Fludarabine phosphate is available as a lyophilized powder or cake in single-dose vials containing 50 mg of fludarabine phosphate with mannitol 50 mg and sodium hydroxide for pH adjustment.2625 Reconstitute each vial with 2 mL of sterile water for injection to yield a solution containing fludarabine phosphate 25 mg/mL.2625
Fludarabine phosphate is also available as a 25-mg/mL solution for injection in 2-mL single-dose vials.2646 Each mL of solution contains fludarabine phosphate 25 mg with mannitol 25 mg in water for injection and sodium hydroxide for pH adjustment.2646
pH
Reconstituted solutions have a pH ranging from 7.2 to 8.2.2625
The solution for injection has a pH ranging from 6 to 7.1.2646
Trade Name(s)
Fludara
Fludarabine phosphate is administered by intravenous infusion over 30 minutes.2625; 2646 In clinical studies, the drug has been diluted in 100 or 125 mL of dextrose 5% or sodium chloride 0.9%.2625; 2646 The drug also has been administered by rapid intravenous injection and continuous infusion, although the risk of toxicity may be increased.4
Fludarabine phosphate lyophilized powder in intact vials should be stored at controlled room temperature.2625 The manufacturer recommends use of the reconstituted solution within 8 hours because it does not contain antimicrobial preservatives.2625 Nevertheless, the drug is chemically stable in solution, exhibiting less than 2% decomposition in 16 days when stored at room temperature and exposed to normal laboratory light.234
Intact vials of the solution for injection should be stored at 2 to 8°C.2646 The manufacturer recommends use of the solution within 8 hours of initial vial entry because it does not contain antimicrobial preservatives.2646
Fludarabine phosphate (Berlex) 0.2 mg/mL diluted in sodium chloride 0.9% and stored at 22°C did not exhibit an antimicrobial effect on the growth of Enterococcus faecium, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans inoculated into the solution. Diluted solutions should be stored under refrigeration whenever possible, and the potential for microbiological growth should be considered when assigning expiration dates.2160
pH Effects
Fludarabine phosphate is stable in aqueous solution at pH 4.5 to 8. The pH of optimum stability is approximately 7.6.234
Sorption
Fludarabine phosphate 0.04 mg/mL in dextrose 5% or sodium chloride 0.9% was equally stable in either glass or polyvinyl chloride (PVC) containers, exhibiting no loss due to sorption during 48 hours at room temperature or under refrigeration.234
For a list of references cited in the text of this monograph, search the monograph titled References.