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 50 mg in 2 mL

Prescription type:

PRESCRIPTION DRUG

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 IV USE ONLY)
SAGENT
RX 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),
Evans 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-ara