Fludarabine phosphate

This product is a fluorinated nucleoside analog of the antiviral drug Vidarabine. It has an anti-tumor mechanism similar to Ara-C, but is not deaminated and inactivated by adenosine deaminase. After ingestion, it is rapidly dephosphorylated to generate 2-fluoroarabinoadenosine (F-Ara-A), which is phosphorylated in the cell to become F-Ara-ATP with anti-tumor activity. It can inhibit DNA polymerase, DNA primase, DNA helicase and ribonucleotide reductase, and can also be incorporated into tumor cell DNA and RNA chains to stop chain extension and inhibit DNA and RNA synthesis. However, its precise mechanism needs to be further clarified. This product can inhibit the growth of many human tumors, such as non-Hodgkin's lymphoma, leukemia, breast cancer, non-small cell lung cancer and ovarian tumors in tissue culture and tumor animal models, and it also has the effect of enhancing the activity of many anti-tumor drugs in vitro. This product can be used in combination with gallium nitrate, cytarabine, mitoxantrone or Ara-C plus cisplatin to enhance the killing effect on tumor cells.

The main ingredient of this product is fludarabine phosphate, and its chemical name is 9-β-D-arabino-furanose-2-fluoroadenine-5'-phosphate

This product is white loose lumps and powder.

For the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) whose disease has not improved or has progressed during or after treatment with at least one standard alkylating agent-containing regimen.

Adult use: The recommended dose is 25 mg/m2 of fludarabine phosphate per day for 5 consecutive days, with one intravenous course of treatment every 28 days. Each drug is prepared with 2 ml of water for injection, and each ml of the final solution contains 25 mg of fludarabine phosphate. Use a syringe to draw out the required drug dose calculated according to the body surface area. If intravenous injection is required, use 0.9% sodium chloride to dilute the required dose of the drug into 100 ml of solution, and the infusion time should last for more than 30 minutes. The length of medication time is determined by the success of the treatment and the tolerance of the drug. CLL patients should use Fudahua until the best therapeutic effect is achieved (complete remission or partial remission, usually 6 courses of treatment) before stopping the drug. There are no reports of serious local side effects caused by the use of Fudahua. Reference: The recommended dose is 25 mg/m2, intravenous drip for 30 minutes per day for 5 consecutive days, with an interval of 28 days between each treatment. The dose can be reduced or delayed according to the blood or non-blood (such as neuro) toxicity, and the elderly should be closely monitored. For patients with renal insufficiency and bone marrow damage, the dose can be adjusted if necessary. The optimal duration of treatment has not been established, and it is recommended to continue treatment for 3 cycles after the maximum effect is achieved. Hematological monitoring should be performed carefully during administration. Use in children, pregnant women and lactating women: The safety and effectiveness of fludarabine phosphate in children have not been established. Embryotoxicity studies conducted in animals have shown that the drug has potential embryotoxicity and/or teratogenicity, which also has corresponding risks when converted to human therapeutic doses. Preclinical studies conducted in mice have found that fludarabine phosphate and/or metabolites are transported through the fetal-placental barrier. There has been a report on the use of fludarabine phosphate in early pregnant women causing skeletal and cardiac malformations in newborns. Therefore, Fudahua should not be used during pregnancy. Women of childbearing age should avoid pregnancy when taking the drug, and should immediately notify the treating physician if pregnancy is discovered. It is not clear whether fludarabine phosphate is secreted through human breast milk. However, preclinical data have shown that fludarabine phosphate and/or metabolites can be transferred from maternal blood to breast milk. Therefore, lactating women should stop using fludarabine phosphate.

This product can cause serious adverse reactions. About 59% of patients experience dose-related bone marrow suppression, including anemia, thrombocytopenia, neutropenia and CD4 cell deficiency. This adverse reaction is reversible, and the number of peripheral blood cells should be measured regularly to prevent adverse reactions in the hematopoietic system. Other adverse reactions include mild to moderate nausea and vomiting (36%), fever (60%), pain (20%), infection (33%), chills, diarrhea, anorexia, discomfort, drug rash, edema, cough, pancreatitis, etc. Tumor lysis syndrome may also occur sometimes. It may manifest as chest pain, hematuria, hyperuricemia, hyperphosphatemia, hypocalcemia, hyperkalemia, urate crystalluria, and renal failure. It may occur in the first week of treatment, and preventive measures should be taken for those patients at risk.

The following patients should not use this drug: patients who are allergic to the drug or its ingredients; patients with renal insufficiency with a creatinine clearance rate lower than 30 ml/min; patients with decompensated hemolytic anemia; pregnant and lactating women should not use this drug.

Not yet clear.

Store at room temperature (maximum temperature 30°C).

Guangdong Lingnan Pharmaceutical Co., Ltd.

• Founded in:

  1991-04-12

• Address:

  No. 5, Muxi 8th Road, Xilian Town, Wujiang District, Shaoguan City

• Tax NO.:

  91440000190333956C

• Registered Funds:

  11.38 million yuan

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