Genotropin
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Prices in online pharmacies:
from 4950 rub.
Buy
Genotropin is a somatotropic drug that stimulates growth and increases body weight.
Release form and composition
The dosage form of Genotropin is a lyophilisate for preparing a solution for subcutaneous (s / c) administration: white; solvent - transparent colorless (in two-section cartridges for the Genotropin Pen 5,3 and 12 reusable injector, in a cardboard box 1 or 5 cartridges).
Composition of 1 cartridge (5,3 / 12):
- the active substance of the lyophilisate (in the first section): recombinant somatropin - 6.1 or 13.8 mg (18.4 or 41.4 ME);
- auxiliary components of the lyophilisate (in the first section): glycine - 2.3 / 2.3 mg; mannitol - 1.8 / 14 mg; anhydrous sodium hydrogen phosphate (in the form of dodecahydrate) - 0.32 / 0.46 mg; anhydrous sodium dihydrogen phosphate (in the form of monohydrate) - 0.33 / 0.47 mg;
- solvent (in the second section): mannitol - 45/32 mg; m-cresol - 3.4 / 3.4 mg; water for injection - up to 1.14 / 1.13 ml.
The composition of 1 ml of the solution obtained after mixing the contents of both sections of the cartridge:
- active substance: recombinant somatropin - 5.3 or 12 mg (16 or 36 ME);
- auxiliary components (5,3 / 12): m-cresol - 3/3 mg; glycine - 2/2 mg; mannitol - 41/40 mg; anhydrous sodium hydrogen phosphate (in the form of dodecahydrate) - 0.28 / 0.4 mg; anhydrous sodium dihydrogen phosphate (in the form of monohydrate) - 0.29 / 0.41 mg; water for injection - up to 1/1 ml.
Indications for use
Children
Genotropin is prescribed for growth retardation associated with the following reasons:
- insufficient secretion of growth hormone;
- Shereshevsky - Turner and Prader - Willie syndrome;
- chronic renal failure;
- intrauterine developmental disorders (in children who have not reached the standard growth rate by the age of 2 years).
Adults
Genotropin, as a substitution therapy, is prescribed for confirmed severe acquired / congenital growth hormone deficiency in patients who meet one of the following 2 criteria:
- the manifestation of the disease in childhood: in cases when growth hormone deficiency associated with congenital, genetic, idiopathic or acquired causes was observed in childhood;
- manifestation of the disease in adults: in cases where there is only a deficiency of growth hormone or in combination with a deficiency of other hormones (hypopituitarism), which is associated with a disease of the hypothalamus or pituitary gland, as well as with trauma, radiation therapy or surgery.
Contraindications
Absolute:
- symptoms of tumor growth, including uncontrolled growth of a benign intracranial tumor (antitumor therapy must be completed before starting Genotropin use);
- malignant neoplasms in the active course of any localization;
- critical conditions, acutely developed in patients due to surgery on the abdominal cavity or open heart, acute respiratory failure and multiple injuries;
- critical conditions that arose during the use of Genotropin (an assessment of the ratio of benefits to risks is required);
- severe obesity (weight / height ratio more than 200%) or severe respiratory disorders in patients with Prader-Willi syndrome;
- growth stimulation in pediatric patients after the closure of the growth zones of the epiphyses of the tubular bones;
- pregnancy;
- individual intolerance to the components of the drug.
Relative (diseases / conditions in which the use of Genotropin requires caution):
- intracranial hypertension;
- diabetes;
- Prader-Willi syndrome;
- hypothyroidism;
- combined use with glucocorticosteroids;
- lactation period.
Method of administration and dosage
Genotropin is administered subcutaneously; to prevent lipoatrophy, the injection site must be changed.
The dose is determined individually.
Depending on the indications for children is usually administered following daily doses (mg per kg of body weight / mg per m 2 body surface area / IU per kg of body weight / IU per m 2 body surface area):
- intrauterine growth retardation: 0.033–0.067 / 1–2 / 0.1–0.2 / 3–6;
- insufficient secretion of growth hormone: 0.025–0.035 / 0.7–1 / 0.07–0.1 / 2.1–3;
- Shereshevsky-Turner syndrome: 0.045–0.05 / 1.4 / 0.14 / 4.3;
- Prader-Willi syndrome: 0.035 / 1 / 0.1 / 3;
- chronic renal failure: 0.045-0.05 / 1.4 / 0.14 / 4.3.
The adult initial daily dose for growth hormone deficiency is from 0.15 to 0.3 mg (0.45-0.9 IU). The maintenance dose is determined individually depending on age and gender. In rare cases, it is higher than 1.3 mg (4 IU) per day. Women may need higher doses than men. Since normal physiological production of growth hormone decreases with age, the dose may be reduced according to age.
When choosing a dose, you can be guided by clinical and side effects, as well as an indicator of serum IGF-1 in the blood.
Genotropin 5.3 mg and 12 mg are administered using appropriate injectors. After the cartridge is placed in the injector, dilution occurs automatically. At the same time, you cannot shake the solution.
Side effects
The incidence of adverse reactions is determined according to the following scale:> 10% - very often; > 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01%, taking into account isolated cases - very rare.
- central nervous system: rarely - benign intracranial hypertension, optic nerve edema may occur;
- musculoskeletal system: subluxation / dislocation of the femoral head, accompanied by a limp, pain in the knee and hip; with Prader-Willi syndrome, scoliosis may develop (associated with increased growth rate); very rarely - myositis;
- endocrine system: rarely - type 2 diabetes mellitus, a decrease in serum cortisol levels (the clinical significance of this disorder seems to be limited);
- disorders associated with fluid retention: often - pasty lower extremities, peripheral edema, arthralgia, paresthesia, myalgia (these side effects are typical for adult patients; in most cases they are mild or moderate, as a rule, they appear during the first months therapy and decrease spontaneously or after a dose reduction; the frequency of violations depends on factors such as the dose used and age; it is possibly inversely proportional to the age at which growth hormone deficiency developed; in pediatric patients, these disorders are observed in rare cases);
- allergic reactions: itching and skin rash;
- local reactions (at the injection site): often - rash, soreness, itching, lipoatrophy, numbness, swelling, hyperemia;
- others: in isolated cases - the development of leukemia in children (the incidence of leukemia is comparable to that in children without growth hormone deficiency).
special instructions
If a critical condition occurs (for any reason) during substitution therapy, it is necessary to correlate the benefits and risks of continuing to use Genotropin.
Deaths have been reported in children with Prader-Willi syndrome with one or more risk factors (respiratory disorders, severe obesity, unidentified respiratory infections, sleep apnea) while using growth hormone.
Another possible risk factor is the patient's male gender. Patients with Prader-Willi syndrome must first be examined for upper airway obstruction. If signs of upper airway obstruction appear during treatment (including increased / appearance of snoring, obstructive apnea or similar clinical symptoms), the drug is discontinued. Patients with Prader-Willi syndrome should be evaluated for sleep apnea and should be closely monitored if suspected. In patients from this group, it is necessary to control the weight and symptoms of respiratory infections; in cases of their appearance, it is necessary to begin the most active therapy as soon as possible.
The use of the drug promotes the activation of the transition of the hormone T4 to T3, which leads to an increase in the concentration of T3 and a decrease in the concentration of T4 in the blood serum. In most cases, the level of these hormones in the peripheral blood remains within the normal range. However, in patients with latent subclinical central hypothyroidism, this can cause hypothyroidism. In this regard, it is recommended to conduct studies of thyroid function after starting therapy and after adjusting the dose of the drug.
In case of secondary growth hormone deficiency, which is due to the treatment of a malignant neoplasm, it is recommended to monitor more closely for the appearance of symptoms of tumor recurrence.
In chronic renal failure, Genotropin is prescribed only to those patients whose renal function is reduced by more than 50%. In order to confirm growth disorders, this indicator must be monitored throughout the year. During therapy, it is necessary to continue conservative treatment of renal failure. In case of kidney transplantation, the drug is canceled.
Genotropin can decrease the sensitivity of peripheral receptors to insulin. Therefore, patients should be examined for a decrease in glucose tolerance before prescribing the drug. The risk of developing type 2 diabetes is greatest in patients with other risk factors, including overweight, a family history of diabetes mellitus, glucocorticosteroid therapy, or a previously known impaired glucose tolerance. In patients with diabetes mellitus during the period of Genotropin therapy, a dose adjustment of hypoglycemic drugs may be required.
With the development of myalgia or increased pain at the injection site, it is necessary to assume the occurrence of myositis. When confirming the diagnosis, a form of somatropin without m-cresol should be used.
In patients with endocrine disorders, subluxation / dislocation of the femoral head may develop more frequently. Children who have lameness should be carefully examined if Genotropin is prescribed.
If visual impairment, recurrent / severe headaches, vomiting and / or nausea appear, fundus examination is recommended to detect papilledema. In cases of confirmation of the diagnosis, it is necessary to assume the presence of benign intracranial hypertension. Treatment with Genotropin is temporarily stopped if necessary. When resuming the use of the drug, it is necessary to carefully monitor the patient's condition.
Due to the likelihood of the formation of antibodies to the drug, in the absence of a therapeutic response, it is necessary to conduct studies of the titer of antibodies to somatropin.
Genotropin is not effective if growth factors are not synthesized in the body, or in the absence of growth factor receptors.
Before dilution, Genotropin can be stored in a patient for 1 month at temperatures up to 25 ° C.
Drug interactions
With the combined use of Genotropin with certain drugs / substances, the following effects may develop:
- thyroxine: moderate hyperthyroidism develops;
- glucocorticosteroids: the stimulating effect of Genotropin on the growth process decreases;
- compounds metabolized by the CYP3A4 isoenzyme, including anticonvulsants, sex hormones, corticosteroids, cyclosporine: their clearance increases (the clinical significance of this effect has not been studied).
Analogs
Genotropin analogues are: Jintropin, Dinatrop, Humatrop, Norditropin NordiLet, Rastan, Omnitrop.
Terms and conditions of storage
Store in a place protected from light at a temperature of 2-8 ° C. Keep out of the reach of children.
The shelf life is 3 years.
The prepared solution can be stored in the refrigerator for 4 weeks. Do not freeze the drug in the cartridge and the finished solution.
Terms of dispensing from pharmacies
Dispensed by prescription.
Genotropin: prices in online pharmacies
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Drug name Price Pharmacy |
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Genotropin 5.3 mg 16 IU lyophilisate for preparation of a solution for subcutaneous administration complete with a solvent 1 pc. 4950 RUB Buy |
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
