Genotropin is presented as a 2-compartment cartridge in a reconstitution device (kabi vial). The front part content recombinant somatropin 16 IU, glycine 2 mg, mannitol 41 mg, sodium dihydrogen phosphate anhydrous 0.29 mg and disodium phosphate 0.28 mg; and the rear part content m-cresol 3 mg and water for injection to 1 mL with reconstitution device.
When the cartridge is screwed together, the injection substance and solvent are automatically mixed.
Somatropin, a human growth hormone, is produced by recombinant DNA technology. Contents and sequence of amino acids are identical with human hypophyseal growth hormone.
Somatropin is synthesized in E. coli bacteria. The synthesis takes place via a prehormone consisting of growth hormone linked to a signal peptide occurring naturally in the bacterium. The prehormone is split in the inner cell wall of the bacterium, releasing growth hormone into the periplasmic space. Growth hormone is then harvested through careful disruption of the outer cell wall of the bacterium. The inner cell wall remains in principle intact.
Pharmacology: Somatropin promotes growth partly by stimulating somatomedin and protein synthesis.
Pharmacokinetics: In SC injection, approximately 80% is absorbed. Maximal plasma concentration is obtained after approximately 5 hrs. The half-life is approximately 4 hrs.
Growth disturbance caused by insufficient secretion of endogenous growth hormone, Turner syndrome, chronic renal insufficiency, born small for gestational age, Prader-Willi syndrome, and prepubertal idiopathic short stature. It is also indicated for replacement therapy in adults with growth hormone deficiency.
The dosage is individualized. Generally, a dose of 0.5-0.7 IU/kg body weight/week or 12 IU/m2/week divided into 6-7 SC injections is recommended. The injection site should be varied in order to avoid lipoatrophy.
Genotropin should be screwed together for reconstitution. Do not shake the solution during reconstitution.
Acute overdosage could initially lead to hypoglycaemia and subsequently to hyperglycaemia. Long-term overdosage could result in signs and symptoms of acromegaly consistent with the known effects of human growth hormone.
Genotropin should not be used when there is any evidence of activity of a tumor.
Intracranial lesions must be inactive and antitumor therapy completed prior to the institution of therapy.
Genotropin should be discontinued if there is evidence of tumor growth.
Patients with closed epiphysis and known hypersensitivity to m-cresol.
Acute catabolism, including pre- and postoperative treatment, critically ill patients and burn patients.
In growth hormone deficiency secondary to treatment of a malignant disease, it is recommended to pay attention to sign of relapse of the malignancy.
Patients with diabetes mellitus may require adjustment of their antidiabetic therapy.
It has been reported that some patients may develop hypothyroidism during growth hormone treatment which should be considered.
Therapy with Genotropin should be directed by physicians who are experienced in the diagnosis and management of patients with growth hormone deficiency.
Because human growth hormone may induce state of insulin resistance, patients should be observed of evidence of glucose intolerance.
Excessive glucocorticoid therapy may inhibit the growth-promoting effect of human growth hormone.
Patients with coexisting ACTH deficiency should have their glucocorticoid replacement dose carefully adjusted to avoid inhibitory effect on growth.
Hypothyroidism may develop during treatment with human growth hormone, and inadequate treatment of hypothyroidism may prevent optimal response to human growth hormone. Therefore, patients should have periodic thyroid function tests and be treated with thyroid hormone when indicated.
Patients with endocrine disorders, including growth hormone deficiency, may develop slipped capital epiphysis more frequently.
Any child with the onset of a limp during growth hormone therapy should be evaluated.
Clinical studies indicated that the treatment with Genotropin for the acute catabolism, including pre- and postoperative treatment, critically ill patients and burn patients, has been reported that the side effect of Jakob-Creutzfeld syndrome (subacute spongioform encephalopathy), which is a slow-virus disease in the central nervous system characterized by the progressive dementia, myoclonic convulsion which attacks adults and the elderly, and can cause death. Therefore, Genotropin is not recommended to use for those indications.
Note: The diagnosis of growth hormone deficiency should be verified before Genotropin is administered. This requires a thorough investigation of the pituitary function.
Use in pregnancy: Clinical experience of use in pregnant women is limited. Animal experimental data are incomplete. Therefore, Genotropin should be given to pregnant women only if clearly needed.
Use in lactation: Information is lacking on whether peptide hormones pass over into the breast milk, but absorption in the gastrointestinal tract of the infant of intact protein is extremely unlikely.
Caution should be exercised when Genotropin is administered to a nursing woman.
Use in pregnancy: Clinical experience of use in pregnant women is limited. Animal experimental data are incomplete. Therefore, Genotropin should be given to pregnant women only if clearly needed.
Use in lactation: Information is lacking on whether peptide hormones pass over into the breast milk, but absorption in the gastrointestinal tract of the infant of intact protein is extremely unlikely.
Caution should be exercised when Genotropin is administered to a nursing woman.
Reactions at the site of injection have been reported eg, itching, lumps, redness and lipoatrophy.
Genotropin has given rise to the formation of antibodies to growth hormone and
E. coli protein in a small number of patients.
The binding capacity of these antibodies has been low and without clinical significance. Investigation of eventful formation of antibodies should be performed if expected effect on the growth does not take place.
Leukemia has been reported in a small number of children who have been treated with growth hormone.
Corticosteroids may inhibit the growth-promoting effect of Genotropin.
Reconstituted solution may be stored in refrigerator for 3 weeks.
Store in cold place (2°-8°C). Protect from light.
H01AC01 - somatropin ; Belongs to the class of somatropin and somatropin agonists. Used in anterior pituitary lobe hormone and analogue preparations.
Genotropin GoQuick powd for inj 5.3 mg/mL
(pre-filled pen + solvent) 1's (Rp2,167,051/boks)
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