White or yellowish white crystalline powder
864.2°C at 760 mmHg
Cool,dry and hermetic place
Chemical reagents, fine chemicals, pharmaceutical intermediates, materials intermediates
Adult Fludarabine phosphate should be used under the supervision of a doctor with extensive anti-tumor treatment experience.
It is strongly recommended that fludarabine phosphate can only be used for intravenous injection. Although there have been no reported cases of severe local adverse reactions caused by intravenous injections, it is necessary to avoid targeted use around the veins.
The recommended dose is 25 mg/m2 fludarabine phosphate, which is administered intravenously for 5 days every 28 days. Each vial contains 2 mL of water for injection, and each ml of the preparation solution should contain 25 mg of fludarabine phosphate.
The corresponding dose (calculated according to the patient's body surface area) is drawn into the syringe. If it is an intravenous bolus, it should be diluted with 10 mL of 0.9% saline. Alternatively, the required dose drawn into the syringe can also be diluted with 100 mL of 0.9% saline and the instillation time should be more than 30 minutes.
The duration of treatment depends on the effectiveness of the treatment and the tolerance to the drug.
In patients with CLL, fludarabine phosphate should be used until the best therapeutic effect (complete or partial remission, usually 6 courses) before discontinuation.
Renal insufficiency The dose of patients with renal insufficiency should be adjusted accordingly. When the creatinine clearance rate is 30-70 mL/min, the dose should be reduced by 50%, and hematological changes should be closely examined to evaluate the toxicity of the drug. If the creatinine clearance is less than 30 mL/min. Fludarabine phosphate treatment should be banned.
Excessive high doses of fludarabine phosphate are associated with the toxicity of the irreversible central nervous system, manifested as late blindness, coma and death. High doses of fludarabine are also associated with severe thrombocytopenia and neutropenia caused by myelosuppression.
There are no known specific antagonists of fludarabine in excess, and the overdose treatment mainly includes discontinuation of drugs and supportive care.
Instructions for use: handling and destruction Fludarabine phosphate should not be operated by pregnant medical staff.
Proper operation and destruction procedures should be followed. Operation and destruction should be considered in accordance with the guidelines for cytotoxic drugs. Any spilled or discarded material can be destroyed by incineration.
Special instructions for intravenous use of the formulation Fludarabine phosphate should be prepared under sterile conditions by the addition of sterile water for injection. When prepared by adding 2 mL of sterile water for injection, the solid powder should dissolve completely quickly. Each milliliter of final solution will contain 25 mg of fludarabine phosphate, 25 mg of mannitol, and sodium hydroxide adjusted to a pH of 7.7. The final product has a pH range of 7.2-8.2. In clinical studies, the product was diluted with 100 mL or 125 mL of 5% dextrose injection or 0.9% saline.
Care should be taken when handling and preparing fludarabine phosphate injections. Latex gloves and safety glasses are recommended to prevent drug contact due to broken vials or other accidental spills. If the solution comes into contact with the skin or mucous membranes, the area should be thoroughly washed with water and soap. If you come into contact with your eyes, wash it thoroughly with plenty of water. Avoid drug contact due to inhalation.