1. Name of the medical product
Fitropin (recombinant human growth hormone (rHGH), Somatropin (rDNA origin)) for injection 6iu
2. Description
Fitropin (rHGH is a human growth hormone produced by recombinant DNA technology. Its 191 amno acid sequence and structure are identical to the dominant form of the human pituitary growth hormone. It has a molecular with of 22,125 daltons. Fitropin (rHGH is a sterile, non-pyrogenic, white lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with sterile water for injection (.9% benzyl alcohol). The reconstituted solution should be ph of 6.5 to 8.5.
3. Pharmaceutical form
Powder for injection prepared with supplied solvent, with or without preservative, for subcutaneous administration.
4. Clinical pharmacology
General:
Linear growth-Fitropin stimulates linear growth in pediatric patients who lack adequate normal endogenous growth hormone. In vitro, preclinical, and clinical testing have demonstrated that Fitropin is therapeutically equivalent to human growth hormone of pituitary origin and achieves equivalent pharmacokinetic profiles in normal adults. Treatment of growth hormone deficient pediatric patients and patients with Turner syndrome with Fitropin produces increased growth rate and IGF-1 concentrations similar to those seen after therapy with human growth hormone of pituitary origin.
A. Tissue Growth- 1. Skeletal Growth: Fitropin stimulates skeletal growth in pediatric patients with growth hormone deficie4ncy. The measurable increase in body length after administration of either Fitropin or human growth hormone of pituitary origin results from an effect on the growth plates of long bones. Concentrations of IGF 1, which may play a role in skeletal growth, are low in the serum of growth hormone deficient pediatric patients but increase during the treatment with Fitropin. Elevations in mean serum alkaline phosphates concentrations are also seen. 2. Cell Growth: It has been shown that there are fewer skeletal muscle cells in 3 short stature pediatric patients who lack endogenous growth hormone as compared with normal pediatric populations. Treatment with human growth hormone of pituitary origin results in an increase in both the number and size of muscle cells.
B. Protein metabolism-Linear growth is facilitated in part by increased cellular protein synthesis. Nitrogen retention, as demonstrated by decreased urinary nitrogen excretion and serum urea nitrogen, follows the initiation of therapy with human growth hormone of pituitary origin. Treatment with Fitropin results in a similar decrease in serum nitrogen.
C. Carbohydrate metabolism-pediatric patients with hypo-pituitaryism sometimes experience fasting hypoglycemia that is improved by treatment with Fitropin. Large doses of human growth hormone may impair glucose tolerance. Untreated patients with Turner syndrome resulted in increases in mean serum fasting and postprandial insulin levels although mean values remained in the normal range. In addition, mean fasting and postprandial glucose and hemoglobin A1C levels remained in the normal range.
D. Lipid metabolism-In growth hormone deficient patients, administration of human growth hormone of pituitary origin has resulted in lipid mobilization, reduction in body fat stores, and increased plasma fatty acids.
E. Mineral Metabolism-Retention of sodium, potassium, and phosphorus is induced by human growth hormone of pituitary origin. Serum concentrations of inorganic phosphate increased in patients with growth hormone deficiency after therapy with Fitropin or human growth hormone of pituitary origin. Serum calcium is not significantly altered in patients treated with either human growth hormone of pituitary origin or Fitropin,
5. Pharmacokinetics:
It is reported that the equal pharmacological effect could be achieved via subcutaneous or intramuscular administration. Even though SC could lead to a higher concentration of GF in plasma, IM could also yield the same IGF 1 levels. The absorption of rHGH is relatively slow. Cmax often occur at 3-5 hours after injection. Clearance of rHGH is via liver and kidneys, the half life of clearance is about 2 to 3 hours, the intact rHGH excreted in urea is almost immeasurable. All of the rHGH in circulation system exists as a complex form with GH binding protein that make the half life of rHGH prolonged. Different administration time in a day does not affect the blood rHGH concentration. For the sake of such a fact that the rHGH peak concentration often appears during slow wave sleeping in normal physiological state, injection just before going to bed should be the best choice.
6. Contraindications
Fitropin should not be used for growth promotion in pediatric patients with closed epiphyses. Fitropin should not be sued in patients with active neoplasia. GH therapy should be discontinued if evidence of neoplasia develops. Fitropin should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental traumas or to patents having acute respiratory failure.
7. Indications
Fitropin rHGH is indicated for the growth failure due to endogenous growth hormone deficiency. In recent years it is widely used in the treatment to the burned and preservation for human aging.
8. Dosage and administration
Fitropin rhgh dosage and schedule of administration should be individualized for each patient by a physician’s endorsement with expertise in the field of hormone replacement therapy. The recommended dosage is .1 iu per kg of body weight daily, with subcutaneous administration right before bed. Do not shake because Fitropin is a protein shaking can result in a cloudy solution. The Fitropin solution should be clear immediately after reconstitution. Do not inject Fitropin if the constituted product is cloudy immediately after reconstitution.
9. Adverse reactions
Growth hormone may cause transient hyperglycemia; it can be recovered as the administration proceeded or terminated. Adverse reactions occurred in about 1% short stature children in clinical trial. Common adverse reactions include slight pain, tingle, turgescence around the injection site and peripheral edema, arthlgias. All of those adverse reactions often occurred at the beginning of treatment, and were temporal and tolerable. Long term and high dosage administration of rhgh may develop the antibodies in a few patients. However, the antibodies concentration could be rarely up to as high as 2mg/L that might affect the therapeutic efficiency.
10. Warnings and Precautions
1. rhgh therapy should be conducted on exactly diagnosed GHD patients under advice of experienced doctor.
2. For diabetes patients, dosage of anti glucourea drugs should be adjusted during rhgh therapy.
3. For patients whose GHD were caused by encephala or encephalic wound, the progress and relapse possibility of potential diseases should be closely monitored.
4. For ACTH deficiency patients, dosage of ATCH should be adjusted because the growth improvement effect of rhgh could be inhibited by simultaneous using of ACTH.
5. Thyroid gland function should be tested regularly because clinical hypothyroidism may occur to some patients during rhgh therapy. For those hypothyroid, thyroid supplementation is necessary for ensuring the therapeutic effects of rhgh.
6. Careful consideration should be taken if claudicating occurred during rhgh therapy because the patients who suffered from endocrine system diseases have such a tendency that their epiphysis plates of femur are relatively easy to separate.
7. Growth hormone may lead to over insulin state, attention should be paid to if lower glucose intolerance appeared.
8. Do not take over dose of rhgh, one time over dose rhgh administration can lead to low blood sugar and succeeded with high blood sugar. Long term over dose rhgh administration can lead to acromegaly. ( see the top professional body builders faces)
9. Injection site should often be changed in case lipoatrophy.
11. Pregnancy and lactation
No clinical experience of the using in pregnant and nursing women to accept rhgh therapy.
12 Pediatric use
Fitropin is safe.
13. Old patients use
Fitropin is safe
14 Interactions with other drugs
Simultaneous use of non-androgenic steroids during rhgh administration can accelerate growth rate.
17 Storage
Keep at 2-8degreesC away from light. The reconstituted solution can be stored at 2-8 degrees C for 48 hours, with preservative for 14 days, avoid freezing.
18 Shelf life
24 months at 2-8 degrees C
Fitropin (recombinant human growth hormone (rHGH), Somatropin (rDNA origin)) for injection 6iu
2. Description
Fitropin (rHGH is a human growth hormone produced by recombinant DNA technology. Its 191 amno acid sequence and structure are identical to the dominant form of the human pituitary growth hormone. It has a molecular with of 22,125 daltons. Fitropin (rHGH is a sterile, non-pyrogenic, white lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with sterile water for injection (.9% benzyl alcohol). The reconstituted solution should be ph of 6.5 to 8.5.
3. Pharmaceutical form
Powder for injection prepared with supplied solvent, with or without preservative, for subcutaneous administration.
4. Clinical pharmacology
General:
Linear growth-Fitropin stimulates linear growth in pediatric patients who lack adequate normal endogenous growth hormone. In vitro, preclinical, and clinical testing have demonstrated that Fitropin is therapeutically equivalent to human growth hormone of pituitary origin and achieves equivalent pharmacokinetic profiles in normal adults. Treatment of growth hormone deficient pediatric patients and patients with Turner syndrome with Fitropin produces increased growth rate and IGF-1 concentrations similar to those seen after therapy with human growth hormone of pituitary origin.
A. Tissue Growth- 1. Skeletal Growth: Fitropin stimulates skeletal growth in pediatric patients with growth hormone deficie4ncy. The measurable increase in body length after administration of either Fitropin or human growth hormone of pituitary origin results from an effect on the growth plates of long bones. Concentrations of IGF 1, which may play a role in skeletal growth, are low in the serum of growth hormone deficient pediatric patients but increase during the treatment with Fitropin. Elevations in mean serum alkaline phosphates concentrations are also seen. 2. Cell Growth: It has been shown that there are fewer skeletal muscle cells in 3 short stature pediatric patients who lack endogenous growth hormone as compared with normal pediatric populations. Treatment with human growth hormone of pituitary origin results in an increase in both the number and size of muscle cells.
B. Protein metabolism-Linear growth is facilitated in part by increased cellular protein synthesis. Nitrogen retention, as demonstrated by decreased urinary nitrogen excretion and serum urea nitrogen, follows the initiation of therapy with human growth hormone of pituitary origin. Treatment with Fitropin results in a similar decrease in serum nitrogen.
C. Carbohydrate metabolism-pediatric patients with hypo-pituitaryism sometimes experience fasting hypoglycemia that is improved by treatment with Fitropin. Large doses of human growth hormone may impair glucose tolerance. Untreated patients with Turner syndrome resulted in increases in mean serum fasting and postprandial insulin levels although mean values remained in the normal range. In addition, mean fasting and postprandial glucose and hemoglobin A1C levels remained in the normal range.
D. Lipid metabolism-In growth hormone deficient patients, administration of human growth hormone of pituitary origin has resulted in lipid mobilization, reduction in body fat stores, and increased plasma fatty acids.
E. Mineral Metabolism-Retention of sodium, potassium, and phosphorus is induced by human growth hormone of pituitary origin. Serum concentrations of inorganic phosphate increased in patients with growth hormone deficiency after therapy with Fitropin or human growth hormone of pituitary origin. Serum calcium is not significantly altered in patients treated with either human growth hormone of pituitary origin or Fitropin,
5. Pharmacokinetics:
It is reported that the equal pharmacological effect could be achieved via subcutaneous or intramuscular administration. Even though SC could lead to a higher concentration of GF in plasma, IM could also yield the same IGF 1 levels. The absorption of rHGH is relatively slow. Cmax often occur at 3-5 hours after injection. Clearance of rHGH is via liver and kidneys, the half life of clearance is about 2 to 3 hours, the intact rHGH excreted in urea is almost immeasurable. All of the rHGH in circulation system exists as a complex form with GH binding protein that make the half life of rHGH prolonged. Different administration time in a day does not affect the blood rHGH concentration. For the sake of such a fact that the rHGH peak concentration often appears during slow wave sleeping in normal physiological state, injection just before going to bed should be the best choice.
6. Contraindications
Fitropin should not be used for growth promotion in pediatric patients with closed epiphyses. Fitropin should not be sued in patients with active neoplasia. GH therapy should be discontinued if evidence of neoplasia develops. Fitropin should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental traumas or to patents having acute respiratory failure.
7. Indications
Fitropin rHGH is indicated for the growth failure due to endogenous growth hormone deficiency. In recent years it is widely used in the treatment to the burned and preservation for human aging.
8. Dosage and administration
Fitropin rhgh dosage and schedule of administration should be individualized for each patient by a physician’s endorsement with expertise in the field of hormone replacement therapy. The recommended dosage is .1 iu per kg of body weight daily, with subcutaneous administration right before bed. Do not shake because Fitropin is a protein shaking can result in a cloudy solution. The Fitropin solution should be clear immediately after reconstitution. Do not inject Fitropin if the constituted product is cloudy immediately after reconstitution.
9. Adverse reactions
Growth hormone may cause transient hyperglycemia; it can be recovered as the administration proceeded or terminated. Adverse reactions occurred in about 1% short stature children in clinical trial. Common adverse reactions include slight pain, tingle, turgescence around the injection site and peripheral edema, arthlgias. All of those adverse reactions often occurred at the beginning of treatment, and were temporal and tolerable. Long term and high dosage administration of rhgh may develop the antibodies in a few patients. However, the antibodies concentration could be rarely up to as high as 2mg/L that might affect the therapeutic efficiency.
10. Warnings and Precautions
1. rhgh therapy should be conducted on exactly diagnosed GHD patients under advice of experienced doctor.
2. For diabetes patients, dosage of anti glucourea drugs should be adjusted during rhgh therapy.
3. For patients whose GHD were caused by encephala or encephalic wound, the progress and relapse possibility of potential diseases should be closely monitored.
4. For ACTH deficiency patients, dosage of ATCH should be adjusted because the growth improvement effect of rhgh could be inhibited by simultaneous using of ACTH.
5. Thyroid gland function should be tested regularly because clinical hypothyroidism may occur to some patients during rhgh therapy. For those hypothyroid, thyroid supplementation is necessary for ensuring the therapeutic effects of rhgh.
6. Careful consideration should be taken if claudicating occurred during rhgh therapy because the patients who suffered from endocrine system diseases have such a tendency that their epiphysis plates of femur are relatively easy to separate.
7. Growth hormone may lead to over insulin state, attention should be paid to if lower glucose intolerance appeared.
8. Do not take over dose of rhgh, one time over dose rhgh administration can lead to low blood sugar and succeeded with high blood sugar. Long term over dose rhgh administration can lead to acromegaly. ( see the top professional body builders faces)
9. Injection site should often be changed in case lipoatrophy.
11. Pregnancy and lactation
No clinical experience of the using in pregnant and nursing women to accept rhgh therapy.
12 Pediatric use
Fitropin is safe.
13. Old patients use
Fitropin is safe
14 Interactions with other drugs
Simultaneous use of non-androgenic steroids during rhgh administration can accelerate growth rate.
17 Storage
Keep at 2-8degreesC away from light. The reconstituted solution can be stored at 2-8 degrees C for 48 hours, with preservative for 14 days, avoid freezing.
18 Shelf life
24 months at 2-8 degrees C
