Date of approval: August 6, 2007
Date of revision: November 14, 2017
Human Growth Hormone for Injection (rhGH)
Please read the package insert carefully and follow the
guidance of the physician
name: Recombinant Human Growth Hormone for
Brand name: Sinotropin
The active ingredient is the recombinant human growth hormone, which is composed of 191 amino acids with a molecular
weight of 22,125 Da.
The excipients consist of glycine 0.68 mg, mannitol 18 mg, and a
moderate amount of sodium dihydrogen phosphate and sodium hydrogen phosphate.
The drug is white lyophilized powder.
The drug is indicated for children
with growth failure due to the endogenous growth hormone deficiency (GHD).
1.0mg(2.5IU) /vial, 1.6mg(4IU)
/vial, 3.2mg(8IU) /vial
【DOSAGE & ADMINISTRATION】
The lyophilized rhGH is dissolved
in the attached 1 ml sterilizing water for injection. Shake slightly to
dissolve the powder. The solution should be clear liquid. Do not use the product
if the solution is muddy or has particles. Avoid violent oscillation.
The dose is different from person to person.
The recommended dose for subcutaneous injections is 0.1IU/kg/d.
The subcutaneous injection should be administered at bedtime daily, or as directed
by the doctor's advice. The injection site should be changed frequently to
avoid injection site fat atrophy.
Growth hormone can cause the transient
hyperglycemia, which usually returns normal after the extended treatment or treatment
termination. Clinical trials showed side effects in 1% of children with short
stature. The most common adverse reactions are injection site reactions (e.g.
pain, numbness, redness, and swelling) and fluid retention (e.g. peripheral
edema, arthralgia, or myalgia). These side effects occur in the earlier stage
of the treatment and rarely influence the daily activities. The frequency of
side effects reduces over time.
Injecting the recombinant human
growth hormone for a long time will form antibodies in a minority of patients but
the antibody binding force is low, indicating no exact clinical significance. Antibodies
may be produced if the expected growth effect is not achieved. If the antibody
binding force is more than 2 mg/L, it may affect the efficacy of the treatment.
drug should not be used in pediatric patients with closed epiphyses.
drug should not be used in patients with symptoms of tumor progression.
drug should not be used in critical patients with severe systematic
inflammation during the acute shock period.
drug should be used in patients with definitive diagnosis under the guidance of
patients may need to adjust the anti-diabetic drug doses.
with growth hormone deficiencies caused by brain tumor or patients with a
history of intracranial injury must be closely monitored for the possibility of
potential disease progression or recurrence.
simultaneous use of the recombinant human growth hormone and the glucocorticoid
may inhibit the growth promoting effect of the growth hormone. Thus, the
patients lack of the adrenocorticotropic hormone (ACTH) should adjust the
dosage of the cortical hormone to avoid its inhibitory effect on the growth
the treatment period, few patients may develop hypothyroidism, which should be
timely treated to avoid negative impacts on the efficacy of growth hormone. Therefore,
patients should check thyroid function regularly and take thyroxine supplement when
with endocrine disorders, including the growth hormone deficiency, are likely
to suffer from the femoral epiphyseal plate slippage. Patients who appear to
walk with a limp during the treatment period should be further assessed.
hormone can sometimes lead to excessive insulin secretion. Therefore, attentions
must be paid to whether the patients have decreased glucose tolerance.
overdose. An excessive injection of growth hormone can cause a low blood sugar,
followed by a high blood sugar. A long-term excessive injection can lead to
symptoms and signs of acromegaly and other reactions associated with excess
sites should be changed frequently to prevent injection site fat atrophy.
10. Athletes should
use in caution.
【FOR PREGNANT AND
LACTACTING WOMEN PATIENTS】 Pregnant and lactating female patients should not use the drug.
The recommended dose for
hypodermic injection is 0.1IU/kg/d, or as directed by the doctor's advice.
The simultaneous use of the recombinant
human growth hormone and the glucocorticoid may inhibit hormone responses, thus,
the dosage of the glucocorticoid during the recombinant human growth hormone therapy
should not be more than 10 ~ 15 mg hydrocortisone/m2 body surface
The use of androgenic steroids can
further increase the growth rate.
Avoid overdose. An excessive
injection of growth hormone can cause a low blood sugar, followed by a high
blood sugar. Long-term excessive injection can lead to symptoms and signs of
This recombinant human growth
hormone (rhGH) has the same effect of the human growth hormone (hGH), which can
cause the tibia growth, cartilage growth, and weight gain in pituitary-removed
According to the mouse acute
toxicity study results, no death is observed when the dose is up to 400 times the
clinical recommended dosage.
When giving the rats rhGH
subcutaneously for 30 days, the results show that except weight gain all other
parameters are within the normal ranges, when the dose is up to 50 times the clinical
dosage. No pathological and histological changes are observed.
The results of the mutagenic test
(Ames test), reproductive toxicity test, delayed-type hypersensitivity test are
According to the literature, subcutaneous
and intramuscular injection have the same effect of drug delivery. Subcutaneous
injection can lead to a higher serum GH concentration than that of the intramuscular
injection, but the concentrations of IGF-1 are similar. Generally, the
absorption of GH is slower, with a Tmax of 3-5 hours and an
elimination half life of 2-3 hours. GH is metabolized and eliminated by the liver
or kidney. The clearance of GH is faster in adults than in children. The amount
of GH directly excreted by urine is extremely small.
In the blood circulation, GH binds
to the high-affinity GH binding protein (GHBP), resulting in an extended plasma
half-life of GH. Different injection times will not affect the concentration of
serum GH. However, the drug is usually injected at bedtime to simulate the natural
physiological changes of GH secretion (GH level peaks at night).
Preserve in well closed containers, protected from light and stored
at a temperature of 2℃ to 8℃.
Tube vial, 10 vials/ box
Pharmacopeia of China, 2015 edition, volume Ⅱ.
GUOYAOZHUNZI S20053035, GUOYAOZHUNZI S20053036,
Name: Zhongshan Sinobioway Hygene Biomedicine Co.,
Add: No.16 Shengwugu Road, Torch Development Zone, Zhongshan,
Guangdong, 528437, China.