FLUDARABINE PHOSPHATE injection, powder, lyophilized, for solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Actavis Pharma, Inc.

INN (nemzetközi neve):

FLUDARABINE PHOSPHATE

Összetétel:

FLUDARABINE PHOSPHATE 50 mg in 2 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Fludarabine Phosphate for Injection 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 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.

Termék összefoglaló:

Fludarabine Phosphate for Injection, USP is a white, lyophilized solid cake. Each single-dose 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. Fludarabine Phosphate for Injection, USP, NDC 45963-609-55, is supplied in a clear glass single-dose vial and packaged in a carton. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F), in the original package. The container closure is not made with natural rubber latex. Sterile, Nonpyrogenic, Preservative-free

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

FLUDARABINE PHOSPHATE- FLUDARABINE PHOSPHATE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
ACTAVIS PHARMA, INC.
----------
FLUDARABINE PHOSPHATE FOR INJECTION, USP
FOR INTRAVENOUS USE ONLY
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 USP, a
fluorinated nucleotide analog of the antiviral agent vidarabine,
9-β-D-
arabinofuranosyladenine (ara-A) that is r