Recombinant human granulocyte-stimulating factor injection

Pharmacology: This product is human granulocyte colony stimulating factor (rhG?/FONTCSF) produced by gene recombination technology. Compared with natural products, the biological activity is basically the same in vivo and in vitro. rhG?/FONTCSF is one of the main cytokines that regulate granulocyte hematopoiesis in the bone marrow. It selectively acts on granulocyte hematopoietic progenitor cells, promotes their proliferation and differentiation, and can increase the function of terminally differentiated granulocyte cells. Toxicology: Acute toxicity: A single injection of 5040mu;g/kg of this product into the tail vein of mice is equivalent to 1000 times the general clinical injection dose. After continuous observation for 10 days, no poisoning reaction was observed. Subacute toxicity: The no-effect dose of mice for 4 weeks (intravenous and subcutaneous injection) and 13 weeks (intravenous injection) was 1mu;g/kg/day. When given more than 10mu;g/kg/day, bone resorption and bone formation of the femoral endothelium of the mouse hind limb, increased ALP, and increased spleen weight can be seen. In the 4-week and 13-week administration (intravenous injection) tests, these phenomena disappeared after drug withdrawal. The ineffective doses for monkeys administered for 4 weeks and 13 weeks (intravenous injection) were 10 mu g/kg/day and 1 mu g/kg/day or more, respectively. A sharp increase in the number of white blood cells (15 to 28 times before administration) occurred after 4 weeks of administration at a dose of 1000 mu g/kg/day, which was considered to be the cause of death from cerebral hemorrhage, while no death occurred after 13 weeks of administration at a dose of 100 mu g/kg/day. In addition, a decrease in proerythrocytes in the bone marrow and an enlarged spleen were observed within each effective dose. After the 13-week administration test, the above phenomena returned to normal. The test results of young mice were the same as those of adult mice, and there was no difference in pharmacological effects and toxicity. Chronic toxicity: Continuous subcutaneous injection of rhG-CSF at 180 mu g/kg for 29 days in Beagle dogs can produce obvious toxic and side effects, mainly manifested as intermittent fever, loss of appetite, deepening of inverted T waves in the ECG II of some animals, thickening or erythema of the skin at the injection site, severe edema of the subcutaneous tissue, large infiltration of inflammatory cells, focal flaky necrosis, proliferation of primitive cells in the bone marrow of some animals, enlargement of the spleen, active growth of spleen cells, transient increase of AST and T-Bil, and pathological changes in the liver cells of some animals. However, the above changes can return to normal after 30 days of drug withdrawal. Long-term administration of 60 mu g/kg can produce mild toxic reactions, mainly manifested as fever in some animals, loss of appetite, irritation damage to the skin tissue at the injection site, and reversible pathological changes in the bone marrow and spleen that are lighter than 180 mu g/kg. Long-term administration of 20 mu g/kg doses did not produce obvious toxic reactions in Beagle dogs. Long-term subcutaneous injection of rhG-CSF 20 mu g/kg is a safe dose for Beagle dogs, which is 4 times the commonly used clinical dose of 5 mu g/kg. The toxicity of rhG-CSF to rats after continuous subcutaneous injection for 90 days has a significant toxic-effect relationship with the increase of dose. 500 mu g/kg is a dose with obvious toxicity. At this dose, the weight growth rate of animals is lower than that of the control group after 1 week, and male animals have not returned to normal levels until the end of the experiment, and the difference is significant. AST transiently increased at 30 days, exceeding the normal range. Among the indicators related to hematopoiesis, the proportion of granulocytes in the bone marrow at 30 days was higher than that in the control group, and the proportion of erythrocytes was relatively lower, and the difference in granulocyte-erythrocyte ratio was significant. The organ coefficient of the spleen was significantly higher than that of the control group and other groups at 30 and 60 days. Reticulocytes were also higher than those of the control group. No obvious abnormalities were found in other indicators. 100 mu g/kg can be considered as a dose with basically no toxic reaction, which is 20 times the commonly used clinical dose. When the animals in this group were given the drug for 3 and 4 weeks, they had a short-term weight loss. At 30 days, the reticulocytes were transiently increased compared with the control group, and the granulocyte-erythrocyte ratio in the bone marrow was significantly higher than that in the control group, which may be the drug's pharmacodynamic response to the granulocyte system. 20mu;g/kg is a safe dose, which is 4 times the commonly used clinical dose. During the 90-day continuous administration process, no obvious toxic effects of this product on animals were found. Only the granulocyte-erythrocyte ratio in the bone marrow was higher than that in the control group, which was considered to be the pharmacodynamic effect of the product itself. Reproductive toxicity: The drug was administered before pregnancy, early pregnancy, and during organ formation (intravenous injection), and the no-effect dose on the reproductive capacity of parent animals, fetuses, and newborn mice was more than 500mu;g/kg/day. When administered during the perinatal period and lactation period, the no-effect dose on the reproductive capacity of parent animals and newborn mice was more than 100mu;g/kg/day and 4mu;g/kg/day, respectively. At more than 20mu;g/kg/day, the development of newborn mice was inhibited. In addition, when the drug was administered during the organogenesis period of rabbits (intravenous injection), the no-effect doses on the reproductive capacity of the parent animals and the fetus were 20 mu;g/kg/day and 5 mu;g/kg/day, respectively. At 80 mu;g/kg/day, the maternal animals had urogenital bleeding and abortion, and the number of surviving fetuses decreased when the dose was above 20 mu;g/kg/day. No teratogenic effect was observed in all the tests. Antigenicity: Antigenicity was observed when guinea pigs, rabbits and mice were given immunoenhancers (FCA or aluminum hydroxide gel) at the same time, but no antigenicity was observed when the drug was administered alone. When rabbits were tested for antigenicity of Escherichia coli heterologous proteins, an increase in antibody titer was observed when FCA was used, but no increase in antibody titer was observed when the drug was used alone. In addition, in clinical trials, no antibody production against the drug and an increase in antibody titer against heterologous proteins from Escherichia coli were found. Others: No abnormalities were observed in systemic allergic reaction tests, mutagenicity tests, local irritation tests and pyrogenicity tests.

Main ingredients: recombinant human granulocyte colony stimulating factor.

This product is a colorless transparent liquid.

1. Neutropenia caused by cancer chemotherapy and other reasons; cancer patients use bone marrow suppressive chemotherapy drugs, especially after strong bone marrow deprivation chemotherapy drugs, injection of this product can help prevent the occurrence of neutropenia, reduce the degree of neutropenia, shorten the duration of agranulocytosis, accelerate the recovery of granulocyte count, and thus reduce the risk of concurrent infection and fever. 2. Promote the increase of neutrophil count after bone marrow transplantation. 3. Neutropenia caused by myelodysplastic syndrome, neutropenia caused by aplastic anemia, congenital and idiopathic neutropenia, myelodysplastic syndrome with neutropenia, and cyclical neutropenia.

1. For neutropenia caused by chemotherapy in tumors. For adult patients whose neutrophil count drops below 1000/mm3 (white blood cell count 2000/mm3) after chemotherapy, 2-5g/kg should be administered subcutaneously or intravenously once a day after chemotherapy. For children whose neutrophil count drops below 500/mm3 (white blood cell count 1000/mm3) after chemotherapy, 2-5g/kg should be administered subcutaneously or intravenously once a day after chemotherapy. When the neutrophil count rises above 5000/mm3 (white blood cell count 10000/mm3), the drug should be stopped. 2. Neutropenia caused by chemotherapy in acute leukemia. For leukemia patients whose white blood cell count is less than 1000/mm3 after chemotherapy, the myeloblasts in the bone marrow are significantly reduced, and no myeloblasts are found in the peripheral blood, 2-5g/kg should be administered subcutaneously or intravenously once a day for adult patients; 2g/kg should be administered subcutaneously or intravenously once a day for children. When the neutrophil count rises back to above 5000/mm3 (white blood cell count 10000/mm3), stop dosing. 3 For adult patients with myelodysplastic syndrome and neutropenia, when the neutrophil count is less than 1000/mm3, 2-5g/kg is administered subcutaneously or intravenously once a day. When the neutrophil count rises back to above 5000/mm3, stop dosing. 4 For adult patients with neutropenia caused by aplastic anemia, when the neutrophil count is less than 1000/mm3, 2-5g/kg is administered subcutaneously or intravenously once a day. When the neutrophil count rises back to above 5000/mm3, reduce the dose or stop dosing as appropriate. 5 Cyclic neutropenia, autoimmune neutropenia and chronic neutropenia. When the neutrophil count of adult patients is less than 1000/mm3, 1g/kg is administered subcutaneously or intravenously once a day. When the neutrophil count of pediatric patients is less than 1000/mm3, 1g/kg is administered subcutaneously or intravenously once a day. When the neutrophil count rises back to above 5000/mm3, the dosage should be reduced or stopped as appropriate. 6. Used to promote the increase of neutrophils in bone marrow transplant patients. Adults should start taking the drug on the 2nd to 5th day after bone marrow transplantation, and 2-5g/kg should be administered subcutaneously or intravenously once a day. Children should start taking the drug on the 2nd to 5th day after bone marrow transplantation, and 2g/kg should be administered subcutaneously or intravenously once a day. When the neutrophil count rises back to above 5000/mm3 (white blood cell count 10000/mm3), stop administering the drug.

1 Musculoskeletal system: sometimes there will be muscle soreness, bone pain, back pain, chest pain. 2 Digestive system: sometimes there will be loss of appetite, or liver alanine aminotransferase and aspartate aminotransferase will increase. 3 Others: some people will have fever, headache, fatigue and rash, ALP and LDH will increase. 4 Very few people will experience shock, interstitial pneumonia, adult respiratory distress syndrome, and increase in immature cells.

1. Patients who are allergic to granulocyte colony stimulating factor and other preparations expressed by Escherichia coli are contraindicated. 2. Patients with severe liver, kidney, heart, and lung dysfunction are contraindicated. 3. Myeloid leukemia patients whose immature granulocytes in the bone marrow have not been significantly reduced or myeloid leukemia patients with immature granulocytes detected in peripheral blood.

Precautions for children: Use with caution in children and give appropriate monitoring; since the safety of the drug for newborns and infants has not been determined, it is recommended not to use the drug. No long-term toxic effects were found in patients aged 4 months to 17 years who took the drug daily, and their growth, development, sexual characteristics and endocrine system were not changed. Precautions for pregnancy and lactation: Safety during pregnancy has not been established. When it is proven that the potential benefits of the drug for pregnant women outweigh the potential risks to the fetus, it should be used. Lactating women should stop breastfeeding before taking the drug. Precautions for the elderly: The physiological function of elderly patients is relatively low, so it is necessary to observe the patient's condition, pay attention to the dosage and interval, and administer the drug with caution. Its safety and effectiveness have not yet been established.

It is not completely clear. Drugs that promote the release of white blood cells (such as lithium) should be used with caution.

Store at 2-8℃ away from light.

300ug/0.9ml/tube (prefilled syringe)

24 months

Beijing Four Rings Bio-Pharmaceutical Co., Ltd.

• Founded in:

  1988-10-08

• Address:

  No. 5 Jian'an Street, Beijing Economic and Technological Development Zone, Beijing

• Tax NO.:

  91110302101942400P

• Registered Funds:

  350.92759 million yuan

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