Recombinant human interleukin-11 for injection

Pharmacological action: This product is a platelet-promoting growth factor produced by gene recombination technology. It can directly stimulate the proliferation of hematopoietic stem cells and megakaryocyte progenitor cells, induce the maturation and differentiation of megakaryocytes, increase the production of platelets in the body, thereby increasing the platelet count in the blood, while there is no significant change in platelet function. Preclinical studies have shown that after the application of this product in vivo, the mature megakaryocytes are completely normal in ultrastructure, and the morphology, function and lifespan of the generated platelets are also normal. Toxicological studies: Safety pharmacology: In various animal models, some non-hematopoietic system effects of this product have been observed, including controlling the growth of intestinal epithelial cells, inhibiting lipid formation, inducing the synthesis of acute phase reaction proteins, inhibiting the secretion of pro-inflammatory factors by macrophages, stimulating osteoclast activity and neural development, etc. Repeated administration toxicity: Non-human primates were given continuous administration for 2-13 weeks, and joint capsule and tendon fibrosis and periosteum thickening were observed, but it is not clear whether patients with long-term medication will have similar changes. Genetic toxicity: In vitro studies have shown that this product has no mutagenic effect. Reproductive toxicity: At 2-20 times the normal human dose, the estrus period of rats can be prolonged, but even at a dose of up to 1000 mg/kg/day, there is no effect on the fertility of rats. In studies on rat fertility and early embryonic development and studies on organogenesis in rats and rabbits, maternal toxicity was observed when the dose of the drug was 2-20 times the human dose (≥100 mg/kg/day) for rats and 0.02-2 times the human dose (≥1ug/kg/day) for rabbits. In rat experiments, transient reduction in sexual activity and breathing difficulties, prolonged estrus, increased early embryonic mortality, and reduced fetal survival rates were observed in maternal rats. In addition, at 20 times the human dose, rat embryo weight decreased and embryonic development was delayed (the number of ossified sacral and coccygeal vertebrae decreased), but no long-term behavioral or developmental abnormalities were observed. Decreased food intake and excretion, weight loss, miscarriage, increased embryonic and fetal mortality, etc. were observed in domestic rabbits, but no teratogenic effects were observed. There is no adequate and strictly controlled clinical research data for pregnant women. This product can only be used during pregnancy if its potential benefits outweigh its potential harm to the fetus. It is not clear whether this product is secreted from human milk. Given that many drugs can be secreted from human milk and this product may cause serious adverse reactions to breastfeeding infants, it should be decided whether to stop breastfeeding or discontinue the drug based on the importance of the drug to the mother. Carcinogenicity: No studies have been conducted on the potential carcinogenicity of this product. In vitro studies have shown that this product did not show growth stimulating effects on a series of tumor cells from different patients.

Main ingredients: recombinant human interleukin-11.

It is used to treat Ⅲ and Ⅳ degree thrombocytopenia after chemotherapy for solid tumors and non-myeloid leukemia. For patients with solid tumors and non-myeloid leukemia who develop Ⅲ and Ⅳ degree thrombocytopenia (i.e. platelet count ≤ 5×109/L) after the previous course of chemotherapy, this product should be used before the next course of chemotherapy to reduce bleeding caused by thrombocytopenia and dependence on platelet transfusion. Granulocyte colony stimulating factor (rhG-CSF) can be used in combination with patients with leukopenia if necessary.

According to the clinical research results of this product, the recommended dosage of this product is 50 mg/kg, which should be injected subcutaneously 24-48 hours after the end of chemotherapy or after thrombocytopenia occurs (diluted with 1 ml of injection water), once a day, and the course of treatment is generally 7-14 days. The drug should be stopped promptly after the platelet count recovers.

Similar products have caused severe allergic reactions abroad. Therefore, those who are allergic to interleukin-11 and other ingredients in this product are prohibited from using it, and those who have a history of allergy to blood products and other biological agents expressed by Escherichia coli should use it with caution.

No adverse effects were found when using recombinant human interleukin-11 and G-CSF at the same time on the efficacy of both drugs. The interaction between recombinant human interleukin-11 and some other drugs has not been evaluated yet. According to the existing in vitro and animal test data, there is no interaction between recombinant human interleukin-11 and some known substrates of P450 enzymes.

Refrigerate at 2-8°C (36-46°F) away from light

1mg (8 million units)/vial

Xiamen Amoytop Biotech Co., Ltd.

• Founded in:

  1996-08-07

• Address:

  No. 330, Wengjiao Road, Xinyang Industrial Zone, Haicang, Xiamen

• Tax NO.:

  913502002600603688

• Registered Funds:

  406.8 million yuan

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