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Recombinant human erythropoietin injection (CHO cells)

Function and Efficacy

Erythropoietin (EPO) is an active glycoprotein secreted by the kidneys. It acts on erythroid hematopoietic progenitor cells in the bone marrow and promotes their proliferation and differentiation. This product is recombinant human erythropoietin (rhEPO). Compared with natural products, its biological effects are basically the same in vivo and in vitro. Pharmacodynamic tests have shown that this product can increase the colony formation rate of erythroid hematopoietic progenitor cells (CFU-E) and has a significant therapeutic effect on anemia caused by chronic renal failure.

Ingredients

Main ingredients: Each recombinant human erythropoietin injection contains recombinant human erythropoietin, protein activity stabilizer and buffered saline solution. Recombinant Human Erythropoietin (Pregnancy Grade: C).

Name Description Content CAS NO. Manufacturer
EPOETIN ALFAIngredients

Erythropoietin (EPO) is an active glycoprotein secreted by the kidneys, which acts on erythroid hematopoietic progenitor cells in the bone marrow and promotes their proliferation and differentiation. This product can increase the colony formation rate of erythroid hematopoietic progenitor cells (CFU-E) and has a significant therapeutic effect on anemia caused by chronic renal failure.

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113427-24-0 1

Appearance

This product is a colorless transparent liquid.

Indication

1. Anemia caused by renal insufficiency, including dialysis and non-dialysis patients. 2. Red blood cell mobilization during perioperative period of surgery. 3. Anemia caused by chemotherapy in the treatment of non-bone malignant tumors. It is not used to treat anemia caused by other factors (such as iron or folate deficiency, hemolysis or gastrointestinal bleeding) in cancer patients.

Usage and Dosage

1. Renal anemia: It should be used under the guidance of a doctor. It can be injected subcutaneously or intravenously, divided into 2-3 doses per week, or it can be administered once a week. The dosage and frequency of administration need to be adjusted according to the patient's anemia degree, age and other related factors. The following scheme is for reference: Treatment period: divided administration every week: The recommended initial dose is 100-150 international units (IU)/kg body weight per week for hemodialysis patients and 75-100 IU/kg body weight per week for non-dialysis patients. If the hematocrit increases by less than 0.5 vol% per week, the dose can be increased by 15-30 IU/kg body weight after 4 weeks, but the maximum increase dose should not exceed 30 IU/kg body weight/week. The hematocrit should be increased to 30-33 vol%, but should not exceed 36%. Single administration per week: The recommended dose is 10,000 international units (IU) per week for adult hemodialysis or peritoneal dialysis patients. Maintenance phase: If the hematocrit reaches 30-33% or the hemoglobin reaches 100-110 g/L after weekly divided administration, the maintenance treatment phase will begin. It is recommended to adjust the dose to 2/3 of the treatment dose. Then check the hematocrit every 2-4 weeks to adjust the dose to avoid excessive red blood cell production and maintain the hematocrit and hemoglobin at appropriate levels. If the hematocrit or hemoglobin reaches the above standards after a single weekly administration, it is recommended to extend the single weekly administration time (such as once every two weeks) and adjust the dosage according to the patient's anemia. 2 Surgical perioperative red blood cell mobilization is suitable for elective surgical patients (except cardiovascular surgery) with preoperative hemoglobin values of 100-130 g/L. The dosage is 150 IU/kg body weight, 3 times a week, subcutaneous injection, applied 10 days before surgery to 4 days after surgery, which can reduce intraoperative and postoperative anemia, reduce the need for allogeneic blood transfusion, and accelerate the recovery of postoperative anemia tendency. To prevent iron deficiency during medication, iron supplements can be given at the same time. 3 Anemia caused by tumor chemotherapy When the patient's overall serum erythropoietin level is 200mu/ml, this product is not recommended for treatment. Clinical data show that patients with low basal erythropoietin levels have better efficacy than those with high basal levels. The starting dose is 150IU/kg body weight/time, subcutaneous injection, three times a week. If after 8 weeks of treatment, it cannot effectively reduce the need for blood transfusion or increase the hematocrit, the dose can be increased to 200IU/kg body weight/time, subcutaneous injection, three times a week. If the hematocrit is 40%, the dose of this product should be reduced until the hematocrit drops to 36%. When treatment is restarted or the dose is adjusted to maintain the required hematocrit, this product should be reduced by 25%. If the initial treatment dose achieves a very rapid increase in hematocrit (e.g., an increase of 4% within any 2 weeks), this product should also be reduced. 4. Usage: Use aseptic technique, open the medicine bottle, connect the sterile needle to the sterile syringe, inhale an appropriate amount of liquid medicine, and inject intravenously or subcutaneously.

Adverse Reactions

1 General reactions: A small number of patients may experience headache, low fever, fatigue, etc. at the beginning of medication. Some patients may experience myalgia, joint pain, etc. Most adverse reactions can be improved after symptomatic treatment and will not affect continued medication. In very rare cases, the above symptoms persist and medication discontinuation should be considered. 2 Allergic reactions: A very small number of patients may experience allergic reactions such as rash or urticaria after medication, including anaphylactic shock. Therefore, when using this product for the first time or reusing this product, it is recommended to use a small amount first, and after confirming that there are no abnormal reactions, inject the full amount; if abnormalities are found, the drug should be discontinued immediately and properly handled. 3 Cardiovascular and cerebrovascular system: Increased blood pressure, worsening of existing hypertension, and headaches, impaired consciousness, and convulsions due to hypertensive encephalopathy, and may even cause cerebral hemorrhage. Therefore, during the injection of erythropoietin

Precautions

The following patients are contraindicated to use this product. 1. Patients with uncontrolled severe hypertension. 2. Patients who are allergic to this product and other mammalian cell derivatives, and those who are allergic to human serum albumin. 3. Patients with concurrent infections should control the infection before using this product.

Special Population Medication

Precautions for children: The safety of the drug for premature infants, newborns, and infants has not been established. Prescribers should fully weigh the pros and cons before deciding whether to use this product. Precautions for pregnancy and lactation: The safety of the drug for pregnant and lactating women has not been established. Prescribers should fully weigh the pros and cons before deciding whether to use this product. Precautions for the elderly: When elderly patients use this product, they should pay attention to monitoring blood pressure and hematocrit, and adjust the dosage and frequency of medication appropriately.

Drug Interactions

Not yet clear.

Storage

Store at 2-8℃, away from light, do not freeze, heat or shake. Valid for 2 years.

Packaging Specification

3000IU/vial

Validity Period

24 months

Manufacturer

Shenyang Sunshine Pharmaceutical Co., Ltd.

  • Founded in:

    1993-01-03
  • Address:

    No. 3, 1A, No. 10 Road, Shenyang Economic and Technological Development Zone
  • Tax NO.:

    9121010660460338X6
  • Registered Funds:

    1,000,000,000 Yuan
  • Website:

  • Email:

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