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fludarabine phosphate for injection, USP

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

fludarabine phosphate for injection, USP Quick Finder

WARNING: Fludarabine Phosphate for Injection, USP should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludarabine Phosphate...

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INDICATIONS AND USAGE

Fludarabine Phosphate for Injection, USP is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during...

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DOSAGE AND ADMINISTRATION

Usual Dose: The recommended adult dose of Fludarabine Phosphate for Injection, USP is 25 mg/m2 administered...

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CONTRAINDICATIONS

Fludarabine phosphate, USP is contraindicated in those patients who are hypersensitive to this drug or its components.

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WARNINGS

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PRECAUTIONS

General: Fludarabine phosphate, USP is a potent antineoplastic...

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ADVERSE REACTIONS

The most common adverse events include myelosuppression (neutropenia, thrombocytopenia and anemia), fever and chills, infection, and nausea and vomiting. Other commonly reported events include malaise,...

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OVERDOSAGE

High doses of fludarabine phosphate, USP (see WARNINGS section) have been associated with an irreversible central nervous system...

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DESCRIPTION

Fludarabine Phosphate for Injection, USP contains fludarabine phosphate, USP, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-β-D-arabinofuranosyladenine (ara-A) that is relatively resistant...

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CLINICAL PHARMACOLOGY

Fludarabine phosphate, USP is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite...

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REFERENCES

1.
Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.
2.
OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2....
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HOW SUPPLIED

Fludarabine Phosphate for Injection, USP is supplied as a white, lyophilized solid cake. Each vial contains 50 mg of fludarabine phosphate, USP, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The...

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