busulfex- Busulfan injection

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Busulfan (UNII: G1LN9045DK) (Busulfan - UNII:G1LN9045DK)

Beschikbaar vanaf:

ESP Pharma, Inc.

INN (Algemene Internationale Benaming):

Busulfan

farmaceutische vorm:

INJECTION

Samenstelling:

60 mg in 10 mL

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

BUSULFEX® (busulfan) Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. BUSULFEX is contraindicated in patients with a history of hypersensitivity to any of its components.

Product samenvatting:

BUSULFEX is supplied as a sterile solution in 10 mL single-use clear glass vials each containing 60 mg of busulfan at a concentration of 6 mg/mL for intravenous use. NDC 67286-0054-2            10mL (6mg/mL) in packages of eight vials. Unopened vials of BUSULFEX must be stored under refrigerated conditions between 2°-8°C (36°-46°F). HANDLING AND DISPOSAL Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1,2,3,4,5,6 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Marketed by: PDL BioPharma, Inc. Redwood City, CA 94063 Manufactured by: Ben Venue Labs, Inc. Bedford OH 44146 United States Patent numbers are 5,430,057 and 5,559,148. Canadian Patent number is CA2171738. European Union Patent number is EP 0 725 637 B1. Part No. 131401 Rev Date: April 2007

Productkenmerken

BUSULFEX- BUSULFAN INJECTION
ESP PHARMA, INC.
----------
IV BUSULFEX
(BUSULFAN) INJECTION
Caution: Must be diluted prior to use.
RX ONLY
WARNING
BUSULFEX (busulfan) Injection is a potent cytotoxic drug that causes
profound
myelosuppression at the recommended dosage. It should be administered
under the supervision of
a qualified physician who is experienced in allogeneic hematopoietic
stem cell transplantation,
the use of cancer chemotherapeutic drugs and the management of
patients with severe
pancytopenia. Appropriate management of therapy and complications is
only possible when
adequate diagnostic and treatment facilities are readily available.
SEE “WARNINGS” SECTION
FOR INFORMATION REGARDING BUSULFAN-INDUCED PANCYTOPENIA IN
HUMANS.
DESCRIPTION
Busulfan is a bifunctional alkylating agent known chemically as 1,4-
butanediol, dimethanesulfonate.
BUSULFEX (busulfan) Injection is intended for intravenous
administration. It is supplied as a clear,
colorless, sterile, solution in 10 mL single use vials.
Each vial of BUSULFEX contains 60 mg (6 mg/mL) of busulfan, the active
ingredient, a white
crystalline powder with a molecular formula of CH SO O(CH ) OSO CH and
a molecular weight of
246 g/mole. Busulfan is dissolved in N,N-dimethylacetamide (DMA) 33%
vol/vol and Polyethylene
Glycol 400, 67% vol/vol. The solubility of busulfan in water is 0.1
g/L and the pH of BUSULFEX
diluted to approximately 0.5 mg/mL busulfan in 0.9% Sodium Chloride
Injection, USP or 5% Dextrose
Injection, USP as recommended for infusion reflects the pH of the
diluent used and ranges from 3.4 to
3.9.
BUSULFEX is intended for dilution with 0.9% Sodium Chloride Injection,
USP or 5% Dextrose
Injection, USP prior to intravenous infusion.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Busulfan is a bifunctional alkylating agent in which two labile
methanesulfonate groups are attached to
opposite ends of a four-carbon alkyl chain. In aqueous media, busulfan
hydrolyzes to release the
methanesulfonate groups. This produces reactive carbonium ions that
can a