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Recombinant human granulocyte-stimulating factor injection

Function and Efficacy

This product is human granulocyte stimulating factor (G-CSF) produced by genetic recombination technology. Compared with natural products, its biological activity is basically the same in vivo and in vitro. rhG-CSF 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 granulocyte terminally differentiated cells.

Ingredients

Main ingredients: recombinant human granulocyte stimulating factor, which is made from Escherichia coli containing the gene for highly efficient expression of human granulocyte stimulating factor (G-CSF), after fermentation, separation and high purification. Excipients: mannitol; Tween-80; disodium hydrogen phosphate; citric acid.

Indication

Recombinant human granulocyte-stimulating factor is used for the treatment of patients with non-myeloid malignancies receiving chemotherapy. It can shorten the duration of neutropenia and reduce the incidence of febrile neutropenia.

Usage and Dosage

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

Adverse Reactions

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.

Precautions

Recombinant human granulocyte-stimulating factor should not be used in patients who are allergic to its active degradation products or their by-products.

Special Population Medication

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.

Drug Interactions

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

Storage

Store at 2-8℃ away from light.

Packaging Specification

1.8×10E7IU (300μg): 0.9ml/tube (prefilled syringe)

Validity Period

24 months

Manufacturer

Qilu Pharmaceutical Co., Ltd.

  • Founded in:

    1992-08-21
  • Address:

    No. 317, Xinluo Street, High-tech Zone, Jinan City, Shandong Province
  • Tax NO.:

    91370000614073351Q
  • Registered Funds:

    600 million yuan
  • Website:

  • Email:

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