FLUDARABINE Phosphate for Injection, USP

LATEX-FREE • PRESERVATIVE-FREE • AP RATED

Brand Name Equivalent: FLUDARA	Electronic Catalog
Therapeutic Category: Antineoplastic Agent

Consider these SAGENT benefits:
• Available in 50 mg single-dose vials
• LATEX-FREE
• Preservative-free
• Enhanced packaging and labeling designed to promote safety and help reduce medication errors,
including:
- Easy-to-read drug name and dosage strength
- Bar coding

NDC #25021	Description	Strength	Fill Volume	Concentration	Container Size	Closure	Unit of Sale	Package Insert	Storage Requirements	Product Photos	360^o View
205-05	Glass Vial	50 mg	N/A	N/A	5 mL	20 mm	1

• Each vial contains: fludarabine phosphate 50 mg and excipients, manitol 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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