Humatrope

Humatrope is a drug containing hormones of the anterior pituitary lobe.

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Indications Humatrope

It is used in pediatrics in the following cases:

• long-term therapy in children with growth disorders due to insufficient secretion of normal natural STH;
• long-term treatment in case of short stature (in case of Ullrich syndrome in a child);
• therapy for severe growth retardation - in prepubertal children suffering from chronic renal failure;
• long-term therapy for short stature - children who were born too small for their gestational age ( intrauterine growth retardation ) and cannot catch up with other children in height by the age of 2;
• long-term therapy for short stature that is not associated with a deficiency in the level of STH;
• long-term therapy for short stature or growth retardation – children with the homeobox gene for short stature and open epiphyses.

Adults are prescribed it as a replacement treatment for severe STH deficiency.

Release form

The substance is released in the form of powder, inside glass cartridges with a volume of 6 or 12 mg. A syringe with a special solvent is provided with them.

Pharmacodynamics

The substance STH promotes the stimulation of linear growth in children who lack normal natural somatotropin, as well as in children whose short stature is associated with Ulrich's syndrome. Due to the moderate increase in body length due to the use of STH and human somatropin (of pituitary origin), an effect on the growth plates of long bones develops.

Treatment of a child with growth hormone deficiency results in an increase in the concentration and growth rate of the IGF-1 element, similar to that seen with human pituitary growth factor. It also stimulates intracellular protein binding and nitrogen retention.

The substance STH is therapeutically equivalent to the human growth hormone of pituitary origin and also achieves pharmacokinetic parameters that are observed in healthy adults.

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Pharmacokinetics

In adult male volunteers, a 100 mcg/kg dose results in plasma Cmax values of approximately 55 ng/mL, with a half-life of approximately 4 hours and an AUC [0-∞] of approximately 475 ng*hr/mL.

Dosing and administration

The dosage regimen and application scheme for Humatrop are selected for each patient individually.

Children with GH deficiency require 0.025-0.035 mg/kg per day (subcutaneous injections). In addition, intramuscular administration can also be used.

Adults with STH deficiency initially require 0.15-0.30 mg/kg per day (via subcutaneous injection). This dose is gradually increased, taking into account the patient's condition, to a maximum of 0.08 mg/kg (equivalent to 0.25 IU/kg) over 7 days. Dosage titration is based on the negative symptoms that the patient experiences, as well as on determination of plasma IGF-1 values. With age, the required dosage may decrease.

Elderly people may be more sensitive to the effects of Humatrope, making them more likely to experience negative symptoms. Therefore, they should be prescribed a lower initial dose of the drug and then increased more slowly.

People with Ulrich syndrome are administered 0.045-0.050 mg/kg of the drug per day - through subcutaneous injections (it is recommended to carry out the procedure in the evenings). The dosage regimen and selection of the scheme are carried out individually for each individual.

Prepubertal children with chronic renal failure should be prescribed 0.045-0.050 mg/kg (equivalent to approximately 0.14 IU/kg) of the drug per day in the form of subcutaneous injections.

Children born too small for their gestational age require subcutaneous administration of 0.035 mg/kg of the drug per day.

Short individuals without GH deficiency require a weekly dose of up to 0.37 mg/kg of the drug via subcutaneous injection. The dosage should be divided into equal portions for use 3-7 times per week.

People with SHOX deficiency should be administered 0.045-0.050 mg/kg of the drug per day via subcutaneous injection.

Overweight people need to select portions taking into account their weight, because they have a stronger tendency to develop negative symptoms.

Women with elevated estrogen levels may require higher doses of the drug than men. When taking estrogen orally, women may need to increase the dose.

Injection sites should be changed regularly to avoid the development of lipoatrophy.

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Use Humatrope during pregnancy

No reproductive tests have been performed using STH on animals. There is no information regarding the possible negative impact of STH on reproductive activity or the fetus when used in pregnant women. However, somatotropin can be prescribed during pregnancy only if absolutely necessary.

No tests have been performed using STH in lactating women. There is no data on whether the drug is excreted in breast milk. Therefore, the medication should be prescribed with great caution during this period.

Contraindications

STH is prohibited in the presence of any symptoms of active malignant processes; antitumor treatment must be completed before starting therapy with STH. If signs of tumor growth are observed, treatment with Humatrop must be stopped.

Among other contraindications:

• should not be prescribed in case of intolerance to any of the components of the medication;
• if the patient has hypersensitivity to glycerin or metacresol, it is prohibited to dissolve STH in the supplied solvent;
• the use of drugs to stimulate growth processes in children with already closed epiphyses;
• in severe and acute conditions of the patient caused by complications due to a surgical procedure in the open heart area or an operation in the abdominal area, and in addition due to a large number of injuries or acute respiratory failure.

Side effects Humatrope

Most often, the use of the drug leads to the development of hypothyroidism, and in adults - headaches, swelling or arthralgia. Often there are also manifestations at the injection site, hypersensitivity to the solvent, insomnia, increased blood pressure, paresthesia, hyperglycemia, hypothyroidism, carpal tunnel syndrome and myalgia (adults), as well as swelling (children). Rarely, hyperglycemia (children), gynecomastia and a feeling of general weakness (adults) are noted. Paresthesia, myalgia, increased intracranial pressure (benign) and gynecomastia are noted alone.

Sudden death has been reported in children with Prader-Willi syndrome and 1+ of the following risk factors: upper respiratory tract obstruction or history of sleep apnea, severe obesity, and known respiratory tract infection. Slipped capital femoral epiphysis (often seen in people with endocrine disorders) has also been reported. Anti-GH antibodies have been found in some children with GH deficiency in clinical trials. Leukemia has occasionally developed in children treated with the drug, but there is no evidence of increased incidence of leukemia in individuals without risk factors.

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Overdose

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

Interactions with other drugs

Diabetics using concomitant GH therapy may require adjustment of insulin or other antidiabetic drug dosages.

Excessive use of GCS may interfere with the development of an optimal response to GH. If a patient requires replacement therapy with GCS, dosages and compliance should be carefully monitored to prevent the development of adrenal insufficiency or suppression of growth stimulation effects.

STH is an inducer of the activity of hemoprotein P450 (CYP), due to which a decrease in plasma parameters and, accordingly, a weakening of the therapeutic effectiveness of drugs whose metabolism occurs with the help of hemoprotein CYP3A (among these are corticoids, sex hormones, anticonvulsants and cycloserine) can be observed.

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Storage conditions

Humatrop must be kept out of the reach of children; the medicine must be stored in a refrigerator at a temperature of 2-8°C.

Shelf life

Humatrop can be used within 36 months from the date of production of the therapeutic agent. The finished solution of the drug has a shelf life of 4 weeks.

Analogues

The analogs of the drug are the drugs Biosoma, Somatropin, Norditropin with Genotropin, as well as Rastan, Jintropin, Norditropin penset 12 with Saizen, Crescormon and Norditropin NordiLet with Norditropin Simplex, as well as human somatotropin.