Recombinant Human Growth Hormone for Injection Instruction
Drug Name
●Generic Name: Recombinant Human Growth Hormone for Injection
●Trade name: Saizen® (Jintropin)
English name: Recombinant Human Growth Hormone for Injection
●Hanyu Pinyin： Zhusheyong Chongzu Ren Shengzhangjisu
Main components: Recombinant human growth hormone and excipient.
Molecular formula: C990H1528N262O300S7, a protein consisting of 191 amino acids
●Molecular weight: 22125D
This product is a white lyophilized powder
Indications
●For children with slow growth caused by endogenous growth hormone deficiency.
●For the treatment of severe burns.
●For growth hormone deficiency due to well-defined hypothalamic-pituitary disorders and significant growth hormone deficiency confirmed by two different growth hormone stimulation tests.
Specification
●2.5IU/0.85mg/1.0ml/bottle
●4.0IU/1.33mg/1.0ml/bottle
●4.5IU/1.7mg/1.0ml/bottle
●10IU/3.7mg/1.0ml/bottle
Dosage
The recommended dose for growth promotion in children varies from person to person. The recommended dose is 0.1-0.15IU/kg body weight/day, injected subcutaneously once a day for a period of 3 months to 3 years, or as prescribed by the doctor.
The recommended dose for severe burns is 0.2-0.4 IU/kg body weight/day, injected subcutaneously once a day. The duration of treatment is usually about 2 weeks.
●The dose for adult replacement therapy must be adjusted according to the individual. It is usually recommended to start with a low dose, such as 0.5 units per day (0.17 mg) or an amount as large as 0.02 units/kg body weight/day, equal to 0.007 mg/kg body weight/day; after one or two months of treatment results, the dose can be gradually adjusted to 0.04 units/kg body weight/day, equal to 0.013 mg/kg body weight/day. The level of insulin-like growth factor I (IGF-I) in serum can be used as a dose reference. The dose decreases with age.
[Adverse reactions].
● Growth hormone may cause transient hyperglycemia, which usually returns to normal with prolonged dosing or after discontinuation of the drug.
In clinical trials, 1% of children with short stature had side effects. Local transient reactions (pain, numbness, redness, swelling, etc.) and fluid retention (peripheral edema, arthralgia, or myalgia) at the injection site were common, and these side effects occurred early and the incidence decreased with prolonged dosing.
● Long-term injection of recombinant human growth hormone causes antibody production in a small number of patients with low antibody binding, which has no definite clinical significance, but if the expected growth effect is not achieved, there may be antibody production, and antibody binding above 2 mg/L may affect the efficacy.
【Contraindication】.
● Growth promotion therapy is contraindicated after the epiphysis has completely closed.
It is contraindicated in critically ill patients with severe systemic infections during the acute shock period of the organism.
Precautions
For use under medical supervision in patients with a clear diagnosis.
Dose adjustment of anti-diabetic drugs may be required in diabetic patients.
Concomitant use of corticosteroids can inhibit the growth-promoting effect of growth hormone. Therefore, patients with ACTH deficiency should have their corticosteroid dosage adjusted appropriately to avoid its inhibitory effect on growth hormone. (See Drug Interactions)
A small number of patients may develop hypothyroidism during growth hormone therapy, which should be corrected promptly to avoid affecting the efficacy of growth hormone. Therefore, patients should have regular thyroid function tests and be given thyroxine supplements if necessary.
Patients with endocrine disorders (including growth hormone deficiency) may experience slipped epiphyseal plates of the femoral head, and should be evaluated if claudication occurs during the growth hormone treatment period.
Sometimes growth hormone can lead to an over-insulinized state, so attention must be paid to whether the patient has a reduced glucose tolerance.
●Insulin therapy is required if blood glucose is higher than 10 mmol/L during the treatment period. If insulin of 150 IU/day or more is not effective in controlling blood glucose, the product should be discontinued.
●The injection site should be changed frequently to prevent fat atrophy.
Pregnant women and nursing mothers
It should not be used.
Use in children
There are no significant differences in the pharmacology and pharmacokinetics of growth hormone between children and adults, and it can be used safely according to body weight.
Medication for Elderly Patients
There are no systematic clinical studies on the use in the elderly.
Drug Interactions
Concomitant use of glucocorticoids may inhibit the response to hormones, so the dosage of glucocorticoids in growth hormone therapy should not exceed 10-15 mg of hydrocortisone/m2 body surface area. Concomitant use of non-androgenic steroids can further enhance growth rate.
Drug Overdose
No cases of acute overdose have been reported. However, exceeding the recommended dose can cause adverse reactions, and overdose may start with hypoglycemia followed by hyperglycemia. Long-term overdose may lead to signs and symptoms of acromegaly and other reactions associated with growth hormone overdose.
Pharmacology and Toxicology
Human growth hormone (hGH) is a 191-amino acid peptide hormone secreted by the growth hormone (GH) secretory cells in the anterior pituitary gland, which contains eosinophilic granules. This product is recombinant human growth hormone (rhGH) produced by recombinant E. coli secretory expression technology, and its amino acid content and sequence are identical to those of human growth hormone. It is synthesized in Escherichia coli (E. coli). The synthesis is carried out by means of a prehormone. The prehormone is composed of a growth hormone that is naturally present in the bacteria and is linked to a signal peptide. The prehormone divides in the inner cell wall of the bacteria, releasing an end-product identical to the natural growth hormone into the wall membrane gap, which is then collected by disrupting only the outer cell wall, while the inner cell wall remains intact to ensure minimal contamination of the end-product by bacterial protein.
Secretory recombinant human growth hormone (rhGH) has the same effect as human endogenous growth hormone, stimulating chondrocyte differentiation and proliferation at the epiphysis, stimulating chondrogenic stromal cell growth, stimulating osteoblast differentiation and proliferation, causing linear growth acceleration and bone widening. Promotes systemic protein synthesis, corrects negative nitrogen balance after surgery and other trauma, and corrects hypoproteinemia caused by severe infection and cirrhosis; stimulates immunoglobulin synthesis, stimulates lymph-like tissue, macrophages and lymphocytes proliferation, and enhances anti-infection ability; stimulates collagen cells synthesis of fibroblasts in burn wounds and surgical incisions, and macrophages division and proliferation, accelerates wound healing, promotes myocardial protein It also promotes myocardial protein synthesis, increases myocardial contractility, reduces myocardial oxygen consumption, regulates fat metabolism, lowers serum cholesterol and low-density lipoprotein levels; supplements growth hormone deficiency or lack, regulates fat metabolism, bone metabolism, heart and kidney function in adults.
Pharmacokinetics]
According to the literature, both subcutaneous or intramuscular administration are equally effective. subcutaneous injection usually results in higher serum GH concentrations than intramuscular injection, but the resulting insulin-like growth factor I (IGF-I) concentrations are consistent. GH absorption is usually slow, with plasma GH concentrations usually peaking 3-5 hours after administration; clearance half-life is usually 2-3 hours, and GH is cleared by GH is cleared by the liver and kidneys, and more rapidly in adults than in children; the direct elimination of unmetabolized GH from the urine is extremely small.
Almost all GH in the circulation is bound to a high-affinity GH-binding protein (hGHBP), and this complex allows the half-life of GH in serum to be prolonged; the choice of time of day for injection does not affect the concentration of GH in serum.
[Expiration date
●24 months
Storage
Store and transport at 2~8℃ to avoid light, 7 days at room temperature, dissolved solution can be refrigerated at 2~8℃ for 72 hours.
Package】
Glass bottle of controlled antibiotics; 10 bottles/box