CLADRIBINE injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

CLADRIBINE (UNII: 47M74X9YT5) (CLADRIBINE - UNII:47M74X9YT5)

זמין מ:

Pfizer Laboratories Div Pfizer Inc.

INN (שם בינלאומי):

CLADRIBINE

הרכב:

CLADRIBINE 1 mg in 1 mL

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CLADRIBINE- CLADRIBINE INJECTION
PFIZER LABORATORIES DIV PFIZER INC.
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CLARIBINE INJECTION
FOR INTRAVENOUS INFUSION ONLY
BOXED WARNING
Cladribine Injection should be administered under the supervision of a
qualified physician
experienced in the use of antineoplastic therapy. Suppression of bone
marrow function should be
anticipated. This is usually reversible and appears to be dose
dependent. Serious neurological
toxicity (including irreversible paraparesis and quadraparesis) has
been reported in patients who
received Cladribine Injection by continuous infusion at high doses (4
to 9 times the recommended
dose for Hairy Cell Leukemia). Neurologic toxicity appears to
demonstrate a dose relationship;
however, severe neurological toxicity has been reported rarely
following treatment with standard
cladribine dosing regimens.
Acute nephrotoxicity has been observed with high doses of Cladribine
(4 to 9 times the
recommended dose for Hairy Cell Leukemia), especially when given
concomitantly with other
nephrotoxic agents/therapies.
DESCRIPTION
Cladribine Injection (also commonly known as 2-chloro-2΄-deoxy- β
-D-adenosine) is a synthetic
antineoplastic agent for continuous intravenous infusion. It is a
clear, colorless, sterile, preservative-
free, isotonic solution. Cladribine Injection is available in
single-use vials containing 10 mg (1 mg/mL)
of cladribine, a chlorinated purine nucleoside analog. Each milliliter
of Cladribine Injection contains 1
mg of the active ingredient and 9 mg (0.15 mEq) of sodium chloride as
an inactive ingredient. The
solution has a pH range of 5.5 to 8.0. Phosphoric acid and/or dibasic
sodium phosphate may have been
added to adjust the pH to 6.3±0.3.
The chemical name for cladribine is
2-chloro-6-amino-9-(2-deoxy-β-D-erythropento-furanosyl) purine
and the structure is represented below:
cladribine MW 285.7
CLINICAL PHARMACOLOGY
CELLULAR RESISTANCE AND SENSITIVITY:
The selective toxicity of 2-chloro-2΄-deoxy-β-D-adenosine towards
certain normal and malignant
lymphocyte and monocy