FLUDARABINE PHOSPHATE injection powder lyophilized for solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Teva Parenteral Medicines, Inc.

INN（国際名）:

FLUDARABINE PHOSPHATE

構図:

FLUDARABINE PHOSPHATE 50 mg in 2 mL

処方タイプ:

PRESCRIPTION DRUG

認証ステータス:

Abbreviated New Drug Application

製品の特徴

FLUDARABINE PHOSPHATE- FLUDARABINE PHOSPHATE INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
TEVA PARENTERAL MEDICINES, INC.
----------
FLUDARABINE PHOSPHATE FOR INJECTION USP
FOR INTRAVENOUS USE ONLY
5854
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