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Please see full prescribing and safety information, including boxed warning, for FLUDARABINE vials.

Available in:

  • 50 mg per 2 mL single use vials

  • AP Rated
  • Preservative-free
  • Not made with natural rubber latex

FLUDARABINE Phosphate Injection, USP*

Brand Name Equivalent: FLUDARA® (FLUDARA is a registered trademark of Alcafleu Management GMBH & Co.)
Therapeutic Category: Antineoplastic Agent

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NDC
#25021
Description Strength Fill
Volume
Concentration Container
Size
Closure Unit
of Sale
242-02 Glass Vial 50 mg 2 mL 25 mg per mL 3 mL 13 mm 1
NDC
#0703
Description Strength Fill
Volume
Concentration Container
Size
Closure Unit
of Sale
4852-11 Glass Vial 50 mg 2 mL 25 mg per mL 3 mL 13 mm 1

WARNING: SEVERE BONE MARROW SUPPRESSION, CNS TOXICITY, HEMOLYTIC ANEMIA, AND PULMONARY TOXICITY
Fludarabine phosphate injection should be administered under the supervision of a qualified physician experienced in the us e of antineoplastic therapy. Fludarabine phosphate injection can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, fludarabine phosphate injection was associated with severe neurologic effects , including blindness , coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m2/day for 5 to 7 days) than the recommended dose than the recommended dose. Similar severe central nervous system toxicity, including coma, seizures, agitation and confusion, has been reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia. [see Warnings and Precautions (5.2)]
Instances of life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/ thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia have been reported to occur after one or more cycles of treatment with fludarabine phosphate for injection. Patients undergoing treatment with fludarabine phosphate injection should be evaluated and closely monitored for hemolysis. [see Warnings and Precautions (5.3)]
In a clinical investigation using fludarabine phosphate in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of fludarabine phosphate injection in combination with pentostatin is not recommended. [see Warnings and Precautions (5.5)]