FLUDARABINE PHOSPHATE injection solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Fludarabine Phosphate (UNII: 1X9VK9O1SC) (Fludarabine - UNII:P2K93U8740)

Mevcut itibaren:

Mylan Institutional LLC

INN (International Adı):

Fludarabine Phosphate

Kompozisyon:

Fludarabine Phosphate 25 mg in 1 mL

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

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