FLUDARABINE PHOSPHATE- 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:

Sagent 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
SAGENT PHARMACEUTICALS
----------
FLUDARABINE PHOSPHATE FOR INJECTION, USP
(FOR INTRAVENOUS USE ONLY)
SAGENT™
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,
9-β-D-arabinofuranosyladenine (ara-A) t