Erythropoietin (EPO) is a glycoprotein hormone of 34–38 kDa which stimulates proliferation and differentiation of erythroid precursor cells (CFU-E, BFU-E) to more mature erythrocytes. EPO is primarily produced in adult kidney and fetal liver cells. Cells responsive to EPO have been identified in adult bone marrow, fetal liver or adult spleen. In cultures of erythropoietic progenitor cells, EPO stimulates the proliferation and differentiation of these cells to more mature red blood cells.
Erythropoietin (EPO) regulates the level of erythrocytes in response to the level of oxygen in the blood. When tissues meet hypoxic conditions, the EPO level in the blood increases, and the elevated EPO level triggers differentiation of progenitor cells in bone marrow and release of erythrocytes from bone marrow into the blood.
Native human erythropoietin was originally prepared from urine of patients with aplastic anemia. The amount of human erythropoietin obtained from the patient's urine is rare, and a traditional process for purifying the human erythropoietin is laborious and time-consuming. Therefore, there is a demand to develop a process for producing and purifying a large amount of human erythropoietin in a simple and economical way.
Genetic engineering techniques using an mammalian cell line as a host for producing a high level of recombinant human erythropoietin (rhEPO) has been developed. A cDNA fragment encoding human erythropoietin was cloned and sequenced by Jacob et al. (Nature, 313: 806-809, 1985). we use the gene recombinant technology to extract the recombinant EPO, thus making it possible for mass and cost effective production. In addition, its in vivo and in vitro biological activity makes no difference from the natural EPO.
SEPO® recombinant human erythropoietin injection, which stimulates red blood cell production, is a 165 amino acid glycoprotein manufactured by recombinant DNA technology. It is produced by CHO (Chinese Hamster Ovary) cell into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological effects as endogenous erythropoietin.
 
Description: Clear colorless and transparent. pH 6.9±0.3
Composition: rhEPO, citric acid buffer solution and human serum albumin as stabilizer
Indications
Treatment of anemia of chronic renal failure patients, including patients on dialysis and patients not on dialysis
Treatment of anemia in cancer patients on chemotherapy
Reduction of allogeneic blood transfusion in surgery patients
Usage and Dosage (for treatment of renal anemia)
SEPO® should be used under instruction of physicians. It may be administrated subcutaneously or intravenously, 2-3 times per week. The dosage should be adjusted according to the severity of anemia, age and other related factors. The following dosage is for reference:
Treatment period: The initial dose is 100-150IU/kg per week for patients on hemodialysis and 75-100 IU/kg for patients not on hemodialysis. If hematocrit increases less than 0.5vol% weekly the dose can be increased by 15-30IU/kg 4 weeks after the initial dose, but the increased maximum dose is not more than 30IU/kg /week. The hematocrit should be increased within the range of 30-33vol%, but not higher than 34vol%.
Maintenance period: When hematocrit has reached to 30-33vol% or hemoglobin has reached to 100-110g/l, maintenance period starts. The dosage in this period shall be adjusted to the 2/3 of the recommended dosage in the treatment period. The hematocrit shall be monitored once every 2-4 weeks to adjust the dosage so as to maintain the hematocrit and hemoglobin at the proper level, at the same time to avoid erythropoiesis too quickly.
Intravenous administration is recommended for patients on hemodialysis and subcutaneous administration for patients on peritoneal dialysis and not on dialysis.
Contraindications
SEPO® is contraindicated in patients with:
Uncontrolled hypertention
Known hypersensitivity to mammalian cell-derived products
Known hypersensitivity to human albumin
Specifications
Single-dose, preservative-free vial. Each 1 ml of solution contains 2000IU, 2500IU, 3000IU, 4000IU, 5000IU or 10,000IU per vial.
Storage
Stored at 2-8℃ and protected from light. Do not freeze and shake
Shelf Life: Two years
Confirmed, Marked Clinical Effectiveness
Phase II clinical trial sites:
Beijing Friendship Hospital of Capital Medical University
PLA 301 Hospital, Nanjing Military General Hospital, Xinqiao Hospital of Third Military Medical University, Union Hospital of Tongji Medical University, Affiliated Hospital of Kunming Medical College, Affiliated Hospital of Jiangxi Medical College
Phase II clinical trial results:
The total effective rate of SEPO® for treatment of renal anemia is 96.8%
Pairs-matching comparative study indicated that SEPO® has similar effectiveness to imported rhEPO (ESPO®, Kirin Pharmaceutical, Japan) (see figure below)
Clinical study conducted in India for the purpose of registration
Study sites:
K.E.M. Hospital & Research Centre, Pune
Muljibhai Patel Kidney Hospital, Nadiad
Sir H.N. Hospital & Research Centre, Mumbai
Bombay Hospital, Mumbai
Conclusion:
SEPO® rhEPO was remarkably effective in the treatment of anemia associated with chronic renal failure and displayed excellent clinical tolerability and acceptability.
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