A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Leustatin Online, Description, Chemistry, Ingredients - Cladribine
Leustatin Online, Description, Chemistry, Ingredients - Cladribine
LEUSTATIN® (cladribine)
Injection
For Intravenous Infusion Only
DESCRIPTION
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WARNING
LEUSTATIN (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 LEUSTATIN 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 LEUSTATIN
(4 to 9 times the recommended dose for Hairy Cell Leukemia), especially
when given concomitantly with other nephrotoxic agents/ therapies.
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LEUSTATIN (cladribine) Injection (also commonly known as 2-chloro-2'-deoxy- ß-D-adenosine)
is a synthetic antineoplastic agent for continuous intravenous infusion.
It is a clear colorless, sterile, preservative-free, isotonic solution.
LEUSTATIN Injection is available in single-use vials containing 10 mg
(1 mg/mL) of cladribine, a chlorinated purine nucleoside analog. Each
milliliter of LEUSTATIN 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-ß-D-erythropento-furanosyl)
purine and the structure is represented below:
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