FLUDARABINE PHOSPHATE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals)

INN (International Name):

fludarabine phosphate

Composition:

fludarabine phosphate 25 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Phosphate for Injection, USP in previously untreated or non-refractory patients with CLL have not been established. Fludarabine phosphate for injection is contraindicated in those patients who are hypersensitive to this drug or its components.

Product summary:

Fludarabine Phosphate for Injection, USP is supplied as follows: 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, USP, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2 to 8.2. Fludarabine Phosphate for Injection, USP is supplied in a clear glass single dose vial (6 mL capacity) and packaged individually. Store refrigerated between 2° and 8°C (36° and 46°F). Sterile, Nonpyrogenic, Preservative-free.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDARABINE PHOSPHATE- FLUDARABINE PHOSPHATE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC. (DBA LEUCADIA PHARMACEUTICALS)
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FLUDARABINE PHOSPHATE FOR INJECTION, USP
(FOR INTRAVENOUS USE ONLY)
Leucadia™
Rx only
WARNING
Fludarabine phosphate for injection should be administered under the
supervision
of a qualified physician experienced in the use of antineoplastic
therapy.
Fludarabine phosphate for injection can severely suppress bone marrow
function.
When used at high doses in dose-ranging studies in patients with acute
leukemia,
fludarabine phosphate for 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/m
/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),
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 for injection should
be evaluated
and closely monitored for hemolysis.
In a clinical investigation using fludarabine phosphate for injection
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 in
combination with pentostatin is not recommended.
DESCRIPTION
Fludarabine Phosphate for Injection, USP contains fludarabine
phosphate, a fluorinated
nucleotide analog of the antiviral agent vidarabine,