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:

Hospira, Inc.

INN (International Name):

FLUDARABINE PHOSPHATE

Composition:

FLUDARABINE PHOSPHATE 50 mg in 2 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, USP in previously untreated or non-refractory patients with CLL have not been established. Fludarabine phosphate, USP is contraindicated in those patients who are hypersensitive to this drug or its components.

Product summary:

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 pH range for the final product is 7.2 to 8.2. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Store upright. Fludarabine Phosphate for Injection, USP is supplied in a clear glass single dose vial and cartoned individually. NDC 61703-344-18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDARABINE PHOSPHATE- FLUDARABINE PHOSPHATE INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
HOSPIRA, INC.
----------
FLUDARABINE PHOSPHATE FOR INJECTION, USP
FOR INTRAVENOUS USE ONLY ONLY
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 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/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),
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.
DESCRIPTION
Fludarabine Phosphate for Injection, USP contains fludarabine
phosphate, USP, a fluorinated nucleotide
analog of the antiviral agent vidarabine,
9-β-D-arabinofuranosy