FLUDARABINE Phosphate for Injection, USP
Fludarabine
Please see full prescribing and safety information for Fludarabine vials.
 
LATEX-FREE • PRESERVATIVE-FREE • AP RATED
 
Brand Name Equivalent: FLUDARA® (FLUDARA is a registered trademark of Alcafleu Management GMBH & Co.)
  Electronic Catalog
Therapeutic Category: Antineoplastic Agent

  • Consider these SAGENT benefits:
  • • Available in:
  •   - 50 mg single-dose vials
    • LATEX-FREE
  • • Preservative-free
  • • Discover PreventIV MeasuresSM packaging features:
  •   - Easy-to-read drug name and dosage strength
  •   - Bar codes included on the vial and the carton for ease of scanning
  •   - Unique label design to help differentiate this product from other drug products
  •   - Yellow and black cytotoxic warning flag designed to caution healthcare workers who handle the product
  • • Enhanced packaging and labeling designed to promote safety and help reduce medication errors
NDC #25021
 Description Strength Fill Volume Concentration
 Container Size Closure Unit of Sale
 Package Insert Storage Requirements Product Photos 360o View
205-05 Glass Vial 50 mg N/A
 N/A
 5 mL 20 mm 1 Package Insert Package Insert
 Product Photos 360 Product View
• Each vial contains: fludarabine phosphate 50 mg and excipients: mannitol and sodium hydroxide 1N.
Fludarabine Catalog Insert    MSDS Sheet    Bar Codes    Wholesaler Item Numbers
WARNINGS:
Fludarabine Phosphate for Injection, USP should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludarabine Phosphate for Injection, USP can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, Fludarabine Phosphate for Injection, USP 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. 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.
Instances of life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evan’s syndrome, and acquired hemophilia have been reported to occur after one or more cycles of treatment with Fludarabine Phosphate for Injection, USP. Patients undergoing treatment with Fludarabine Phosphate for Injection, USP should be evaluated and closely monitored for hemolysis.
In a clinical investigation using Fludarabine Phosphate for Injection, USP 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 for Injection, USP in combination with pentostatin is not recommended.
   Please refer to full prescribing information.
 

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LATEX-FREE = There is no natural rubber latex in the vial container closure or label adhesive in this SAGENT product.
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