Recombinant human interferon α2a for injection

1. Pharmacology: Recombinant human interferon alpha; 2a has broad-spectrum antiviral, anti-tumor and immunomodulatory functions. Interferon binds to cell surface receptors, induces cells to produce a variety of antiviral proteins, inhibits virus reproduction in cells, and improves immune function, including enhancing the phagocytic function of macrophages, enhancing the cytotoxicity of lymphocytes to target cells and the function of natural killer cells. 2. Toxicology: Acute toxicity test: The maximum dose was injected intravenously or intramuscularly into mice, all of them survived, no deaths, and the LD50 was not measured. Long-term toxicity test: Rats were given the drug continuously for one month, and all animals survived without abnormal reactions.

Recombinant human interferon α2a

This product is a white or slightly yellow loose body with no signs of melting; after redissolution, it becomes a clear liquid without any insoluble matter visible to the naked eye.

1. Viral diseases: adult patients with chronic active hepatitis B accompanied by viral replication markers such as HBVDNA, DNA polymerase positive or HBeAɡ positive, adult patients with acute and chronic hepatitis C accompanied by positive HCV antibodies and elevated alanine aminotransferase (ALT) but without liver function decompensation (Child classification A), condyloma acuminatum, herpes zoster, pediatric viral pneumonia and upper respiratory tract infection, chronic cervicitis, hepatitis D, etc. 2. Tumors: hairy cell leukemia, multiple myeloma, non-Hodgkin's lymphoma, chronic leukemia, Kaposi's sarcoma, renal cancer, laryngeal papilloma, melanoma, mycosis fungoides, bladder cancer, basal cell carcinoma, etc.

1. Starting dose for hairy cell leukemia: 3 million international units per day, subcutaneously or intramuscularly, for 16 to 24 weeks. If the tolerance is poor, the daily dose should be reduced to 1.5 million international units, or the frequency of medication should be changed to 3 times a week, or both the dose and the frequency of medication can be reduced. Maintenance dose: 3 million international units each time, subcutaneously or intramuscularly 3 times a week. If the tolerance is poor, the daily dose should be reduced to 1.5 million international units 3 times a week. Treatment course: After about 6 months of using the drug, the doctor will decide whether to continue the drug for patients with good efficacy or to stop the drug for patients with poor efficacy. Note: For patients with thrombocytopenia (platelet count less than 50109/L) or patients at risk of bleeding, subcutaneous injection of recombinant human interferon 2a is recommended. 2. For multiple myeloma, 3 million international units of recombinant human interferon 2a should be used, subcutaneously or intramuscularly 3 times a week. According to the tolerance of different patients, the dose can be increased weekly to the maximum tolerated dose (9 million international units) 3 times a week. This dose can be used continuously except for rapid progression of the disease or extremely poor tolerance. 3. Low-grade non-Hodgkin's lymphoma Recombinant human interferon 2a as an adjuvant therapy for chemotherapy (with or without radiotherapy) can prolong the disease-free survival and progression-free survival of patients with low-grade non-Hodgkin's lymphoma. Recommended dose: After the end of conventional chemotherapy (with or without radiotherapy), 3 million international units of recombinant human interferon 2a are injected subcutaneously 3 times a week for at least 12 weeks. Recombinant human interferon 2a treatment should be started as soon as the patient recovers from the chemoradiotherapy reaction, generally 4 to 6 weeks after chemoradiotherapy. Recombinant human interferon 2a treatment can also be carried out together with conventional chemotherapy regimens (such as combined with cyclophosphamide, prednisone, vincristine and doxorubicin). The cycle is 28 days. On the 22nd to 26th day, 6 million international units/m2 of body surface area of recombinant human interferon 2a are injected subcutaneously or intramuscularly. When recombinant human interferon 2a is combined with chemotherapy for treatment, the use of recombinant human interferon 2a should be carried out simultaneously with chemotherapy. 4. Chronic myeloid leukemia, recombinant human interferon 2a is suitable for patients with chronic myeloid leukemia. 60% of chronic myeloid leukemia patients in the chronic phase can achieve hematological remission after receiving recombinant human interferon 2a treatment regardless of whether they receive other treatments. Two-thirds of these patients achieve complete hematological remission within 18 months after starting treatment. Unlike cytotoxic chemotherapy, recombinant human interferon 2a can maintain cytogenetic remission for more than 40 months. Recommended dose: It is recommended that patients aged 18 years or older receive subcutaneous or intramuscular injections of recombinant human interferon 2a for 8 to 12 weeks. The recommended gradually increasing dose regimen is as follows: 3 million international units per day on days 1 to 3, 6 million international units per day on days 4 to 6, and 9 million international units per day on days 7 to 84. Treatment course: Patients must receive treatment for at least 8 weeks, and at least 12 weeks of treatment are required to achieve better efficacy. Then, the doctor will decide whether to continue the medication for patients with good efficacy or terminate the medication for those who have not seen any improvement in hematological parameters. Patients with good efficacy should continue to take the medication until complete hematological remission is achieved, or continue to take the medication for up to 18 months. All patients who achieve complete hematological remission should continue to receive 9 million international units per day (optimal dose) or 9 million international units three times a week (minimum dose) to achieve cytogenetic remission in the shortest possible time. Although cytogenetic remission has been seen 2 years after the start of treatment, the optimal course of treatment for recombinant human interferon 2a in the treatment of chronic myeloid leukemia has not yet been determined. 5. Chronic active hepatitis B: recombinant human interferon 2a is suitable for the treatment of chronic active hepatitis B in adults with viral replication markers such as HBV DNA, HBeAg and DNA polymerase positive. Recommended dose: The best treatment for chronic active hepatitis B has not yet been determined. Usually 5 million international units are injected subcutaneously 3 times a week for 6 months. If the viral replication markers or HBeAg do not decrease after one month of medication, the dose can be gradually increased and further adjusted to a level that the patient can tolerate. If there is no improvement after 3 to 4 months of treatment, treatment should be stopped. Children: It is reported that it is safe to treat children with chronic hepatitis B with 10 million international units per square meter of body surface area, but its therapeutic effect is still inconclusive. Warning: The efficacy of recombinant human interferon 2a for patients with chronic hepatitis B and human immunodeficiency virus (HIV) infection has not yet been determined. 6. Acute and chronic hepatitis C: recombinant human interferon 2a is suitable for the treatment of adult chronic hepatitis C patients with positive HCV antibodies, elevated alanine aminotransferase (ALT) and no liver decompensation. However, there is no evidence of long-term clinical and histological improvement. Starting dose: 3 million to 5 million international units of recombinant human interferon 2a, 3 times a week, subcutaneously or intramuscularly injected for 3 months as induction therapy. Maintenance dose: Patients with normal serum alanine aminotransferase need to be injected with 3 million international units of recombinant human interferon 2a 3 times a week for 3 months as consolidation therapy for complete remission. Patients with abnormal serum alanine aminotransferase must stop treatment with recombinant human interferon 2a. Note: Most patients who relapse after adequate treatment will relapse within 4 months after the end of treatment. 7. Genital warts: 1 million to 3 million international units of recombinant human interferon 2a, 3 times a week, subcutaneously or intramuscularly injected for 1 to 2 months. Or inject 1 million international units at the base of the affected area every other day for 3 consecutive weeks.

A small number of patients may experience fever, chills, fatigue, myalgia, anorexia, etc. after using this product. Most adverse reactions disappear 48 hours after injection. Other possible adverse reactions include headache, joint pain, loss of appetite, nausea, etc. Some patients may experience granulocytopenia, thrombocytopenia, etc., which can be restored after stopping the drug. If intolerable severe adverse reactions occur, the dose should be reduced or the drug should be stopped, and necessary symptomatic treatment should be given.

1. Those with a history of allergy to recombinant human interferon alpha;2a or any of its components. 2. Those with severe heart disease or a history of heart disease. 3. Those with severe liver, kidney or bone marrow dysfunction. 4. Those with epilepsy and central nervous system damage. 5. Hepatitis patients with advanced decompensated liver disease or cirrhosis. 6. Chronic hepatitis patients who are currently receiving or will receive immunosuppressant treatment in the near future, except for short-term hormone-free treatment. 7. HLA antibody-recognition-related chronic myeloid leukemia patients who are about to receive allogeneic bone marrow transplantation.

Precautions during pregnancy and lactation: Although animal experiments have not shown that recombinant human interferon alpha; 2a has teratogenic effects, its harm to human embryos cannot be ruled out. When recombinant human interferon alpha; 2a was used in early to mid-pregnancy rhesus monkeys at doses far exceeding clinical doses, recombinant human interferon alpha; 2a was observed to have an abortion effect. It is not clear whether recombinant human interferon alpha; 2a can be secreted in human milk, so whether to terminate breastfeeding or medication should be decided based on the importance of the mother. Precautions for the elderly: Elderly patients with heart disease and elderly patients with advanced cancer should undergo electrocardiograms before and during treatment with this preparation, and adjust the dose or stop the medication as needed according to the doctor's advice.

Recombinant human interferon alpha;2a may affect the oxidative metabolism process by reducing the activity of intrahepatic microsomal cytochrome P450. Reports have confirmed that the clearance of theophylline in the body decreases after starting to use recombinant human interferon alpha;2a. Neurotoxicity, hematotoxicity, and cardiac toxicity caused by drugs taken previously or recently will increase due to the use of recombinant human interferon alpha;2a. Interactions will occur when used in combination with drugs with central effects.

Store at 2-8℃ away from light.

3 million IU

24 months

Beijing Shougang Gas Company Limited

• Founded in:

  1997-11-14

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  No. 200, Renli Road, Liqiao Town, Shunyi District, Beijing

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