FLUDARABINE PHOSPHATE injection

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Mylan Institutional LLC

INN (Nome Internazionale):

FLUDARABINE PHOSPHATE

Composizione:

FLUDARABINE PHOSPHATE 25 mg in 1 mL

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

FLUDARABINE PHOSPHATE- FLUDARABINE PHOSPHATE INJECTION
MYLAN INSTITUTIONAL LLC
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FLUDARABINE PHOSPHATE INJECTION, USP
RX ONLY
FOR INTRAVENOUS USE ONLY
WARNING
Fludarabine Phosphate Injection should be administered under the
supervision of a qualified
physician experienced in the use of antineoplastic therapy.
Fludarabine Phosphate Injection can
severely suppress bone marrow function. When used at high doses in
dose-ranging studies in
patients with acute leukemia, fludarabine phosphate 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 5–7 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 injection. Patients undergoing treatment with
fludarabine phosphate
injection should be evaluated and closely monitored for hemolysis.
In a clinical investigation using fludarabine phosphate 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 injection in combination with pentostatin is not
recommended.
DESCRIPTION
Fludarabine Phosphate Injection contains fludarabine phosphate, a
fluorinated nucleotide analog of the
antiviral agent vidarabine, 9-ß D-arabinofuranosyladenine (ara-A)
that is relatively resistant to
deamination by adenosine deaminase. Each mL contains 25 m