Please see full prescribing and safety information, including boxed warning, for FLUDARABINE vials.
Available in:
- 50 mg per 2 mL single-dose vials
Benefits:
- AP Rated
- Preservative-free
- Not made with natural rubber latex
Downloads:
FLUDARABINE Phosphate Injection, USP*
Therapeutic Category: Antineoplastic Agent
PreventIV Measures® Features:
- Easy-to-read drug name and dosage strength to aid in identifying the right product
- Bar codes included on the vial and carton for ease of scanning
- Unique label design to help products stand out on the shelf
- Enhanced packaging and labeling designed to promote safety and help reduce the risk of medication errors
| 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 |
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)]
