CLADRIBINE injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Hisun Pharmaceuticals USA, Inc.

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Cladribine Injection, USP is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms. Cladribine Injection, USP is contraindicated in those patients who are hypersensitive to this drug or any of its components.

leaflet_short:

Cladribine Injection, USP is supplied as a sterile, preservative-free, isotonic solution containing 10 mg (1 mg/mL) of cladribine as 10 mL filled into a single-dose clear flint glass 20 mL vial, individually boxed, with the trademark “Novaplus”. NDC 42658-010-91. Store refrigerated 2° to 8°C (36° to 46°F). Protect from light during storage.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CLADRIBINE- CLADRIBINE INJECTION, SOLUTION
HISUN PHARMACEUTICALS USA, INC.
----------
CLADRIBINE INJECTION, USP
FOR INTRAVENOUS INFUSION ONLY
RX ONLY
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, USP (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, USP is available
in single-dose vials containing 10 mg (1 mg/mL) of cladribine, a
chlorinated purine
nucleoside analog. Each milliliter of cladribine injection, USP
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:
CLINICAL PHARMACOLOGY
CELLULAR RESISTANCE AND SENSITIVITY
The selective toxicity of 2-chloro-2΄-deoxy-β-D-adenosine towards
certain normal and
malignant lymphocyte a