FLUDARABINE- fludarabine phosphate injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

FLUDARABINE PHOSPHATE (UNII: 1X9VK9O1SC) (FLUDARABINE - UNII:P2K93U8740)

Beszerezhető a:

Fresenius Kabi USA, LLC

INN (nemzetközi neve):

FLUDARABINE PHOSPHATE

Összetétel:

FLUDARABINE PHOSPHATE 25 mg in 1 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Fludarabine Phosphate Injection, USP is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.  The safety and effectiveness of Fludarabine Phosphate Injection, USP in previously untreated or non-refractory patients with CLL have not been established. Fludarabine Phosphate Injection, USP is contraindicated in those patients who are hypersensitive to this drug or its components.

Termék összefoglaló:

Fludarabine Phosphate Injection, USP is supplied as a clear, sterile solution.  Each mL contains 25 mg of fludarabine phosphate, 25 mg of mannitol, water for injection, q.s.; and sodium hydroxide to adjust pH to 6.8.  The pH range for the final product is 6.0 to 7.1. REFRIGERATE AT:  2° to 8°C (36° to 46°F). The container closure is not made with natural rubber latex.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

FLUDARABINE - FLUDARABINE PHOSPHATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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FLUDARABINE PHOSPHATE INJECTION, USP
Rx only
FOR INTRAVENOUS USE ONLY
WARNING
Fludarabine should be administered under the supervision of a
qualified physician experienced in
the use of antineoplastic therapy. Fludarabine can severely suppress
bone marrow function.
When used at high doses in dose-ranging studies in patients with acute
leukemia, fludarabine 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/m
/day for 5 to 7 days) than the recommended dose. Similar severe
central
nervous system toxicity has been rarely (0.2%) 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 hemolytic
anemia have been reported
to occur after one or more cycles of treatment with fludarabine.
Patients undergoing treatment
with fludarabine should be evaluated and closely monitored for
hemolysis.
In a clinical investigation using fludarabine 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 in combination with
pentostatin is not recommended.
DESCRIPTION
Fludarabine Phosphate Injection, USP contains fludarabine phosphate, a
fluorinated nucleotide analog of
the antiviral agent vidarabine, 9-ß-D-arabinofuranosyladenine (ara-A)
that is relatively resistant to
deamination by adenosine deaminase. Each mL contains 25 mg of the
active ingredient fludarabine
phosphate, 25 mg of mannitol, water for injection, q.s., and sodium
hydroxide to adjust pH to 6.8. The
pH range for the final product is 6.0 to 7.1. Fludarabine Phosphate
Injection, USP is a sterile solution
intended for intravenous administration.
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