Jintropin (lyophilisate) - instructions for use, description. Jintropin analogues and prices Analogues by composition and indications for use
Jintropin is a genetically engineered somatotropic hormone that has a powerful effect on metabolic processes, stimulates somatic and skeletal growth and, by reducing fat mass and increasing muscle mass, contributes to the normalization of body structure.
Release form and composition
Jintropin is available in the form of a lyophilizate for the preparation of a solution for subcutaneous administration. The lyophilisate is a white powder or mass, a yellowish tint is allowed. The drug is available in vials complete with a solvent (water for injection in ampoules). Sometimes the kit includes disposable syringes. One carton contains 5, 10 or 50 vials, 5, 10 or 50 solvent ampoules and 5 disposable syringes.
The active ingredient in Jintropin is somatropin. 1 bottle contains 1.33 or 3.33 mg of the active ingredient.
Auxiliary substances are the following components:
- Sodium dihydrogen phosphate;
- Mannitol;
- Sodium chloride;
- Glycine.
Indications for use
According to the instructions, Jintropin is used in adult patients as replacement therapy for confirmed acquired or congenital growth hormone deficiency.
In children, the drug is used for growth retardation due to insufficient secretion of growth hormone, for chronic renal failure in the prepubertal period, and for Shereshevsky-Turner syndrome.
Contraindications
According to the instructions, Jintropin is contraindicated during pregnancy and breastfeeding and in case of hypersensitivity to the components that make up the product.
The drug can not be used also in the following conditions:
- Malignant neoplasms;
- Acute respiratory failure;
- Conditions after surgical interventions on the heart;
- Conditions after abdominal operations;
- Active brain tumors.
Jintropin should be used with caution in intracranial hypertension, diabetes mellitus and hypothyroidism.
Method of application and dosage
Jintropin should be injected subcutaneously slowly once a day, usually at night. To prevent the development of lipoatrophy, it is recommended to change injection sites.
The contents of the vial are dissolved in 1 ml of the solvent that is included in the kit, based on the calculated dose. The solvent is taken with a syringe and injected through the stopper into the vial. Shake the vial gently until the contents are completely dissolved. The finished solution can be stored in a vial for up to 2 weeks. The storage temperature is 2-8 °C.
Dosages of Jintropin are selected individually, depending on the severity of growth hormone deficiency, body surface area and weight, as well as effectiveness in the treatment process.
With insufficient secretion of growth hormone in children, a dose of 25-35 mcg per 1 kg of the child's body weight per day is usually prescribed. Therapy should begin at an early age and continue until the closure of the bone growth zones or puberty. When the desired result is achieved, you can stop treatment.
In children with chronic renal failure, which is accompanied by growth retardation, as well as Shereshevsky-Turner syndrome, a dose of Jintropin 50 μg per 1 kg of body weight per day is prescribed. Dose adjustment may be required in case of insufficient growth dynamics.
In adults with growth hormone deficiency, an initial dose of 0.15-0.3 mg per day is prescribed. Subsequently, the dose is increased depending on the therapeutic effect.
When using Jintropin in elderly patients, lower doses are used.
Side effects
The drug can cause side effects in the form of increased intracranial pressure, which is manifested by nausea and vomiting, headaches and visual impairment.
The use of Jintropin can also cause the following side effects:
- Decreased thyroid function;
- Fluid retention with the development of peripheral edema;
- hyperglycemia;
- myalgia;
- Epiphyseolysis of the femoral head;
- Arthralgia;
- Leukemoid reactions;
- tunnel syndrome.
These side effects of Jintropin are mostly dose-dependent and transient. In such cases, dose reduction may be required.
Against the background of the use of the drug, allergic reactions may develop in the form of itching and skin rash.
The agent in some cases causes the following local reactions:
- Hyperemia;
- Swelling;
- Pain;
- Lipoatrophy at the injection site.
The active substance of Jintropin can lead to the following side effects:
- Pancreatitis, which is manifested by nausea, vomiting and abdominal pain;
- increased fatigue;
- General weakness;
- Edema of the optic disc (mainly in patients with Shereshevsky-Turner syndrome);
- Gynecomastia;
- Hearing loss and otitis media;
- Acceleration of the growth of a pre-existing nevus;
- Hip subluxation in children;
- Increase in the blood of parathyroid hormone and inorganic phosphate;
- scoliosis progression.
special instructions
In patients with diabetes mellitus, the treatment with the drug may require dose adjustment of hypoglycemic drugs. In addition, the manifestation of latent hypothyroidism is possible. Signs of hyperthyroidism may appear in patients receiving thyroxine.
Against the background of the use of Jintropin, monitoring of the condition of the fundus is required. This is especially true in cases where symptoms of intracranial hypertension appear. Cancellation of the drug is necessary for swelling of the optic nerve.
Careful observation is required if lameness is detected during treatment with the drug.
Analogues
Synonyms of Jintropin are drugs Dinatrop, Genotropin, Rastan, Humatrop, Saizen, Norditropin, Omnitrop. There are no analogues of the funds today.
Terms and conditions of storage
The shelf life of the lyophilisate is 2 years.
Instructions for use. Contraindications and release form.
INSTRUCTIONS
to use the drug
Jintropin
ATX H01AC01 Somatropin
Compound
Lyophilisate for solution for subcutaneous administration 1 vial.
active substance:
somatropin 1.33 mg (4 IU) / 3.33 mg (10 IU)
excipients: glycine; sucrose; methionine; sodium hydrogen phosphate; polysorbate 80; sodium dihydrogen phosphate monohydrate
solvent: water for injection - 1 ml
Description of the dosage form
Lyophilizate: mass or powder of white or white color with a yellowish tinge.
Solvent: Colorless, odorless, transparent liquid.
pharmachologic effect
Pharmacological action - somatotropic.
Pharmacodynamics
Jintropin® is a somatropin synthesized using recombinant technologies, identical to human growth hormone.
It has a pronounced effect on the metabolism of fats, proteins and carbohydrates. In children with endogenous growth hormone deficiency, somatropin stimulates the growth of skeletal bones in length by acting on the plates of the epiphysis of tubular bones.
In adults and children, somatropin contributes to the normalization of body structure by increasing muscle mass and reducing body fat. Visceral adipose tissue is especially sensitive to somatropin. Somatropin stimulates lipolysis and reduces the entry of triglycerides into fat depots.
Somatropin increases the concentration of insulin-like growth factor I (IGF-I) and its binding protein - insulin-like growth factor-binding protein (IRFSB-3) in the blood serum.
It also has the following effects/
lipid metabolism. It activates LDL receptors in the liver and changes the profile of lipids and lipoproteins in the blood, leading to a decrease in blood LDL, apolipoprotein B, and cholesterol concentration.
The exchange of carbohydrates. Increases insulin release, but fasting glucose concentration usually does not change. Children with hypopituitarism may develop fasting hypoglycemia. This condition is reversible with the introduction of somatropin.
Water and mineral exchange. Growth hormone deficiency is associated with decreased plasma and tissue fluid volume. Both of these indicators increase rapidly after treatment with somatropin.
Promotes the retention of sodium, potassium and phosphorus in the body.
Bone metabolism. Stimulates bone metabolism. In patients with growth hormone deficiency and osteoporosis, long-term therapy with somatropin leads to the normalization of the mineral composition and bone density.
Physical performance. Treatment with somatropin increases muscle strength and physical endurance. Cardiac output also increases, but the mechanism of this effect has not yet been elucidated. A decrease in OPSS can play a certain role in this.
Mental condition. In patients with growth hormone deficiency, there may be a decrease in mental abilities and a change in mental status. Somatropin increases vitality, improves memory and affects the balance of neurotransmitters in the brain.
Pharmacokinetics
absorption and distribution. The absorption of somatropin after s / c administration is 80%, Tmax in blood plasma is (4 ± 2) hours. The absolute bioavailability of somatropin with s / c administration is the same in males and females.
Metabolism and excretion. T1 / 2 after s / c administration reaches 3 hours. Metabolized in the kidneys and liver. About 0.1% unchanged is excreted through the intestines. There are no data on the effect on the pharmacokinetic parameters of somatropin by age, race, impaired liver, kidney or heart function.
Indications of the drug Jintropin®
In children:
- growth retardation due to insufficient secretion of growth hormone;
- growth retardation in Shereshevsky-Turner syndrome;
- growth retardation in chronic renal failure;
- growth retardation in children 4 years of age and older with a history of intrauterine growth retardation;
- growth retardation in Prader-Willi syndrome (PSW).
In adults:
- replacement therapy for confirmed severe congenital or acquired growth hormone deficiency.
Contraindications
- hypersensitivity to somatropin or any other component of the drug;
- active malignant neoplasms of any localization;
- presence of signs of brain tumor growth (anticancer therapy should be completed before the start of treatment with somatropin, treatment should be stopped if signs of tumor growth appear);
- acute emergency conditions (including those developed as a result of complications after heart or abdominal surgery, multiple injuries, acute respiratory failure);
- severe forms of obesity (weight/height ratio over 200%);
- severe respiratory disorders in patients with Prader-Willi syndrome;
- growth stimulation in patients with closed epiphyseal growth zones;
- pregnancy;
- period of breastfeeding (for the duration of treatment, breastfeeding must be stopped).
Carefully: diabetes mellitus, intracranial hypertension, hypothyroidism (including during thyroid hormone replacement therapy), concomitant therapy with corticosteroids.
Use during pregnancy and lactation
Clinical experience with the use of somatropin in pregnant women is insufficient, so the use of the drug during pregnancy is contraindicated.
Reliable information about the possibility of penetration of somatropin into breast milk is not available, therefore, for the period of treatment, breastfeeding should be stopped.
Side effects
Patients with growth hormone deficiency are characterized by a deficit in the volume of extracellular fluid. After the start of treatment with somatropin, this deficit is quickly restored. Adult patients are characterized by side effects due to fluid retention (peripheral edema, skeletal muscle rigidity, arthralgia, myalgia, paresthesia). These phenomena are usually expressed from moderate to moderate degree, appear in the first months of treatment and decrease spontaneously or after reducing the dose of the drug.
The frequency of these side effects depends on the dose of somatropin, the age of the patients, and may be inversely proportional to the age at which growth hormone deficiency occurred. In children, these side effects are observed infrequently.
The following are the undesirable reactions distributed by system organ classes and frequency of occurrence: very often (≥1 / 10); often (from ≥1/100 to<1/10); нечасто (от ≥1/1000 до <1/100); редко (от ≥1/10000 до <1/1000); очень редко (≤1/10000); частота неизвестна (невозможно оценить частоту на основании имеющихся данных).
Long-term use in children with growth hormone deficiency
General disorders and disorders at the injection site: very often - transient reactions at the injection site; frequency unknown - peripheral edema
Long-term use in children with Shereshevsky-Turner syndrome
Benign, malignant and unspecified neoplasms: infrequently - leukemia (the frequency of development does not exceed that for children with growth hormone deficiency who do not receive somatropin therapy).
From the side of metabolism and nutrition: the frequency is unknown - the development of type 2 diabetes mellitus.
From the nervous system: the frequency is unknown - paresthesia, benign intracranial hypertension.
From the musculoskeletal system and connective tissue: very often - arthralgia; frequency unknown - myalgia, skeletal muscle rigidity.
General disorders and disorders at the injection site: the frequency is unknown - transient reactions at the injection site, peripheral edema.
Influence on the results of laboratory and instrumental studies: the frequency is unknown - a decrease in the concentration of cortisol in the blood plasma (clinical significance is unknown).
Long-term use in children with CKD
Benign, malignant and unspecified neoplasms: infrequently - leukemia (the frequency of development does not exceed that for children with growth hormone deficiency who do not receive somatropin therapy).
From the side of metabolism and nutrition: the frequency is unknown - the development of type 2 diabetes mellitus.
From the nervous system: the frequency is unknown - paresthesia, benign intracranial hypertension.
From the musculoskeletal system and connective tissue: the frequency is unknown - arthralgia, myalgia, skeletal muscle rigidity.
Influence on the results of laboratory and instrumental studies: the frequency is unknown - a decrease in the concentration of cortisol in the blood plasma (clinical significance is unknown).
Long-term use in children with a history of intrauterine growth retardation
Benign, malignant and unspecified neoplasms: infrequently - leukemia (the frequency of development does not exceed that for children with growth hormone deficiency who do not receive somatropin therapy).
From the side of metabolism and nutrition: the frequency is unknown - the development of type 2 diabetes mellitus.
From the nervous system: the frequency is unknown - paresthesia, benign intracranial hypertension.
From the musculoskeletal system and connective tissue: infrequently - arthralgia; frequency unknown - myalgia, skeletal muscle rigidity.
General disorders and disorders at the injection site: often - transient reactions at the injection site; frequency unknown - peripheral edema.
Influence on the results of laboratory and instrumental studies: the frequency is unknown - a decrease in the concentration of cortisol in the blood plasma (clinical significance is unknown).
Long-term use in children with PWS
Benign, malignant and unspecified neoplasms: infrequently - leukemia (the frequency of development does not exceed that for children with growth hormone deficiency who do not receive somatropin therapy).
From the side of metabolism and nutrition: the frequency is unknown - the development of type 2 diabetes mellitus.
From the nervous system: the frequency is unknown - paresthesia, benign intracranial hypertension.
From the musculoskeletal system and connective tissue: often - arthralgia, myalgia; frequency unknown - skeletal muscle rigidity.
General disorders and disorders at the injection site: often - transient reactions at the injection site; frequency unknown - peripheral edema.
Influence on the results of laboratory and instrumental studies: the frequency is unknown - a decrease in the concentration of cortisol in the blood plasma (clinical significance is unknown).
Use in adults
Benign, malignant and unspecified neoplasms: infrequently - leukemia (the frequency of development does not exceed that for adult patients with growth hormone deficiency who are not receiving somatropin therapy).
From the side of metabolism and nutrition: the frequency is unknown - the development of type 2 diabetes mellitus.
From the nervous system: often - paresthesia; frequency unknown - benign intracranial hypertension, carpal tunnel syndrome.
From the musculoskeletal system and connective tissue: very often - arthralgia; often - myalgia, skeletal muscle rigidity.
General disorders and disorders at the injection site: very often - peripheral edema; frequency unknown - transient reactions at the injection site.
Influence on the results of laboratory and instrumental studies: the frequency is unknown - a decrease in the concentration of cortisol in the blood plasma (clinical significance is unknown).
Also described: the development of allergic reactions, including skin rash and itching; progression of scoliosis, epiphyseolysis of the femoral head, lameness, pain in the thigh, hip and knee joints; the formation of antibodies to somatropin, a decrease in the concentration of T4 and an increase in the concentration of T3 in the blood plasma; headache, insomnia; glycosuria.
There are reports of the development of papilledema, pancreatitis in children.
During post-marketing studies, there have been cases of sudden death in patients with PWS treated with somatropin, although a causal relationship has not been established.
Interaction
Somatropin can increase the clearance of drugs metabolized by microsomal isoenzymes of cytochrome P450 in the liver, especially those that are metabolized with the participation of the CYP3A4 isoenzyme - sex hormones, corticosteroids, antiepileptic drugs and cyclosporins, which can lead to a decrease in their concentration in blood plasma. The clinical significance of this effect has not yet been determined.
GCS inhibit the stimulating effect of somatropin on growth processes. The effectiveness of somatropin may be affected by concomitant therapy with other hormonal drugs, such as gonadotropin, anabolic steroids, estrogens and thyroid hormones.
Dosage and administration
S / c, slowly, 1 time per day (usually at night). To prevent the development of lipoatrophy, injection sites should be changed.
It is recommended to dissolve the contents of the vial in 1 ml of the supplied solvent (water for injection). To do this, the solvent is taken with a syringe and injected into the vial with the lyophilisate through the stopper.
Gently shake until the contents of the vial are completely dissolved. Do not shake. The resulting solution should be transparent and free of suspended particles. If the solution is cloudy or contains suspended particles, it should not be administered. The prepared solution is stored in a vial for no more than 2 weeks at a temperature of 2 to 8 ° C.
The dosage regimen is determined by the doctor individually, taking into account the severity of growth hormone deficiency, the weight or surface area of the patient's body, and is also adjusted depending on the effectiveness of the therapy.
Children
Indication
Daily dose
Note
mg/kg/day
mg/m2/day
Insufficient secretion of growth hormone 0.025–0.035 0.7–1 Treatment begins as early as possible and continues until puberty and/or closure of bone growth plates. It is possible to stop treatment when the desired result is achieved
Shereshevsky-Turner syndrome 0.045–0.05 1.4 -
PWV 0.035 1 The daily dose of the drug should not exceed 2.7 mg. Treatment should not be given to children with a height gain of less than 1 cm per year and with practically closed epiphyseal bone growth zones.
CRF 0.045–0.05 1.4 In case of insufficient growth dynamics, higher doses of the drug may be required. Revision of the optimal dose is possible after 6 months of treatment.
History of intrauterine growth retardation 0.035 1 Treatment should be discontinued if growth does not exceed 1 cm after the first year of treatment. Treatment should also be discontinued if growth does not exceed 2 cm per year and bone age is found to be >14 years for girls or >16 years for boys, or there are closed growth zones
adults
Treatment is recommended to start with a low dose - 0.15-0.3 mg (0.45-0.9 IU) / day, followed by a gradual increase depending on the concentration of IGF-I in the blood serum. In patients with a normal initial concentration of IGF-I, the dose of the drug should be selected so that the IGF-I value is on the upper limit of the norm, not going beyond 2 standard deviations from the mean.
The maintenance dose is selected individually and rarely exceeds 1.33 mg (4 IU) / day.
Women may need a higher dose than men because in men, an increase in sensitivity to IGF-I is observed over time. In this regard, women, especially those receiving oral estrogen replacement therapy, are at risk of receiving underdose somatropin treatment, while men may be receiving overdose somatropin treatment. The optimal dose of somatropin should be monitored every 6 months.
In patients over 60 years of age, therapy should begin with a dose of 0.1-0.2 mg / day, slowly increasing to the individually necessary. The lowest effective dose should be used.
Overdose
Symptoms: Acute overdose can lead to hypoglycemia followed by hyperglycemia. With prolonged overdose, there may be signs and symptoms characteristic of an excess of growth hormone - the development of acromegaly and / or gigantism, hypothyroidism, a decrease in serum cortisol levels. Cases of overdose are unknown.
Treatment: drug withdrawal, symptomatic therapy.
special instructions
insulin resistance
Somatropin can cause a state of insulin resistance, and in some patients - hyperglycemia, so patients should be monitored to identify signs of impaired glucose tolerance.
In rare cases, against the background of the use of somatropin, type 2 diabetes mellitus can develop, however, in most of these cases, patients initially had risk factors for developing diabetes mellitus - obesity, family history, taking corticosteroids, or a pre-existing impaired glucose tolerance.
In patients with pre-existing diabetes on the background of somatropin therapy, dose adjustment of hypoglycemic drugs may be required.
In children with an increased risk of developing diabetes mellitus (family history, obesity, severe insulin resistance, acanthoceratoderma), a glucose tolerance test should be performed.
Thyroid
In the treatment with somatropin, an increased conversion of thyroxine to triiodothyronine was revealed, which can lead to corresponding changes in the concentration of T3 and T4 in the blood plasma.
Theoretically, clinical manifestation of subclinical hypothyroidism is possible. Patients receiving levothyroxine sodium as hormone replacement therapy may develop hyperthyroidism.
It is recommended to monitor thyroid function after starting therapy with somatropin, as well as with each change in its dose.
Adrenal function
Somatropin reduces plasma cortisol levels, possibly by acting on carrier proteins or by increasing hepatic clearance. The clinical significance of this observation is unknown, however, corticosteroid replacement therapy should be optimized before the appointment of somatropin.
Neoplasms of the brain
In case of growth hormone deficiency that appeared after antitumor therapy, attention should be paid to possible signs of a recurrence of a brain tumor.
Epiphysiolysis of the femoral head
In patients with endocrine disorders, including growth hormone deficiency, displacement of the epiphyses of the femur may occur more often than in the general population. The detection of lameness during somatropin therapy requires clinical investigation and close monitoring.
Benign intracranial hypertension
In case of severe or recurrent headaches, visual disturbances, nausea and/or vomiting, a fundus examination (fundoscopy) is recommended to detect optic nerve edema, the presence of which suggests the possibility of intracranial hypertension. Initially, however, an increase in ICP may not be accompanied by papilledema. Thus, the absence of papilledema does not rule out intracranial hypertension. Upon confirmation of the diagnosis, it is necessary to stop therapy with somatropin. Currently, there are no guidelines for the use of somatropin in patients with corrected intracranial hypertension. However, the resumption of treatment with somatropin in many cases does not lead to relapse of intracranial hypertension. If the use of somatropin was resumed, then careful monitoring is necessary for the possible appearance of symptoms of intracranial hypertension.
Elderly age
Experience in people over 60 years of age is limited. Elderly patients may be more sensitive to the action of somatropin, and therefore they may be more prone to the development of adverse reactions.
FPV
Treatment with somatropin in patients with PWS should be accompanied by a calorie-restricted diet.
There have been reports of deaths with the use of somatropin in children with PWS who have at least one of the risk factors - severe obesity, a history of respiratory failure, sleep apnea, or respiratory tract infection. Thus, patients with PWS who have one or more of these factors may be at greater risk. Patients with PWS should be screened for these risk factors before somatropin is started. If obstruction of the upper respiratory tract is detected, treatment is necessary before starting the use of somatropin.
If a sleep apnea syndrome is suspected, the patient's condition should be carefully monitored.
If during treatment with somatropin signs of upper airway obstruction are observed, including the appearance or increase in snoring, treatment should be interrupted and the necessary examination should be carried out.
All patients with PWS should be monitored for sleep apnea and respiratory infections.
It is necessary to control the body weight of patients with PWS.
Scoliosis is a frequent occurrence in PWS, it can progress with the rapid growth of the body, therefore, during treatment with somatropin, it is necessary to monitor for possible signs of scoliosis. However, the use of somatropin does not increase the likelihood of development or severity of scoliosis.
Experience with long-term use in adults and patients with PWS is limited.
Stunted growth due to intrauterine growth retardation
In children diagnosed with growth retardation as a result of intrauterine growth retardation, other causes of stunting should be excluded before starting treatment. In children with this diagnosis, before starting treatment, fasting should determine the concentration of insulin and glucose in the blood plasma and conduct these studies annually. In children diagnosed with growth retardation as a result of intrauterine growth retardation, it is recommended to determine the concentration of IGF-I before starting treatment and then 2 times a year. If, during repeated measurements, the concentration of IGF-I exceeds 2 standard deviations relative to the typical ones, then the ratio of IGF-I to IRFSB-3 should be taken into account to adjust the dose of somatropin. The experience of therapy in children diagnosed with growth retardation as a result of intrauterine growth retardation during puberty is limited, so starting treatment during this period is not recommended. Experience in patients with Russell-Silverr syndrome is also limited.
If therapy is stopped before reaching the maximum possible age, part of the growth gain may be lost.
Growth disorders in CKD
The functional activity of the kidneys before the start of therapy with somatropin should be less than 50% of normal. Before treatment with somatropin for growth retardation due to CKD, patients should be followed up for one year to confirm growth failure.
Conservative treatment of renal insufficiency should be started, which should also be carried out during treatment with somatropin. During kidney transplantation, treatment with somatropin should be discontinued.
There are no data on the amount of growth gain when somatropin is used in patients with chronic renal failure.
Critical conditions
Mortality in adult patients treated with somatropin at a dose of 5.3 or 8 mg / day, who are in critical condition as a result of complications after open-heart and abdominal surgery, multiple injuries as a result of an accident, and acute respiratory failure, was higher, than in the placebo group (42 and 19%, respectively). In this regard, the use of the drug in these conditions is contraindicated.
Antibody formation
Approximately 1% of patients may develop antibodies to somatropin. The ability of these antibodies to interact is low, and they do not affect the growth rate. In all patients with a lack of response to therapy or a decrease in it, a study for the presence of antibodies to somatropin should be performed.
Pancreatitis in children
The risk of pancreatitis in pediatric patients receiving somatropin is increased. Despite the rarity of this complication, pancreatitis should be ruled out if abdominal pain occurs.
Leukemia
Cases of the development of leukemia in a small number of patients with growth hormone deficiency who received somatropin are described. The relationship between the occurrence of leukemia and somatropin therapy has not been established.
Transportation. In a place protected from light at a temperature of 2 to 8 ° C. Do not freeze. A single increase in temperature is allowed no higher than 25 ° C for no more than 24 hours.
Influence on the ability to drive vehicles and mechanisms
Jintropin® does not adversely affect the ability to drive vehicles and perform other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Release form
Lyophilisate for solution for subcutaneous administration, 4 IU, 10 IU.
Lyophilisate: 4 IU or 10 IU in a glass vial.
Solvent: 1 ml in a neutral glass ampoule with a break point.
5 vials with lyophilizate complete with 5 amp. with a solvent and 5 disposable syringes (volume 1 ml) are placed in a cardboard pack.
10 vials with lyophilisate complete with 10 amp. with a solvent is placed in a cardboard box.
20 vials with lyophilisate is placed in a cardboard box.
50 vials with lyophilizate complete with 50 amp. with a solvent is placed in a cardboard box.
Manufacturer
Genescience Pharmaceuticals Co., Ltd. 130012, China, Jilin Province, 72, Tianhe Street, Changchun, Hi-Tech Development Zone
or China, Jilin Province, 1718, Ueda Road, Changchun, High-Tech Development Zone.
Terms of dispensing from pharmacies
On prescription.
Storage conditions of the drug Jintropin®
In a place protected from light, at a temperature of 2-8 ° C (do not freeze). The prepared solution should be stored at a temperature of 2 to 8 °C for 2 weeks.
Keep out of the reach of children.
Shelf life of the drug Jintropin®
3 years. Solvent (water for injection) - 4 years.
Do not use after the expiry date stated on the packaging.
Pharmacokinetics
The duration of the drug action is 12-48 hours.
Indications for use
- growth retardation in children with growth hormone deficiency;
- with growth retardation;
- Prader-Willi syndrome;
- Shereshevsky-Turner syndrome ;
- with weight loss;
- postoperative tissue repair and healing of burns;
replacement therapy in adults.
Contraindications
- hypersensitivity to the drug
- brain ;
- closing epiphyses bones;
Used with caution when hypothyroidism And increased intracranial pressure .
Side effects
- weakness, fatigue ;
- increased intracranial pressure (manifested by nausea, vomiting, headache and visual impairment);
- development hypothyroidism ;
- hyperglycemia ;
- hyperemia , swelling and at the injection site, lipoatrophy (decrease in the volume of adipose tissue);
- destruction of the cartilage of the femoral head;
- skin rash ;
- fluid retention.
These reactions are transient, dose-dependent.
More rare side effects described in the literature: gynecomastia , optic disc, subluxation of the hip in children, hearing impairment, progression of scoliosis, accelerated growth and malignancy of a pre-existing nevus.
Application instruction of Dzhintropin (Way and dosage)
Jintropin is administered subcutaneously, at night, 1 time per day, changing injection sites (prevention of lipoatrophy). Dissolve the powder only in the supplied solvent by gently shaking or rotating the vial. Avoid sudden shaking. The resulting solution is clear. In the presence of turbidity or particles of undissolved drug, the solution is not used for injection.
Doses are selected taking into account the deficiency of growth hormone, so how to take and for how long, only an endocrinologist can recommend.
In children, the dose is 0.07-0.1 IU / kg / day. Treatment begins at an early age and spend several years until puberty (or until the closure of the epiphyses of tubular bones).
With Shereshevsky-Turner syndrome, as well as with renal failure with growth retardation - 0.14 IU / kg / day. In the second year of treatment, the dose is increased. With insufficient growth dynamics, the dose increases already in the first year of treatment.
In adults, treatment begins with 0.45-0.9 IU / day, increasing the dose depending on the effect.
Overdose
Overdose leads first to hypoglycemia , and then to hyperglycemia . With constant and prolonged overdose - development acromegaly , gigantism , hypothyroidism .
Interaction
Glucocorticoid drugs reduce the effect somatropin . The effectiveness of Jintropin is influenced by anabolic steroid, And thyroid hormones .
Terms of sale
Released by prescription.
Storage conditions
Storage temperature 2-8°C. Once prepared, the solution can be stored at 2–8°C for 2 weeks.
Best before date
Shelf life - 3 years.
special instructions
If the ongoing treatment does not give results, it is necessary to determine the titer of antibodies to somatropin, since there is a possibility of the formation of antibodies to the drug.
For prevention lipoatrophy at the injection site, each time you need to change the injection site.
Since there is a risk of developing hypothyroidism during treatment, thyroid hormones should be checked and corrected if necessary.
At diabetes it is necessary to control sugar in the blood and urine and adjust the treatment accordingly.
Conducting an examination of the fundus to detect edema of the optic nerve and intracranial hypertension.
The drug is prescribed for renal failure with a decrease in renal filtration by 50% or more. In parallel, the treatment of chronic renal failure is carried out.
The detection of lameness during treatment with Jintropin indicates the presence of epiphyseolysis of the bone heads, which requires careful monitoring.
Dzhintropin's analogs
Coincidence in the ATX code of the 4th level:Genotropin, Humatropin, Biosoma, Norditropin, Rastan, Somatropin, Ansomon .
Which is better: Ansomon or Jintropin?
Ansomon also represents recombinant human growth hormone containing 191 amino acids. It has the same indications for use and contraindications. If Jintropin is used more often for medical purposes, then Ansomon is used by athletes and individuals who want to improve their health and appearance. Ansomone is used for anti-aging therapy, accelerating fat burning, in order to increase and stimulate mental abilities. Unlike Jintropin, it burns fat more, retains less fluid.
Manufacturer Anhui Anke Biotechnology (Group) Co, Ltd. (China). The cost of Ansomon is 20% lower than that of Jintropin. Ansomon is an alternative to expensive American somotropin preparations. The course will cost an order of magnitude cheaper than therapy with American or European brands.
pharmachologic effect
The drug Jintropin ® is a genetically engineered somatotropic hormone. Stimulates skeletal and somatic growth, and also has a pronounced effect on metabolic processes. Stimulates the growth of skeletal bones, acting on the plates of the epiphysis of tubular bones, bone metabolism. Contributes to the normalization of body structure by increasing muscle mass and reducing body fat. In patients with growth hormone deficiency and osteoporosis, replacement therapy leads to the normalization of the mineral composition and bone density. Increases the number and size of muscle cells, liver, thymus, gonads, adrenal glands, thyroid gland. Stimulates the transport of amino acids into the cell and protein synthesis, reduces cholesterol levels by affecting the profile of lipids and lipoproteins. Suppresses the release of insulin. Promotes the retention of sodium, potassium and phosphorus. Increases body weight, muscle activity and physical endurance.
Pharmacokinetics
Suction and distribution
Absorption of somatropin after s / c administration is 80%, Cmax in blood plasma is achieved after 3-6 hours. It penetrates into well-perfused organs.
Metabolism and excretion
Metabolized in the kidneys and liver. V d somatropin - 0.49-2.11 l / kg. It is excreted by the kidneys and with bile (including 0.1% unchanged). T 1/2 after s / c injection is 3-5 hours.
Indications
- growth retardation in children due to insufficient secretion of growth hormone, with gonadal dysgenesis (Shereshevsky-Turner syndrome), with chronic renal failure (decrease in kidney function by more than 50%) in the prepubertal period;
- in adults with confirmed congenital or acquired deficiency of growth hormone as replacement therapy.
Dosing regimen
Jintropin ® is injected s / c, slowly, 1 time / day, usually at night. Injection sites should be changed to prevent the development of lyioatrophy.
It is recommended to dissolve the contents of the vial in 1 ml of the supplied solvent, based on the calculated dose. To do this, the solvent is taken with a syringe and injected into the vial with the drug through the stopper. Gently shake until the contents of the vial are completely dissolved. Sharp shaking is unacceptable. The prepared solution is stored in a vial for no more than two weeks at a temperature of 2°C to 8°C.
Doses are selected individually, taking into account the severity of growth hormone deficiency, weight or body surface area, and effectiveness in the course of therapy.
At children at
At
At growth hormone deficiency at adults the initial dose is 0.15-0.3 mg / day (which corresponds to 0.45-0.9 IU / day) with its subsequent increase, depending on the effect.
When titrating the dose, the level of insulin-like growth factor I (IGF-I) in the blood serum can be used as a control indicator. The maintenance dose is selected individually, but usually does not exceed 1 mg / day, which corresponds to 3 IU / day.
Side effect
Maybe: increased intracranial pressure (headache, nausea, vomiting, blurred vision), decreased thyroid function, hyperglycemia, leukemoid reactions, epiphysiolysis of the femoral head, fluid retention with the development of peripheral edema, arthralgia, myalgia, tunnel syndrome. Symptoms are usually transient, dose-dependent and may require dose reduction.
Allergic reactions: skin rash, itching.
Rarely: the formation of antibodies to the drug with a decrease in its effectiveness.
Local reactions: hyperemia, swelling, pain, itching, lipoatrophy at the injection site.
The following side effects are described in the literature with the use of the drug somatropin: weakness, fatigue, gynecomastia, papilledema (usually observed during the first 8 weeks of treatment, most often in patients with Szreshevsky-Turner syndrome), pancreatitis (abdominal pain, nausea, vomiting), otitis media and hearing impairment (in patients with Shereshevsky-Turner syndrome), hip subluxation in children (limping, pain in the hip and knee), acceleration of the growth of a pre-existing nevus (malignancy is possible), progression of scoliosis (in patients with excessively fast growth), increased blood levels of inorganic phosphate, parathyroid hormone and alkaline phosphatase activity.
Contraindications for use
- malignant neoplasms;
- active brain tumors;
- urgent conditions (including conditions after operations on the heart, abdominal cavity, acute respiratory failure);
- pregnancy;
- the period of breastfeeding (for the duration of treatment it is necessary to abandon breastfeeding);
- Hypersensitivity to the components of the drug.
WITH caution the drug should be prescribed for diabetes mellitus, intracranial hypertension, hypothyroidism.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Use in children
At children at inadequate secretion of growth hormone the recommended dose is 25-35 mcg/kg/day (0.07-0.1 IU/kg/day), which corresponds to 0.7-1 mg/m 2 /day (2-3 IU/m 2 /day). Treatment begins as early as possible and continues until puberty and/or closure of bone growth zones. It is possible to stop treatment when the desired result is achieved.
At Shereshevsky-Turner syndrome, with chronic renal failure in children, accompanied by growth retardation, the recommended dose is 50 mcg/kg/day (0.14 IU/kg/day) which corresponds to 1.4 mg/m 2 /day (4.3 IU/m 2 /day). With insufficient growth dynamics, dose adjustment may be required.
Overdose
Acute overdose may lead first to hypoglycemia and then to hyperglycemia. At prolonged overdose there may be signs and symptoms characteristic of an excess of human growth hormone - the development of acromegaly and / or gigantism, as well as the development of hypothyroidism, a decrease in the level of cortisol in the blood serum.
Treatment: drug withdrawal, symptomatic therapy.
drug interaction
GCS reduce the stimulating effect of somatropin on growth processes.
The effectiveness of the drug (in relation to final growth) can also be affected by concomitant therapy with other hormones, for example, gonadotropin, anabolic steroids, estrogens and thyroid hormones.
Terms of dispensing from pharmacies
The drug is dispensed by prescription.
Terms and conditions of storage
The drug should be stored in a place protected from light at a temperature of 2°C to 8°C. Do not freeze.
Store the prepared solution at a temperature of 2°C to 8°C for 2 weeks.
Keep out of the reach of children. Shelf life - 2 years. Do not use the drug after the expiration date.
Use in elderly patients
special instructions
Against the background of treatment with Jintropin ®, dosage adjustment of hypoglycemic drugs may be required in patients with diabetes mellitus, manifestation of latent hypothyroidism may occur, and signs of hyperthyroidism may appear in patients receiving thyroxine.
During treatment, it is necessary to monitor the condition of the fundus, especially with symptoms of intracranial hypertension. Edema of the optic nerve requires discontinuation of the drug.
The detection of lameness on the background of somatropin therapy requires careful monitoring.
It is necessary to change the places of s / c injections due to the possibility of developing lipoatrophy.
International name
Somatropin (Somatropin)Group affiliation
growth hormoneDosage form
Solution for subcutaneous administration, lyophilisate for solution for subcutaneous administrationpharmachologic effect
Genetically engineered growth hormone, acting on the plates of the epiphysis of tubular bones, stimulates the growth of skeletal bones. It activates the synthesis of chondroitin sulfate and collagen, increases the excretion of hydroxyproline, and contributes to an increase in body weight.
Regulates protein metabolism: stimulates the transport of amino acids into the cell and protein synthesis. Increases the number and size of muscle cells, hepatocytes, cells of the thymus, thyroid, adrenal glands and gonads.
Mobilizes fats: reduces the concentration of cholesterol and increases TG, reduces the volume of adipose tissue.
Retains Na +, K +, phosphorus and water in the body (prevents excretion); has anabolic (stimulates the transport of amino acids into the cell and protein synthesis), hyperglycemic effect (suppresses the release of insulin). Increased excretion of Ca2+ by the kidneys is compensated by its increased absorption in the gastrointestinal tract.
The duration of the therapeutic action is 12-48 hours.
Indications
Replacement therapy in childhood in patients with endogenous growth hormone deficiency (pituitary dwarfism), incl. against the background of chronic renal failure, Prader-Willi syndrome; Shereshevsky-Turner syndrome; replacement therapy for severe growth hormone deficiency in adults.
In the literature there are reports of the use of somatropin in the symptomatic treatment of the following diseases (indications not approved): kwashiorkor, osteoporosis, cachexia or significant weight loss in patients with AIDS.
Contraindications
Hypersensitivity, brain tumors, malignant tumors of any localization (acceleration of their growth is possible, treatment after effective antitumor therapy is possible), urgent conditions (including conditions after heart surgery, abdominal cavity, acute respiratory failure).Side effects
Headache, excessive fatigue or weakness, epiphyseolysis of the femoral head (limping, pain in the hip and knee), peripheral edema in the first weeks of treatment, arthralgia, myalgia, increased intracranial pressure (severe and frequent headaches, nausea, vomiting, blurred vision, swelling of the optic disc (usually observed during the first 8 weeks of treatment, most often in patients with Shereshevsky-Turner syndrome), pancreatitis (abdominal pain, nausea, vomiting), otitis media and hearing loss (in patients with Shereshevsky-Turner syndrome ), gynecomastia, tunnel syndrome, fluid retention, peripheral edema, leukemoid reactions, accelerated growth of a pre-existing nevus (malignancy is possible).Progression of scoliosis (in patients with excessively rapid growth).
Allergic reactions: skin rash, itching.
Local reactions at the injection site: soreness, numbness, hyperemia, swelling, lipoatrophy, itching.
In a small percentage of patients, the formation of antibodies to growth hormone with a decrease in its effectiveness.
Increased blood concentration of inorganic phosphate, parathyroid hormone and alkaline phosphatase activity.
Application and dosage
V / m, with low growth due to inadequate endogenous secretion of growth hormone - 12 IU / sq.m / week or 0.6 IU / kg / week; with inefficiency, the dose is increased to 20 IU / sq.m / week or up to 0.8 IU / kg / week. The weekly dose should be divided into 3-6 injections (4 IU/m2 or 0.2 IU/kg). Injections should be made in the evenings.
With insufficient growth in patients with gonadal dysgenesis (Turner syndrome) - 18 IU / sq.m / week or 0.6-0.7 IU / kg / week. In the second year of treatment, doses may be increased to 24 IU/m2/week or 0.8-1 IU/kg/week. The weekly dose of the drug should be divided into 7 single s / c injections of 2.6 IU / sq.m or 0.09-0.1 IU / kg.
In some cases, when treating patients with Turner's syndrome, it may be necessary to increase the doses already in the first year of treatment. Treatment is stopped when the patient reaches a height sufficient for an adult, or when the epiphyses of the tubular bones are closed.
The supplied NaCl solution is used to prepare the solution; for injection, a strictly required amount of the drug is collected, the remaining solution is discarded. After adding the solvent, it is necessary to carefully, without shaking, rotate the vial until the contents are completely dissolved. The resulting solution should be clear. If the solution is cloudy or contains particles of undissolved drug, it should not be used for injection.
Norditropin penset: with growth hormone deficiency - s / c, 0.07-0.1 IU / kg or 2-3 IU / sq.m 6-7 times a week. With Shereshevsky-Turner syndrome - s / c, 0.14 IU / kg or 4.3 IU / sq.m 6-7 times a week. With chronic renal failure in children, accompanied by growth retardation - s / c, 0.14 IU / kg or 4.3 IU / sq.m 7 times a week. The dry matter is dissolved with the supplied solvent.
Genotropin: the recommended dose is s / c, 0.5-0.7 IU / kg or 12-16 IU / sq.m per week. With Shereshevsky-Turner syndrome - 1 IU / kg or 30 IU / sq.m / week. In chronic renal failure in children, accompanied by growth retardation - 1 IU / kg or 30 IU / sq.m / week. After 6 months of therapy, a dose adjustment is necessary. Adults with severe growth hormone deficiency - 0.125-0.25 IU / kg per week. Dose selection is carried out depending on the effectiveness, adverse reactions, the concentration of insulin-like growth factor in the blood serum. Elderly patients are prescribed lower doses.
Biosome: with growth hormone deficiency in children - 0.6-0.7 IU / kg or 18 IU / sq.m of body surface per week. For patients receiving the drug for a long time, as well as for children during puberty - 1 IU / kg per week. With Shereshevsky-Turner syndrome - up to 1 IU / kg or 30 IU / sq.m per week. The recommended dose is divided into 6-7 injections and administered s / c in the evening. Better results are observed when treatment is given at an earlier age. Treatment is continued until puberty or until the closure of bone growth zones. It is possible to stop treatment when the desired growth is achieved. The drug is dissolved in the supplied solvent containing 0.9% benzyl alcohol: 4 IU - in 1.1 ml, 8 IU - in 2.1 ml. The volume of the solvent drawn into the syringe is injected into the vial, directing the jet of liquid onto the vessel wall and without affecting the drug. Shake the bottle with soft circular motions (do not shake!) until the drug is completely dissolved. Do not use solution that is cloudy or contains undissolved particles.
Humatrope: with growth hormone deficiency - 0.18 mg / kg or 0.54 IU / kg per week. The dose is divided into equal parts and administered for 3 or 6 days a week in / m or s / c. The maximum dose for replacement therapy is 0.1 mg / kg or 0.3 IU / kg 3 times a week. With Shereshevsky-Turner syndrome - s / c, 0.3-0.34 mg / kg or 0.9-1 IU / kg (24-28 IU / sq.m) per week. The weekly dose is divided into 6-7 injections, preferably at night.
Zomacton: the dose is set individually. The recommended dose is 0.5-0.7 IU/kg or 14.8-20.7 IU/sq.m per week. The weekly dose is divided into 6-7 s / c injections. The maximum dose is 0.81 IU/kg or 24 IU/sq.m per week. Treatment continues for several years.
Treatment of cachexia on the background of AIDS: patients weighing more than 55 kg - s / c, 18 IU (6 mg) at bedtime, 45-55 kg - 15 IU (5 mg), 35-44 kg - 12 IU (4 mg) , less than 35 kg - 0.1 mg / kg / day.
Rastan: s / c slowly, 1 time per day (usually at night). With insufficient secretion of growth hormone in children - 25-35 mcg / kg / day (0.07-0.1 IU / kg / day), which corresponds to 0.7-1 mg / sq.m / day (2-3 IU / sq.m / day ). With Shereshevsky-Turner syndrome, with chronic renal failure in children, accompanied by growth retardation - 50 mcg / kg / day (0.14 IU / kg), which corresponds to 1.4 mg / sq.m / day (4.3 IU / sq.m / day). With insufficient growth dynamics, dose adjustment is carried out. With growth hormone deficiency in adults, the initial dose is 0.15-0.3 mg / day (0.45-0.9 IU / day), followed by an increase depending on the effectiveness. When selecting a dose, insulin-like growth factor type 1 (IGF-1) in blood serum can be used as a control indicator. The maintenance dose is selected individually, but should not exceed 1 mg / day (3 IU / day). In the elderly, lower doses are recommended.
special instructions
Perhaps the formation of antibodies to the drug and proteins of Escherichia coli. A study of the titer of antibodies to somatropin should be carried out in cases where the patient does not respond to therapy.
Patients with growth hormone deficiency due to intracranial injury should be regularly monitored for progression or recurrence of the underlying disease.
In order to avoid atrophy of the subcutaneous adipose tissue at the injection site, it is necessary to change the injection site each time.
The possible occurrence of hypothyroidism during treatment should be corrected by the introduction of TSH to achieve the effect of increasing growth (control of thyroid function).
The drug is ineffective if low growth is due to the inability of the body to synthesize growth factors or the absence of receptors for liver growth factors - somatomedins, formed under the influence of somatropin. Treatment for insufficient secretion of growth hormone should begin as early as possible and continue until puberty and / or until the growth zones of the bones close, or when the desired result is achieved.
Patients with diabetes during treatment should be under strict medical supervision (control of glucose in the blood, urine); correction of hypoglycemic therapy is necessary.
Before and during treatment, in case of severe or recurring headaches, visual disturbances, nausea, vomiting, an examination of the fundus (fundoscopy) is recommended to detect edema of the optic nerve and associated intracranial hypertension. In this case, it is necessary to stop treatment.
With chronic renal failure, the drug is prescribed with a decrease in kidney function by more than 50%. Against the background of treatment, conservative treatment of chronic renal failure should be carried out. The drug should be discontinued after kidney transplantation. In patients with chronic renal failure, the development of renal osteodystrophy is possible, incl. accompanied by necrosis of the femoral head (more often observed in patients with concomitant endocrine pathology or excessively rapid growth).
Epiphysiolysis of the heads of tubular bones is more common in patients with endocrine disorders, including growth hormone deficiency. Detection of lameness during therapy requires careful monitoring.
Some dosage forms contain benzyl alcohol, which is toxic to newborns, as a preservative.