescribed with 0.045-0.050 mg / kg (corresponding to approximately 0.14 IU / kg) medications per day in the form of s / c injections.

Children born too small for their gestational age are required to inject sc with a method of 0.035 mg / kg of the drug per day.

Low-growing people without GH deficiency require the introduction of a weekly portion of up to 0.37 mg / kg of the drug via sc injection. The dosage should be divided into equal portions for use 3-7 times per week.

Persons with SHOX-deficiency need to be administered daily at 0.045-0.050 mg / kg of the drug via sc injection.

Overweight people need to pick up a portion, given the indicators of mass, because they have a stronger tendency to the appearance of negative symptoms.

Women who have increased estrogen levels may require higher dosages of drugs than men. When taking estrogen inside may need to increase the portion of women.

The injection sites should be changed regularly - to avoid the appearance of lipoatrophy.

[8]

Use Humatropa during pregnancy

Reproductive activity tests with the use of GH were not performed on animals. There is no information about the possible negative effects of growth hormone on reproductive activity or the fetus when it is used in pregnant women. But to appoint somatotropin during pregnancy is possible only if there is an urgent need.

Tests with the use of growth hormone in lactating women were not conducted. There is no evidence as to whether the drug is excreted in breast milk. Therefore, the drug in this period should be prescribed very carefully.

Contraindications

Growth hormone should not be used if there are any symptoms of active malignant processes; It is necessary to finish the antitumor treatment before initiating therapy with GH. If there are manifestations of growth of tumors, it is necessary to stop treatment with the use of Humatrop.

Among other contraindications:

• can not be prescribed for intolerance against the elements of the drug;
• if the patient is hypersensitive to glycerol or metacresol, it is forbidden to dissolve growth hormone in the attached solvent;
• the use of drugs to stimulate growth processes in children with already closed epiphyses;
• in severe and acute condition of the patient, caused by complications due to a surgical procedure in the open heart area or surgery in the abdominal area, and in addition due to the large number of injuries or respiratory insufficiency in acute form.

Side effects Humatropa

Most often, the use of the drug leads to the development of hypothyroidism, and in adults - headaches, puffiness or arthralgia. Often there are also manifestations at the injection site, hypersensitivity to the solvent substance, insomnia, increased blood pressure, paresthesia, hyperglycemia, hypothyroidism, carpal tunnel syndrome and myalgia (adults), and also puffiness (children). Hyperglycemia (children), gynecomastia and a feeling of general weakness (adults) are rarely observed. Paresthesias, myalgias, an increase in the level of ICP (benign) and gynecomastia are singled out individually.

There are reports of sudden deaths in children with Prader-Willi syndrome and having 1+ factors listed below: obstruction, affecting the upper respiratory system or sleep apnea (in history), with severe severity of obesity and diagnosed infection inside the respiratory ducts. There is also evidence of epiphyseolysis in the region of the femoral head bone (often observed in people with impaired endocrine function). During clinical tests, the formation of antibodies against GH was found in some children with GH deficiency. Individuals in children who used the drug developed leukemia, but there was no evidence of an increase in the frequency of occurrence of leukemia in people without risk factors.

[7]

Overdose

In acute intoxication, hypoglycemia may first develop, and later hyperglycemia. Prolonged overdose can provoke signs of acromegaly or gigantism - in accordance with the known manifestations of excess GH.

Interactions with other drugs

Diabetics who use concomitant STH therapy may need to revise their insulin dosage or other antidiabetic drugs.

Excessive use of GCS can become an obstacle to the development of an optimal response to GH. If a patient requires substitution treatment with GCS, it is necessary to carefully monitor dosage sizes and compliance to prevent the occurrence of adrenal insufficiency or suppression of the effects of growth stimulation.

Growth hormone is an inducer of hemoprotein P450 (CYP) activity, which can lead to a decrease in plasma parameters and, accordingly, a weakening of the therapeutic efficacy of drugs whose metabolism proceeds with the help of CYP3A hemoprotein (such as corticoids, sex hormones, anticonvulsants and cycloserine).

[9], [10]

Storage conditions

Humatrop is required to be kept in a closed area from the penetration of children; The medicine should be stored in a refrigerator at temperatures between 2-8 ° C.

Shelf life

Humatrop can be used within 36 months of the manufacture of a therapeutic agent. Ready solution of drugs has a shelf life of 4 weeks.

Analogs

Analogues of the drug are Biosome, Somatropin, Norditropin with Genotropin, and also Rastan, Dzhintropin, Norditropin Penset 12 with Saisen, Crescormon and Norditropin NordiLelet with Norditropin Simplex, as well as human somatotropin.