Recombinant human interleukin-11 for injection

This product is a platelet-promoting growth factor produced by genetic 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 use 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.

The active ingredient of this product is recombinant human interleukin-11, and other inactive ingredients are glycine 11.25 mg, sodium chloride 8.78 mg, disodium hydrogen phosphate dodecahydrate 2.19 mg, and sodium dihydrogen phosphate dihydrate 0.61 mg.

This product is a sterile freeze-dried preparation, off-white loose body, which can be quickly dissolved after adding water for injection.

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. platelets ≤ 50×109/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 50μg/kg, which should be started 24-48 hours after the end of chemotherapy or after thrombocytopenia occurs. Each vial of interleukin-11 should be diluted with 1 ml of injection water before use and injected subcutaneously immediately. Once a day, the course of treatment is generally 7-14 days. The drug should be stopped in time after the platelet count recovers.

In addition to the adverse reactions of chemotherapy itself, most of the adverse reactions of recombinant human IL-11 are mild to moderate and can be quickly resolved after discontinuation of the drug. About 10% of clinical patients experienced the following adverse events during the observation period, including fatigue, pain, chills, abdominal pain, infection, nausea, constipation, dyspepsia, ecchymosis, myalgia, bone pain, nervousness and alopecia. The incidence of most of these events is similar to that of the placebo control group, and the clinical adverse reactions with an incidence higher than that of the placebo control group include: Systemic: edema, headache, fever and neutropenic fever. Cardiovascular system: tachycardia, vasodilation, palpitations, syncope, atrial fibrillation and atrial flutter. Digestive system: nausea, vomiting, mucositis, diarrhea, oral candidiasis. Nervous system: dizziness, insomnia. Respiratory system: dyspnea, rhinitis, increased cough frequency, pharyngitis, pleural effusion. Others: rash, conjunctival congestion, and occasional transient blurred vision after medication. In addition, the incidence of adverse reactions such as amblyopia, paresthesia, dehydration, skin depigmentation, exfoliative dermatitis, and eye hemorrhage in the treatment group was also higher than that in the placebo control group. However, statistical processing could not determine whether the occurrence of these adverse events was related to the effects of recombinant human IL-11. Except for the significantly higher incidence of amblyopia in the treatment group (10 cases [14%]) than in the control group (2 cases [3%]), the incidence of other serious or life-threatening adverse events between the two groups was roughly the same. Two patients died suddenly during the observation period, and the researchers believed that the cause of death may be partly related to the medication. Both patients received high-dose ifosfamide chemotherapy and were still taking diuretics daily, and both had severe hypokalemia (decreased hemoglobin concentration. The expansion of plasma volume also caused a decrease in the concentration of albumin and other plasma proteins such as ferritin and γ-globulin, and a corresponding decrease in blood calcium concentration, but without clinical manifestations. Daily subcutaneous injection of recombinant human IL-11 can cause a 2-fold increase in plasma fibrinogen concentration. The plasma concentrations of some other acute phase proteins also increased accordingly. These indicators can return to normal after discontinuation of the drug. In addition, in healthy subjects, it was observed that recombinant human IL-11 can cause an increase in the concentration of Von Willebrand factor (vWF) in the normal polymer form in plasma.

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 drug enzymes.

Store in a low temperature environment below 2-8℃.

3mg (24 million U)/bottle

Chengdu DIAO Jiuhong Pharmaceutical Factory

• Founded in:

  1996-11-27

• Address:

  No. 16, Gaopeng East Road, Chengdu Hi-tech Zone

• Tax NO.:

  91510100202172097P

• Registered Funds:

  10 million yuan

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